<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02228096</url>
  </required_header>
  <id_info>
    <org_study_id>CCTL019B2205J</org_study_id>
    <secondary_id>2015-003736-13</secondary_id>
    <nct_id>NCT02228096</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients</brief_title>
  <acronym>ENSIGN</acronym>
  <official_title>A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a single arm, open-label, multi-center, phase II study to determine the efficacy and&#xD;
      safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell&#xD;
      acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or&#xD;
      relapsed after allogeneic stem cell transplant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2014</start_date>
  <completion_date type="Actual">May 24, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)</measure>
    <time_frame>within 6 months after CTL019 infusion</time_frame>
    <description>ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Remission Rate (ORR) Per Local Investigator Assessment (for Lymphoblastic Lymphoma Patients Only)</measure>
    <time_frame>6 months after CTL019</time_frame>
    <description>Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and cerebrospinal fluid (CSF). This primary endpoint was based on the local investigator assessment. No participants with lymphoblastic lymphoma were infused in this study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment</measure>
    <time_frame>Month 6</time_frame>
    <description>Evaluate the percentage of participants who achieved CR or CRi at Month 6 without SCT between tisagenlecleucel infusion and Month 6 response assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Achieved CR or CRi and Then Proceeded to SCT While in Remission Prior to Month 6 Response - Per IRC Assessment</measure>
    <time_frame>prior to Month 6</time_frame>
    <description>Evaluate the percentage of subjects who achieved CR or CRi and then proceeded to SCT while in remission prior to Month 6 response assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Remission (DOR) Per Local and IRC Assessment</measure>
    <time_frame>From CR or CRi to relapse or death up to 60 months</time_frame>
    <description>DOR is the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CR or CRi With Minimum Residual Disease (MRD) Negative Bone Marrow 6 Months After CTL019 Infusion</measure>
    <time_frame>within 6 months</time_frame>
    <description>Percentage of participants with best overall response (BOR) of CR or CRi with MRD negative bone marrow status 6 months after CTL019 infusion among all participants who achieved CR or CRi per Local Investigator &amp; IRC assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free Survival (RFS) for Responders Per Local and IRC Assessment</measure>
    <time_frame>60 Months</time_frame>
    <description>RFS is the time from achievement of CR or CRi whichever occurs first to relapse or death due to any cause during CR or CRi.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS) Per Local and IRC Assessment</measure>
    <time_frame>60 Months</time_frame>
    <description>EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure. Treatment failure is defined as &quot;no response&quot; in the study and discontinuation from the study due to any of the following reasons: death, AE, lack of efficacy, new anticancer therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>60 Months</time_frame>
    <description>OS is the time from date of CTL019 infusion to the date of death due to any reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion</measure>
    <time_frame>Day 28</time_frame>
    <description>Percentage of participants attaining CR or CRi with MRD negative bone marrow status at Day 28 +/- 4 days after CTL019 infusion per Local Investigator and IRC assessment. BM MRD were only collected and measured only within responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow</measure>
    <time_frame>Enrollment; D1; D4; D7; D11; D14; D21; D28; M3; M6; M9, M12; M18; M24, M30, M36, M42, M48 for transgene levels in blood; Screening, D28, M3, M6 for transgene levels in bone marrow</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile (levels,persistence, trafficking) of CTL019 cells in target tissues</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)</measure>
    <time_frame>Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36</time_frame>
    <description>Humoral immunogenicity was measured by anti-CTL019 antibodies in human serum using a flow cytometry method. (Prevalence and incidence of immunogenicity to CTL019)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR by Low Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion</measure>
    <time_frame>Within 6 months</time_frame>
    <description>ORR within 6 months after infusion of CTL019 per Local &amp; IRC assessment by baseline bone marrow tumor burden presence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR by High Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion</measure>
    <time_frame>Within 6 months</time_frame>
    <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by high baseline bone marrow tumor burden presence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR by Baseline Extramedullary Disease Presence of Yes Within 6 Months Post CTL019 Infusion</measure>
    <time_frame>Within 6 months</time_frame>
    <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of Yes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR by Baseline Extramedullary Disease Presence of No Within 6 Months Post CTL019 Infusion</measure>
    <time_frame>Within 6 months</time_frame>
    <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of No.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden</measure>
    <time_frame>Within 6 months</time_frame>
    <description>BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion of CTL019 by baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Marrow MRD Status Was by Flow Cytometry Within 6 Months Post CTL019 Infusion by Low Baseline Bone Marrow Tumor Burden</measure>
    <time_frame>Within 6 months</time_frame>
    <description>BM MRD status was per Local Investigator and IRC assessment within 6 months after infusion of CTL019 by low baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: Yes</measure>
    <time_frame>Within 6 months</time_frame>
    <description>BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of Yes. BM MRD were collected and measured only within responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No</measure>
    <time_frame>Within 6 months</time_frame>
    <description>BM MRD status WAS per Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of No. BM MRD were collected and measured only within responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Remission (DoR) Censoring Hematopoietic Stem Cell Transplantation (HSCT) by Low Baseline Bone Marrow Tumor Burden</measure>
    <time_frame>Within 6 months</time_frame>
    <description>DoR per Local Investigator &amp; IRC assessment by low baseline marrow tumor burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Remission (DoR) Censoring HSCT by High Baseline Bone Marrow Tumor Burden</measure>
    <time_frame>Within 6 months</time_frame>
    <description>DoR per Local Investigator &amp; IRC assessment by high baseline bone marrow tumor burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: Yes</measure>
    <time_frame>Within 6 months</time_frame>
    <description>DoR per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of Yes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: No</measure>
    <time_frame>Within 6 months</time_frame>
    <description>DoR per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC</measure>
    <time_frame>Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36</time_frame>
    <description>Activation of T cells in PBMC collected from subjects in response to mCAR19 -derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. CD4 and CD8 T cell net responses (in %) were calculated for 2 non-overlapping CTL019 peptide pools (i.e., Pool 1 and Pool 2). (Lymphocyte subsets of B and T cells and description of associated safety events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: AUC0-28d and AUC0-84d</measure>
    <time_frame>0 - 28 days post-infusion for AUC0-28d and 0 - 84 days post-infusion for AUC0-84d</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. AUC0-28d and AUC0-84d is defined as the AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days). Data was only reported for evaluable PK parameters. The Overall Number of Participants Analyzed represents all participants for which a baseline assessment was collected for this Outcome Measure, and therefore these participants did contribute data to this estimation parameter, whereas the Number Analyzed per Row represents the number of participants with data available at either 28 or 84 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Cmax</measure>
    <time_frame>Day 28</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Cmax is defined as the maximum (peak) observed in peripheral blood drug concentration after single dose administration (% or copies/μg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Tmax</measure>
    <time_frame>Day 28</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Tmax is defined as the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: T1/2</measure>
    <time_frame>Day 28</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. T1/2 is defined as the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve (days) in peripheral blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Clast</measure>
    <time_frame>Day 28</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Clast is defined as the last observed quantifiable concentration in peripheral blood (% or copies/ug)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Tlast</measure>
    <time_frame>Day 28</time_frame>
    <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Tlast is defined as the time of last observed quantifiable concentration in peripheral blood (days)&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed</measure>
    <time_frame>At time of relapse up to 60 months</time_frame>
    <description>The CD19 status of bone marrow/blood relapse was categorized as follows: CD19 positive, CD19 dim, CD19 negative, CD19 positive/negative &amp; CD19 unknown</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed</measure>
    <time_frame>At time of relapse up to 60 months</time_frame>
    <description>This is the site of involvement of initial relapse after achieving a best overall response of CR/CRi.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to B-cell Recovery in Participants Who Achieved CR or CRi by IRC</measure>
    <time_frame>during the whole study, up to 60 months</time_frame>
    <description>Time to B cell recovery was defined as the time from onset of remission to the earliest time when the percentage of CD19+ total B cell among viable WBC is ≥ 1% or among lymphocyte is at least 3%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment</measure>
    <time_frame>Enrollment/Pre-Chemotherapy; Pre-infusion; Baseline; Day 7; Day 14; Day 21; Day 28; Month 3; Month 6; Month 9; Month 12; Month 24; Month 36</time_frame>
    <description>The levels (%) of CD19+ total B cells amongst viable white blood cells (WBC) in peripheral blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)</measure>
    <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
    <description>C-Reactive Protein at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin</measure>
    <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
    <description>Ferritin at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma</measure>
    <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
    <description>INF-gamma at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)</measure>
    <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
    <description>IL-6 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)</measure>
    <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
    <description>IL-2 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>B-cell Acute Lymphoblastic Leukemia</condition>
  <condition>Relapsed B-cell Acute Lymphoblastic Leukemia</condition>
  <condition>Refractory B-cell Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>tisagenlecleucel (CTL019)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pediatric patients with relapsed/refractory B-cell ALL</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CTL019 T-cells</intervention_name>
    <description>A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients &gt; 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients &gt; 50 kg).</description>
    <arm_group_label>tisagenlecleucel (CTL019)</arm_group_label>
    <other_name>tisagenlecleucel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsed or refractory pediatric B-cell ALL and lymphoblastic lymphoma:&#xD;
&#xD;
               1. 2nd or greater Bone Marrow (BM) relapse OR&#xD;
&#xD;
               2. Any BM relapse after allogeneic SCT and must be &gt; 6 months from SCT at the time&#xD;
                  of CTL019 infusion OR&#xD;
&#xD;
               3. Refractory as defined by not achieving a CR after 2 cycles of a standard&#xD;
                  chemotherapy regimen chemotherapy regimen or chemorefractory as defined by not&#xD;
                  achieving a CR after 1 cycle of standard chemotherapy for relapse leukemia OR&#xD;
&#xD;
               4. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are&#xD;
                  intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI),&#xD;
                  or if TKI therapy is contraindicated OR&#xD;
&#xD;
               5. Ineligible for allogeneic SCT&#xD;
&#xD;
          -  For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral&#xD;
             blood by flow cytometry within 3 months of study entry&#xD;
&#xD;
          -  Adequate organ function defined as:&#xD;
&#xD;
               1. Renal function defined as (Calculated creatinine clearance or radioisotope&#xD;
                  Glomerular Filtration Rate (GFR) &gt; 60 mL/min/1.73 m2 OR serum creatinine based on&#xD;
                  age/gender&#xD;
&#xD;
               2. Alanine Aminotransferase (ALT) &lt;= 5 times the upper limit of normal (ULN) for&#xD;
                  age;&#xD;
&#xD;
               3. Bilirubin &lt; 2.0 mg/dL;&#xD;
&#xD;
               4. Must have a minimum level of pulmonary reserve defined as ≤Grade 1 dyspnea and&#xD;
                  pulse oxygenation &gt; 91% on room air&#xD;
&#xD;
               5. Left Ventricular Shortening Fraction (LVSF) ≥ 28% confirmed by echocardiogram, or&#xD;
                  Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or&#xD;
                  MUGA within 7 days of screening&#xD;
&#xD;
          -  Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening&#xD;
&#xD;
          -  Life expectancy &gt; 12 weeks&#xD;
&#xD;
          -  Age 3 at the time of screening per protocol to age 21 at the time of initial diagnosis&#xD;
&#xD;
          -  Karnofsky (age ≥ 16 years) or Lansky (age &lt; 16 years) performance status ≥ 50 at&#xD;
             screening&#xD;
&#xD;
          -  Signed written informed consent and assent forms (if applicable) must be obtained&#xD;
             prior to any study procedures&#xD;
&#xD;
          -  Once all other eligibility criteria are confirmed, must have an apheresis product of&#xD;
             non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis&#xD;
             product will not be shipped to or assessed for acceptance by the manufacturing site&#xD;
             until documented confirmation of all other eligibility criteria is received.&#xD;
&#xD;
          -  Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only&#xD;
             are eligible but will have their CTL019 infusion delayed until CNS disease is reduced&#xD;
             to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic&#xD;
             involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or&#xD;
             significant leptomeningeal disease are not eligible. However, such patients with other&#xD;
             forms of CNS-3 leukemic involvement (non-CSF involvement) are eligible if there is&#xD;
             documented evidence of disease stabilization for at least 3 months prior to CTL019&#xD;
             infusion. Patients must have no acute/ongoing neurologic toxicity &gt; Grade 1 with the&#xD;
             exception of a history of controlled seizures or fixed neurologic deficits that have&#xD;
             been stable/improving over the past 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Isolated extra-medullary disease relapse&#xD;
&#xD;
          -  Patients with concomitant genetic syndrome: such as patients with Fanconi anemia,&#xD;
             Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome.&#xD;
             Patients with Down Syndrome will not be excluded.&#xD;
&#xD;
          -  Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL,&#xD;
             leukemia with B-cell [surface Immunoglobulin (sIg) positive and kappa or lambda&#xD;
             restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)&#xD;
&#xD;
          -  Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative&#xD;
             intent and with no evidence of active disease&#xD;
&#xD;
          -  Prior treatment with gene therapy product&#xD;
&#xD;
          -  Treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy&#xD;
&#xD;
          -  Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)&#xD;
&#xD;
          -  Patient has participated in an investigational research study using an investigational&#xD;
             agent within the last 30 days prior to screening&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive&#xD;
             potential must have a negative serum or urine pregnancy test performed within 48 hours&#xD;
             before infusion&#xD;
&#xD;
          -  Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening),&#xD;
             or any uncontrolled infection at screening&#xD;
&#xD;
          -  HIV positive test within 8 weeks of screening&#xD;
&#xD;
          -  The following medications are excluded:&#xD;
&#xD;
               1. Steroids: Therapeutic systemic doses of steroids must be stopped &gt; 72 hours prior&#xD;
                  to CTL019 infusion. However, the following physiological replacement doses of&#xD;
                  steroids are allowed: &lt; 12 mg/m2/day hydrocortisone or equivalent&#xD;
&#xD;
               2. Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be&#xD;
                  completed &gt; 6 weeks prior to CTL019 infusion&#xD;
&#xD;
               3. GVHD therapies: Any systemic drug used for GVHD must be stopped &gt; 4 weeks prior&#xD;
                  to CTL019 infusion to confirm that GVHD recurrence is not observed (e.g.&#xD;
                  calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate,&#xD;
                  rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20&#xD;
                  (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin 6 [anti-IL6]&#xD;
                  or anti-interleukin 6 receptor [anti-IL6R], systemic steroids)&#xD;
&#xD;
               4. Chemotherapy:&#xD;
&#xD;
          -  Tyrosine kinase inhibitors and hydroxyurea must be stopped &gt; 72 hours prior to CTL019&#xD;
             infusion&#xD;
&#xD;
          -  The following drugs must be stopped &gt; 1 week prior to CTL019 infusion and should not&#xD;
             be administered concomitantly or following lymphodepleting chemotherapy: vincristine,&#xD;
             6-mercaptopurine, 6-thioguanine, methotrexate &lt; 25 mg/m2, cytosine arabinoside &lt; 100&#xD;
             mg/m2/day, asparaginase (non-pegylated)&#xD;
&#xD;
          -  The following drugs must be stopped &gt;2 weeks prior to CTL019 infusion: salvage&#xD;
             chemotherapy (e.g. clofarabine, cytosine arabinoside &gt; 100 mg/m2, anthracyclines,&#xD;
             cyclophosphamide, methotrexate ≥ 25 mg/m2), excluding the required lymphodepleting&#xD;
             chemotherapy drugs&#xD;
&#xD;
          -  Pegylated-asparaginase must be stopped &gt; 4 weeks prior to CTL019 infusion e. CNS&#xD;
             disease prophylaxis:&#xD;
&#xD;
          -  CNS prophylaxis treatment must be stopped &gt; 1 week prior to CTL019 infusion (e.g.&#xD;
             intrathecal methotrexate) f. Radiotherapy:&#xD;
&#xD;
          -  Non-CNS site of radiation must be completed &gt; 2 weeks prior to CTL019 infusion&#xD;
&#xD;
          -  CNS directed radiation must be completed &gt; 8 weeks prior to CTL019 infusion g. Anti&#xD;
             T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g.&#xD;
             alemtuzumab) within 8 weeks prior to CTL019 is prohibited since residual lytic levels&#xD;
             may destroy the infused CTL019 cells and/or prevent their in vivo expansion. If such&#xD;
             an agent has been administered within 8 weeks prior to CTL019, contact the Sponsor,&#xD;
             consider consultation with an pharmacology expert, and consider measuring residual&#xD;
             drug levels, if feasible, prior to CTL019 infusion Women of child-bearing potential&#xD;
             (defined as all women physiologically capable of becoming pregnant) and all male&#xD;
             participants, unless they are using highly effective methods of contraception for a&#xD;
             period of 1 year after the CTL019 infusion. Highly effective contraception methods&#xD;
             include:&#xD;
&#xD;
               1. Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods) and withdrawal are NOT acceptable methods of&#xD;
                  contraception&#xD;
&#xD;
               2. Female sterilization (have had surgical bilateral oophorectomy with or without&#xD;
                  hysterectomy), total hysterectomy, or tubal ligation at least six weeks before&#xD;
                  taking study treatment. In case of oophorectomy alone, only when the reproductive&#xD;
                  status of the woman has been confirmed by follow up hormone level assessment&#xD;
&#xD;
               3. Male sterilization (at least 6 months prior to screening). For female patients on&#xD;
                  the study the vasectomized male partner should be the sole partner for that&#xD;
                  patient&#xD;
&#xD;
               4. Use of oral, injected or implanted hormonal methods of contraception or other&#xD;
                  forms of hormonal contraception that have comparable efficacy (failure rate &lt;1%),&#xD;
                  for example hormone vaginal ring or transdermal hormone contraception&#xD;
&#xD;
               5. Use of IUDs are excluded due to increased risks of infection and bleeding in this&#xD;
                  population. However, IUD inserted prior to consent may remain in place, and a&#xD;
                  second method of contraception is mandated&#xD;
&#xD;
               6. In case of use of oral contraception, women must be stable on the same pill for a&#xD;
                  minimum of 3 months before taking study treatment.&#xD;
&#xD;
        Women who are not of reproductive potential (defined as either &lt;11 years of age, Tanner&#xD;
        Stage 1, post-menopausal for at least 24 consecutive months (i.e. have had no menses) or&#xD;
        have undergone hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) are&#xD;
        eligible without requiring the use of contraception. Women who are not yet of reproductive&#xD;
        potential are to agree to use acceptable forms of contraception when they reach&#xD;
        reproductive potential if within 1 year of CTL019 or if CAR cells are present in the blood&#xD;
        by PCR. Acceptable documentation includes written or oral documentation communicated by&#xD;
        clinician or clinician's staff of one of the following:&#xD;
&#xD;
          1. Demographics show age &lt; 11&#xD;
&#xD;
          2. Physical examination indicates Tanner Stage 1&#xD;
&#xD;
          3. Physician report/letter&#xD;
&#xD;
          4. Operative report or other source documentation in the patient record&#xD;
&#xD;
          5. Discharge summary&#xD;
&#xD;
          6. Follicle stimulating hormone measurement elevated into the menopausal range&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Childrens Hospital Los Angeles SC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta SC-2</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5941</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Children's Kansas University</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University SC</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center SC</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>November 22, 2019</results_first_submitted>
  <results_first_submitted_qc>October 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 23, 2020</results_first_posted>
  <disposition_first_submitted>May 13, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>May 23, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 3, 2019</disposition_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>relapsed/refractory</keyword>
  <keyword>Philadelphia chromosome positive acute lymphoblastic leukemia</keyword>
  <keyword>Pharmaceuticals</keyword>
  <keyword>Philadelphia chromosome positive</keyword>
  <keyword>Acute Lymphoid Leukemia (ALL)</keyword>
  <keyword>Acute Lymphocytic Leukemia (ALL)</keyword>
  <keyword>CTL019</keyword>
  <keyword>tisagenlecleucel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tisagenlecleucel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
    <ipd_url>http://www.clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02228096/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02228096/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited between 14-Aug-2014 (FPFV) and 22-Sep-2017 (LPFV). At the time of LPLV (24-May-2019), the sponsor had decided to transfer all ongoing patients to a separate long-term follow-up study to complete the planned 15 years of follow-up. These patients are designated with the reason for discontinuation as &quot;terminated by sponsor&quot;.</recruitment_details>
      <pre_assignment_details>&quot;Enrolled&quot; means all eligibility criteria were met and apheresis was accepted by the manufacturing facility. Patients could discontinue the trial after enrollment and prior to tisagenlecleucel infusion. Although 75 patients were enrolled, only 64 were infused as 11 discontinued prior to infusion.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tisagenlecleucel (CTL019) - All Participants</title>
          <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Enrolled Into Long-term f/u Protocol</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Enrolled But Not Infused</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Enrolled and Infused</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4">Completed = study follow-up completed</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject/guardian decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>New therapy for study indication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled, not infused</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled Set: All participants who met all the inclusion/exclusion criteria, and whose apheresis product is received and accepted by the manufacturing facilty</population>
      <group_list>
        <group group_id="B1">
          <title>Tisagenlecleucel (CTL019) - All Participants</title>
          <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel</description>
        </group>
        <group group_id="B2">
          <title>Not Infused</title>
          <description>Pediatric patients with r/r B-cell who were enrolled in the study but not infused with tisagenlecleucel</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="64"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.4" spread="5.16"/>
                    <measurement group_id="B2" value="15.2" spread="5.44"/>
                    <measurement group_id="B3" value="12.8" spread="5.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.7" spread="20.10"/>
                    <measurement group_id="B2" value="86.2" spread="41.52"/>
                    <measurement group_id="B3" value="47.3" spread="25.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Karnofsky/Lansky performance status</title>
          <description>Karnofsky/Lansky performance status helps determine the functional status of a recipient. This status is a critical data field that has been determined to be essential for all outcome-based analyses. Karnofsky Scale: designed for recipients aged 16 years &amp; older; Lansky Scale: designed for recipients 1 year old to less than 16 years old. The Karnofsky/Lansky performances are based from 100 to 0, where 100 is &quot;perfect&quot; health &amp; 0 is death. The scale: Able to carry on normal activity, no special care needed (80- 100); Mild to moderate restriction (50-70); Moderate to severe restriction (10- 40).</description>
          <population>FAS = All subjects who received an infusion of tisagenlecleucel</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>less than 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="64"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)</title>
        <description>ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.</description>
        <time_frame>within 6 months after CTL019 infusion</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - All Participants</title>
            <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)</title>
          <description>ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.3" lower_limit="57.6" upper_limit="81.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Clopper-Pearson</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Remission Rate (ORR) Per Local Investigator Assessment (for Lymphoblastic Lymphoma Patients Only)</title>
        <description>Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and cerebrospinal fluid (CSF). This primary endpoint was based on the local investigator assessment. No participants with lymphoblastic lymphoma were infused in this study.</description>
        <time_frame>6 months after CTL019</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS. No patients with Lymphoblastic Lymphoma were enrolled in this trial, hence there is no data to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Remission Rate (ORR) Per Local Investigator Assessment (for Lymphoblastic Lymphoma Patients Only)</title>
          <description>Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and cerebrospinal fluid (CSF). This primary endpoint was based on the local investigator assessment. No participants with lymphoblastic lymphoma were infused in this study.</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS. No patients with Lymphoblastic Lymphoma were enrolled in this trial, hence there is no data to report.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment</title>
        <description>Evaluate the percentage of participants who achieved CR or CRi at Month 6 without SCT between tisagenlecleucel infusion and Month 6 response assessment.</description>
        <time_frame>Month 6</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment</title>
          <description>Evaluate the percentage of participants who achieved CR or CRi at Month 6 without SCT between tisagenlecleucel infusion and Month 6 response assessment.</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1" lower_limit="40.2" upper_limit="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Achieved CR or CRi and Then Proceeded to SCT While in Remission Prior to Month 6 Response - Per IRC Assessment</title>
        <description>Evaluate the percentage of subjects who achieved CR or CRi and then proceeded to SCT while in remission prior to Month 6 response assessment.</description>
        <time_frame>prior to Month 6</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Per IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Achieved CR or CRi and Then Proceeded to SCT While in Remission Prior to Month 6 Response - Per IRC Assessment</title>
          <description>Evaluate the percentage of subjects who achieved CR or CRi and then proceeded to SCT while in remission prior to Month 6 response assessment.</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" lower_limit="2.6" upper_limit="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Remission (DOR) Per Local and IRC Assessment</title>
        <description>DOR is the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL</description>
        <time_frame>From CR or CRi to relapse or death up to 60 months</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Remission (DOR) Per Local and IRC Assessment</title>
          <description>DOR is the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="13.6" upper_limit="NA">N/A = median DOR was not reached as there were not enough participants with DOR events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="13.6" upper_limit="NA">N/A = median DOR was not reached as there were not enough participants with DOR events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CR or CRi With Minimum Residual Disease (MRD) Negative Bone Marrow 6 Months After CTL019 Infusion</title>
        <description>Percentage of participants with best overall response (BOR) of CR or CRi with MRD negative bone marrow status 6 months after CTL019 infusion among all participants who achieved CR or CRi per Local Investigator &amp; IRC assessment</description>
        <time_frame>within 6 months</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CR or CRi With Minimum Residual Disease (MRD) Negative Bone Marrow 6 Months After CTL019 Infusion</title>
          <description>Percentage of participants with best overall response (BOR) of CR or CRi with MRD negative bone marrow status 6 months after CTL019 infusion among all participants who achieved CR or CRi per Local Investigator &amp; IRC assessment</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.2" lower_limit="54.3" upper_limit="78.4"/>
                    <measurement group_id="O2" value="67.2" lower_limit="54.3" upper_limit="78.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relapse-free Survival (RFS) for Responders Per Local and IRC Assessment</title>
        <description>RFS is the time from achievement of CR or CRi whichever occurs first to relapse or death due to any cause during CR or CRi.</description>
        <time_frame>60 Months</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Relapse-free Survival (RFS) for Responders Per Local and IRC Assessment</title>
          <description>RFS is the time from achievement of CR or CRi whichever occurs first to relapse or death due to any cause during CR or CRi.</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="13.6" upper_limit="NA">N/A = median RFS was not reached as there were not enough participants with RFS events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="13.6" upper_limit="NA">N/A = median RFS was not reached as there were not enough participants with RFS events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event-free Survival (EFS) Per Local and IRC Assessment</title>
        <description>EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure. Treatment failure is defined as &quot;no response&quot; in the study and discontinuation from the study due to any of the following reasons: death, AE, lack of efficacy, new anticancer therapy.</description>
        <time_frame>60 Months</time_frame>
        <population>FAS: All subjects who received an infusion of CTL019</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Event-free Survival (EFS) Per Local and IRC Assessment</title>
          <description>EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure. Treatment failure is defined as &quot;no response&quot; in the study and discontinuation from the study due to any of the following reasons: death, AE, lack of efficacy, new anticancer therapy.</description>
          <population>FAS: All subjects who received an infusion of CTL019</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" lower_limit="6.4" upper_limit="NA">N/A = not estimable because there were not enough participants who had an EFS event to estimate the upper limit of the median EFS</measurement>
                    <measurement group_id="O2" value="15.6" lower_limit="6.4" upper_limit="NA">N/A = not estimable because there were not enough participants who had an EFS event to estimate the upper limit of the median EFS</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is the time from date of CTL019 infusion to the date of death due to any reason</description>
        <time_frame>60 Months</time_frame>
        <population>FAS: All subjects who received an infusion of CTL019</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - All Participants</title>
            <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is the time from date of CTL019 infusion to the date of death due to any reason</description>
          <population>FAS: All subjects who received an infusion of CTL019</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.9" lower_limit="15.1" upper_limit="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion</title>
        <description>Percentage of participants attaining CR or CRi with MRD negative bone marrow status at Day 28 +/- 4 days after CTL019 infusion per Local Investigator and IRC assessment. BM MRD were only collected and measured only within responders.</description>
        <time_frame>Day 28</time_frame>
        <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS. BM MRD were only collected and measured only within responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion</title>
          <description>Percentage of participants attaining CR or CRi with MRD negative bone marrow status at Day 28 +/- 4 days after CTL019 infusion per Local Investigator and IRC assessment. BM MRD were only collected and measured only within responders.</description>
          <population>Efficacy Analysis Set (EAS): A subset of all infused patients who were treated with CTL019 at least 6 months prior to the clinical data cutoff. In the final analysis, it is identical to the FAS. BM MRD were only collected and measured only within responders.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>With BM MRD -ve: i.e. MRD% &lt; 0.01%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9" lower_limit="59.2" upper_limit="82.4"/>
                    <measurement group_id="O2" value="71.9" lower_limit="59.2" upper_limit="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With BM 0.01% &lt;= MRD% &lt; 5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="NA" upper_limit="NA">N/A: only 1 participant with BM MRD to calculate meaningful confidence interval (CI)</measurement>
                    <measurement group_id="O2" value="1.6" lower_limit="NA" upper_limit="NA">N/A: only 1 participant with BM MRD to calculate meaningful confidence interval (CI)</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With BM MRD% &gt;= 5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="NA" upper_limit="NA">N/A: only 1 participant with BM MRD to calculate meaningful CI</measurement>
                    <measurement group_id="O2" value="1.6" lower_limit="NA" upper_limit="NA">N/A: only 1 participant with BM MRD to calculate meaningful CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BM MRD not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="NA" upper_limit="NA">N/A: few participants with BM MRD to provide meaningful CI</measurement>
                    <measurement group_id="O2" value="6.3" lower_limit="NA" upper_limit="NA">N/A: few participants with BM MRD to provide meaningful CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile (levels,persistence, trafficking) of CTL019 cells in target tissues</description>
        <time_frame>Enrollment; D1; D4; D7; D11; D14; D21; D28; M3; M6; M9, M12; M18; M24, M30, M36, M42, M48 for transgene levels in blood; Screening, D28, M3, M6 for transgene levels in bone marrow</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile (levels,persistence, trafficking) of CTL019 cells in target tissues</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
          <units>copies/ug DNA</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Enrollment blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">N/A: No CTL019 was infused at the enrollment</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">N/A: No CTL019 was infused at the enrollment</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">N/A: No CTL019 was infused at the enrollment</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (D1): blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3680" spread="344.3"/>
                    <measurement group_id="O2" value="3190" spread="348.6"/>
                    <measurement group_id="O3" value="2440" spread="220.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D4: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="234" spread="197.8"/>
                    <measurement group_id="O2" value="48.8" spread="282.4"/>
                    <measurement group_id="O3" value="88.0" spread="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D7: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4460" spread="616.2"/>
                    <measurement group_id="O2" value="231" spread="499.1"/>
                    <measurement group_id="O3" value="402" spread="114.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D11: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21200" spread="262.3"/>
                    <measurement group_id="O2" value="423" spread="52.7"/>
                    <measurement group_id="O3" value="1920" spread="8318.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D14: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12500" spread="292.1"/>
                    <measurement group_id="O2" value="1600" spread="337.1"/>
                    <measurement group_id="O3" value="42835.8" spread="9060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D21: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3720" spread="480.5"/>
                    <measurement group_id="O2" value="7750" spread="334.5"/>
                    <measurement group_id="O3" value="1050" spread="220743.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D28: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1360" spread="650.3"/>
                    <measurement group_id="O2" value="2770" spread="684.8"/>
                    <measurement group_id="O3" value="515" spread="244650713.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 (M3): blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220" spread="224.3"/>
                    <measurement group_id="O2" value="690" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV</measurement>
                    <measurement group_id="O3" value="564" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M6: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146" spread="157.5"/>
                    <measurement group_id="O2" value="NA" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV; also, the geometric mean was not applicable for NR group at Month 6 as the arithmetic mean was zero</measurement>
                    <measurement group_id="O3" value="127" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M9: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117" spread="179.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M12: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113" spread="312.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M18: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2" spread="200.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M24: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" spread="160.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M30: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.9" spread="150.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M36: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M42: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month M48: blood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA = geometric mean is not estimable because the CTL019 transgene level for the only one patient is 0.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening: Bone marrow (BM)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">N/A = No CTL019 was infused at screening</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">N/A = No CTL019 was infused at screening</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">N/A = No CTL019 was infused at screening</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D28 BM</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="646" spread="1009.7"/>
                    <measurement group_id="O2" value="969" spread="166.8"/>
                    <measurement group_id="O3" value="615" spread="4763885.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3 BM</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179" spread="182.5"/>
                    <measurement group_id="O3" value="542" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6 BM</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133" spread="121.7"/>
                    <measurement group_id="O2" value="35.3" spread="NA">N/A = not estimable because too few participants to calculate Geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)</title>
        <description>Humoral immunogenicity was measured by anti-CTL019 antibodies in human serum using a flow cytometry method. (Prevalence and incidence of immunogenicity to CTL019)</description>
        <time_frame>Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)</title>
          <description>Humoral immunogenicity was measured by anti-CTL019 antibodies in human serum using a flow cytometry method. (Prevalence and incidence of immunogenicity to CTL019)</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="83.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="83.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.8"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ORR by Low Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion</title>
        <description>ORR within 6 months after infusion of CTL019 per Local &amp; IRC assessment by baseline bone marrow tumor burden presence.</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 12 having a low bone marrow tumor burden at enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>ORR by Low Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion</title>
          <description>ORR within 6 months after infusion of CTL019 per Local &amp; IRC assessment by baseline bone marrow tumor burden presence.</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 12 having a low bone marrow tumor burden at enrollment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" lower_limit="51.6" upper_limit="97.9"/>
                    <measurement group_id="O2" value="83.3" lower_limit="51.6" upper_limit="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ORR by High Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion</title>
        <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by high baseline bone marrow tumor burden presence.</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high bone marrow tumor burden at enrollment</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>ORR by High Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion</title>
          <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by high baseline bone marrow tumor burden presence.</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high bone marrow tumor burden at enrollment</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.3" lower_limit="43.9" upper_limit="80.1"/>
                    <measurement group_id="O2" value="63.3" lower_limit="43.9" upper_limit="80.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ORR by Baseline Extramedullary Disease Presence of Yes Within 6 Months Post CTL019 Infusion</title>
        <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of Yes.</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 2 participants having a baseline extramedullary presence.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>ORR by Baseline Extramedullary Disease Presence of Yes Within 6 Months Post CTL019 Infusion</title>
          <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of Yes.</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 2 participants having a baseline extramedullary presence.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="NA" upper_limit="NA">N/A: no confidence interval for 100% response</measurement>
                    <measurement group_id="O2" value="100" lower_limit="NA" upper_limit="NA">N/A: no confidence interval for 100% response</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ORR by Baseline Extramedullary Disease Presence of No Within 6 Months Post CTL019 Infusion</title>
        <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of No.</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 40 participants having no baseline extramedullary presence.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>ORR by Baseline Extramedullary Disease Presence of No Within 6 Months Post CTL019 Infusion</title>
          <description>ORR within 6 months after infusion of CTL019 per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of No.</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 40 participants having no baseline extramedullary presence.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" lower_limit="50.9" upper_limit="81.4"/>
                    <measurement group_id="O2" value="67.5" lower_limit="50.9" upper_limit="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden</title>
        <description>BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion of CTL019 by baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.</description>
        <time_frame>Within 6 months</time_frame>
        <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high baseline bone marrow tumor burden. BM MRD were collected and measured only within responders</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden</title>
          <description>BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion of CTL019 by baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.</description>
          <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high baseline bone marrow tumor burden. BM MRD were collected and measured only within responders</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Had BOR of CR/CRi with BM MRD -ve (MRD%&lt; 0.01%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.7" lower_limit="37.4" upper_limit="74.5"/>
                    <measurement group_id="O2" value="56.7" lower_limit="37.4" upper_limit="74.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had BOR of CR/CRi with BM 0.01% &lt;= MRD% &lt; 5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="NA" upper_limit="NA">N/A = too few participants to calculate a meaningful CI</measurement>
                    <measurement group_id="O2" value="6.7" lower_limit="NA" upper_limit="NA">N/A = too few participants to calculate a meaningful CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone Marrow MRD Status Was by Flow Cytometry Within 6 Months Post CTL019 Infusion by Low Baseline Bone Marrow Tumor Burden</title>
        <description>BM MRD status was per Local Investigator and IRC assessment within 6 months after infusion of CTL019 by low baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.</description>
        <time_frame>Within 6 months</time_frame>
        <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants and 12 having a high baseline bone marrow tumor burden. BM MRD were collected and measured only within responders</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Marrow MRD Status Was by Flow Cytometry Within 6 Months Post CTL019 Infusion by Low Baseline Bone Marrow Tumor Burden</title>
          <description>BM MRD status was per Local Investigator and IRC assessment within 6 months after infusion of CTL019 by low baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.</description>
          <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants and 12 having a high baseline bone marrow tumor burden. BM MRD were collected and measured only within responders</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" lower_limit="51.6" upper_limit="97.9"/>
                    <measurement group_id="O2" value="83.3" lower_limit="51.6" upper_limit="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: Yes</title>
        <description>BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of Yes. BM MRD were collected and measured only within responders.</description>
        <time_frame>Within 6 months</time_frame>
        <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff. FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants &amp; 2 having a BL extramedullary disease presence of Yes. BM MRD were collected &amp; measured only within responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: Yes</title>
          <description>BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of Yes. BM MRD were collected and measured only within responders.</description>
          <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff. FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants &amp; 2 having a BL extramedullary disease presence of Yes. BM MRD were collected &amp; measured only within responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="15.8" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="15.8" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No</title>
        <description>BM MRD status WAS per Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of No. BM MRD were collected and measured only within responders.</description>
        <time_frame>Within 6 months</time_frame>
        <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff. FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants &amp; 40 having a BL extramedullary disease presence of No. BM MRD were collected &amp; measured only within responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No</title>
          <description>BM MRD status WAS per Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of No. BM MRD were collected and measured only within responders.</description>
          <population>Efficacy Analysis Set: A subset of FAS treated with CTL019 at least 6 months prior to the clinical data cutoff. FAS: All subjects who received an infusion of CTL019. Data is based on cut-off date of 6-Oct-2017, with only 42 participants &amp; 40 having a BL extramedullary disease presence of No. BM MRD were collected &amp; measured only within responders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>With BM MRD -ve (MRD%&lt; 0.01%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" lower_limit="45.8" upper_limit="77.3"/>
                    <measurement group_id="O2" value="62.5" lower_limit="45.8" upper_limit="77.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With bone marrow 0.01% &lt;= MRD% &lt; 5%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="NA" upper_limit="NA">N/A = too few participants to calculate CI</measurement>
                    <measurement group_id="O2" value="5.0" lower_limit="NA" upper_limit="NA">N/A = too few participants to calculate CI</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Remission (DoR) Censoring Hematopoietic Stem Cell Transplantation (HSCT) by Low Baseline Bone Marrow Tumor Burden</title>
        <description>DoR per Local Investigator &amp; IRC assessment by low baseline marrow tumor burden</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 12 having a low baseline marrow tumor burden</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Remission (DoR) Censoring Hematopoietic Stem Cell Transplantation (HSCT) by Low Baseline Bone Marrow Tumor Burden</title>
          <description>DoR per Local Investigator &amp; IRC assessment by low baseline marrow tumor burden</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 12 having a low baseline marrow tumor burden</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.4" upper_limit="NA">N/A = median DoR was not reached as there were not enough participants with DoR events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="5.4" upper_limit="NA">N/A = median DoR was not reached as there were not enough participants with DoR events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Remission (DoR) Censoring HSCT by High Baseline Bone Marrow Tumor Burden</title>
        <description>DoR per Local Investigator &amp; IRC assessment by high baseline bone marrow tumor burden</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high baseline marrow tumor burden</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Remission (DoR) Censoring HSCT by High Baseline Bone Marrow Tumor Burden</title>
          <description>DoR per Local Investigator &amp; IRC assessment by high baseline bone marrow tumor burden</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 30 having a high baseline marrow tumor burden</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.3" upper_limit="NA">N/A = median DoR was not reached as there were not enough participants with DoR events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="5.3" upper_limit="NA">N/A = median DoR was not reached as there were not enough participants with DoR events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: Yes</title>
        <description>DoR per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of Yes.</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 2 having a baseline extramedullary disease presence of Yes</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: Yes</title>
          <description>DoR per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of Yes.</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 2 having a baseline extramedullary disease presence of Yes</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="3.4" upper_limit="NA">N/A = median DoR was not reached as there were not enough participants with D0R events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="3.4" upper_limit="NA">N/A = median DoR was not reached as there were not enough participants with DoR events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: No</title>
        <description>DoR per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of No</description>
        <time_frame>Within 6 months</time_frame>
        <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 40 having a baseline extramedullary disease presence of No</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - Local Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
          <group group_id="O2">
            <title>Tisagenlecleucel (CTL019) - IRC Assessment</title>
            <description>Pediatric participants with r/r B-cell ALL</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: No</title>
          <description>DoR per Local Investigator &amp; IRC assessment by baseline extramedullary disease presence of No</description>
          <population>EAS: Efficacy Analysis Set (EAS): A subset of full analysis set (FAS) who were treated with CTL019 at least 6 months prior to the clinical data cutoff FAS: All subjects who received an infusion of CTL019. Data is based on data cut-off date of 6-Oct-2017, with only 42 participants and 40 having a baseline extramedullary disease presence of No</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.9" upper_limit="NA">N/A = median DOR was not reached as there were not enough participants with DOR events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="5.9" upper_limit="NA">N/A = median DOR was not reached as there were not enough participants with DOR events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC</title>
        <description>Activation of T cells in PBMC collected from subjects in response to mCAR19 -derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. CD4 and CD8 T cell net responses (in %) were calculated for 2 non-overlapping CTL019 peptide pools (i.e., Pool 1 and Pool 2). (Lymphocyte subsets of B and T cells and description of associated safety events)</description>
        <time_frame>Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC</title>
          <description>Activation of T cells in PBMC collected from subjects in response to mCAR19 -derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. CD4 and CD8 T cell net responses (in %) were calculated for 2 non-overlapping CTL019 peptide pools (i.e., Pool 1 and Pool 2). (Lymphocyte subsets of B and T cells and description of associated safety events)</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36: Pool 1 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Pool 2 CD3+ CD4+ IFNg+ )</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36: Pool 2 CD3+ CD4+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36: Pool 1 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3"/>
                    <measurement group_id="O2" value="83.3"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3"/>
                    <measurement group_id="O2" value="16.7"/>
                    <measurement group_id="O3" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36: Pool 2 CD3+ CD8+ IFNg+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: AUC0-28d and AUC0-84d</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. AUC0-28d and AUC0-84d is defined as the AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days). Data was only reported for evaluable PK parameters. The Overall Number of Participants Analyzed represents all participants for which a baseline assessment was collected for this Outcome Measure, and therefore these participants did contribute data to this estimation parameter, whereas the Number Analyzed per Row represents the number of participants with data available at either 28 or 84 days.</description>
        <time_frame>0 - 28 days post-infusion for AUC0-28d and 0 - 84 days post-infusion for AUC0-84d</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data.</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: AUC0-28d and AUC0-84d</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. AUC0-28d and AUC0-84d is defined as the AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days). Data was only reported for evaluable PK parameters. The Overall Number of Participants Analyzed represents all participants for which a baseline assessment was collected for this Outcome Measure, and therefore these participants did contribute data to this estimation parameter, whereas the Number Analyzed per Row represents the number of participants with data available at either 28 or 84 days.</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data.</population>
          <units>copies/µg*days</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC0-28d</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261000" spread="199.8"/>
                    <measurement group_id="O2" value="151000" spread="71.7"/>
                    <measurement group_id="O3" value="617000" spread="NA">N/A = Too few participants to calculate geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC0-84d</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="368000" spread="182.9"/>
                    <measurement group_id="O2" value="443000" spread="79.9"/>
                    <measurement group_id="O3" value="1340000" spread="NA">N/A = Too few participants to calculate geometric CV</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Cmax</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Cmax is defined as the maximum (peak) observed in peripheral blood drug concentration after single dose administration (% or copies/μg).</description>
        <time_frame>Day 28</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Cmax</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Cmax is defined as the maximum (peak) observed in peripheral blood drug concentration after single dose administration (% or copies/μg).</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
          <units>copies/µg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28300" spread="197.0"/>
                    <measurement group_id="O2" value="15100" spread="49.4"/>
                    <measurement group_id="O3" value="52500" spread="91.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Tmax</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Tmax is defined as the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)</description>
        <time_frame>Day 28</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Tmax</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Tmax is defined as the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.84" lower_limit="6.74" upper_limit="54.8"/>
                    <measurement group_id="O2" value="20.0" lower_limit="13.9" upper_limit="22.8"/>
                    <measurement group_id="O3" value="11.9" lower_limit="11.0" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: T1/2</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. T1/2 is defined as the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve (days) in peripheral blood</description>
        <time_frame>Day 28</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: T1/2</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. T1/2 is defined as the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve (days) in peripheral blood</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
          <units>days</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="415.1"/>
                    <measurement group_id="O2" value="4.36" spread="421.2"/>
                    <measurement group_id="O3" value="42.1" spread="NA">N/A = with only 1 subject, geometric CV could not be calculated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Clast</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Clast is defined as the last observed quantifiable concentration in peripheral blood (% or copies/ug)</description>
        <time_frame>Day 28</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Clast</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Clast is defined as the last observed quantifiable concentration in peripheral blood (% or copies/ug)</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
          <units>copies/µg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="223" spread="283.4"/>
                    <measurement group_id="O2" value="1980" spread="207.5"/>
                    <measurement group_id="O3" value="80.3" spread="NA">N/A = with only 1 subject, geometric CV could not be calculated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Tlast</title>
        <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Tlast is defined as the time of last observed quantifiable concentration in peripheral blood (days)&quot;</description>
        <time_frame>Day 28</time_frame>
        <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response (NR)</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local &amp; IRC Assessment: Tlast</title>
          <description>Characterize the in vivo cellular pharmacokinetic (PK) profile. Tlast is defined as the time of last observed quantifiable concentration in peripheral blood (days)&quot;</description>
          <population>Pharmacokinetic Analysis Set (PAS): A subset of FAS who have at least one sample providing evaluable pharmacokinetic (PK) data</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179" lower_limit="17.8" upper_limit="921"/>
                    <measurement group_id="O2" value="26.9" lower_limit="26.7" upper_limit="96.1"/>
                    <measurement group_id="O3" value="210" lower_limit="210" upper_limit="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed</title>
        <description>The CD19 status of bone marrow/blood relapse was categorized as follows: CD19 positive, CD19 dim, CD19 negative, CD19 positive/negative &amp; CD19 unknown</description>
        <time_frame>At time of relapse up to 60 months</time_frame>
        <population>FAS patients who achieved CR &amp; CRi and then relapsed. FAS: All subjects who received an infusion of CTL019</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel - FAS Pts Who Achieved CR/CRi &amp; Then Relapsed</title>
            <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel and then relapsed</description>
          </group>
        </group_list>
        <measure>
          <title>CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed</title>
          <description>The CD19 status of bone marrow/blood relapse was categorized as follows: CD19 positive, CD19 dim, CD19 negative, CD19 positive/negative &amp; CD19 unknown</description>
          <population>FAS patients who achieved CR &amp; CRi and then relapsed. FAS: All subjects who received an infusion of CTL019</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD19 status of BM/blood relapse:positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD19 status of BM/blood relapse: dim</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD19 status of BM/blood relapse: negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD19 status of BM/blood relapse: +ve/-ve</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD19 status of BM/blood relapse: Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed</title>
        <description>This is the site of involvement of initial relapse after achieving a best overall response of CR/CRi.</description>
        <time_frame>At time of relapse up to 60 months</time_frame>
        <population>FAS patients who achieved CR &amp; CRi and then relapsed. FAS: All subjects who received an infusion of CTL019</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel - FAS Pts Who Achieved CR/CRi &amp; Then Relapsed</title>
            <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel and then relapsed</description>
          </group>
        </group_list>
        <measure>
          <title>Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed</title>
          <description>This is the site of involvement of initial relapse after achieving a best overall response of CR/CRi.</description>
          <population>FAS patients who achieved CR &amp; CRi and then relapsed. FAS: All subjects who received an infusion of CTL019</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BM/blood relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extramedullary only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to B-cell Recovery in Participants Who Achieved CR or CRi by IRC</title>
        <description>Time to B cell recovery was defined as the time from onset of remission to the earliest time when the percentage of CD19+ total B cell among viable WBC is ≥ 1% or among lymphocyte is at least 3%.</description>
        <time_frame>during the whole study, up to 60 months</time_frame>
        <population>FAS patients who achieved CR or CRi. FAS: All subjects who received an infusion of CTL019</population>
        <group_list>
          <group group_id="O1">
            <title>Tisagenlecleucel (CTL019) - All Participants</title>
            <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel</description>
          </group>
        </group_list>
        <measure>
          <title>Time to B-cell Recovery in Participants Who Achieved CR or CRi by IRC</title>
          <description>Time to B cell recovery was defined as the time from onset of remission to the earliest time when the percentage of CD19+ total B cell among viable WBC is ≥ 1% or among lymphocyte is at least 3%.</description>
          <population>FAS patients who achieved CR or CRi. FAS: All subjects who received an infusion of CTL019</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5" lower_limit="7.6" upper_limit="NA">N/A = not estimable because there were not enough participants who had events to estimate the upper limit of the median</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment</title>
        <description>The levels (%) of CD19+ total B cells amongst viable white blood cells (WBC) in peripheral blood</description>
        <time_frame>Enrollment/Pre-Chemotherapy; Pre-infusion; Baseline; Day 7; Day 14; Day 21; Day 28; Month 3; Month 6; Month 9; Month 12; Month 24; Month 36</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>CR/CRi</title>
            <description>Participants had Complete remission (CR)/Complete remission with incomplete blood count recovery (CRi)</description>
          </group>
          <group group_id="O2">
            <title>No Response</title>
            <description>No response was defined as failure to attain the criteria needed for any response categories or relapse</description>
          </group>
          <group group_id="O3">
            <title>Unknown</title>
            <description>unknown was assigned in case the baseline assessment or the response assessment was not done, incomplete, indeterminate or not performed within the respective time frame.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment</title>
          <description>The levels (%) of CD19+ total B cells amongst viable white blood cells (WBC) in peripheral blood</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>Percentage of CD19+ B cell levels</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Enrollment/Pre-Chemotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" spread="28.733"/>
                    <measurement group_id="O2" value="52.29" spread="36.758"/>
                    <measurement group_id="O3" value="32.66" spread="28.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-infusion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="NA">N/A = Too few participants to calculate geometric SD</measurement>
                    <measurement group_id="O3" value="46.80" spread="NA">N/A = Too few participants to calculate geometric SD</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.11" spread="28.584"/>
                    <measurement group_id="O2" value="52.29" spread="36.758"/>
                    <measurement group_id="O3" value="29.50" spread="24.466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="3.735"/>
                    <measurement group_id="O2" value="34.40" spread="46.922"/>
                    <measurement group_id="O3" value="23.18" spread="38.772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="5.096"/>
                    <measurement group_id="O2" value="33.76" spread="45.359"/>
                    <measurement group_id="O3" value="3.43" spread="7.520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.017"/>
                    <measurement group_id="O2" value="19.67" spread="32.553"/>
                    <measurement group_id="O3" value="16.13" spread="35.929"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.069"/>
                    <measurement group_id="O2" value="34.97" spread="36.648"/>
                    <measurement group_id="O3" value="0.02" spread="0.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="1.971"/>
                    <measurement group_id="O2" value="0.57" spread="NA">N/A = Too few participants to calculate geometric SD</measurement>
                    <measurement group_id="O3" value="11.26" spread="15.917"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" spread="7.958"/>
                    <measurement group_id="O2" value="9.70" spread="NA">N/A = Too few participants to calculate geometric SD</measurement>
                    <measurement group_id="O3" value="0.01" spread="NA">N/A = Too few participants to calculate geometric SD</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="2.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="2.420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.74" spread="3.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="2.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)</title>
        <description>C-Reactive Protein at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
        <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>NO CRS</title>
            <description>No cytokine release syndrome</description>
          </group>
          <group group_id="O2">
            <title>Grade 1/2</title>
            <description>Grade 1 and 2 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O3">
            <title>Grade 3</title>
            <description>Grade 3 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O4">
            <title>Grade 4</title>
            <description>Grade 4 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O5">
            <title>All Participants</title>
            <description>All participants with &amp; without CRS</description>
          </group>
        </group_list>
        <measure>
          <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)</title>
          <description>C-Reactive Protein at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-infusion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.21" lower_limit="2.9" upper_limit="34.0"/>
                    <measurement group_id="O2" value="8.27" lower_limit="2.0" upper_limit="1530.0"/>
                    <measurement group_id="O3" value="7.45" lower_limit="0.6" upper_limit="50.0"/>
                    <measurement group_id="O4" value="9.00" lower_limit="2.0" upper_limit="153.0"/>
                    <measurement group_id="O5" value="9.00" lower_limit="0.6" upper_limit="1530.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (BL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.21" lower_limit="2.9" upper_limit="34.0"/>
                    <measurement group_id="O2" value="9.04" lower_limit="2.0" upper_limit="1530.0"/>
                    <measurement group_id="O3" value="7.45" lower_limit="0.6" upper_limit="50.0"/>
                    <measurement group_id="O4" value="9.00" lower_limit="2.0" upper_limit="153.0"/>
                    <measurement group_id="O5" value="9.00" lower_limit="0.6" upper_limit="1530.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-15.0" upper_limit="25.0"/>
                    <measurement group_id="O2" value="15.00" lower_limit="-460.0" upper_limit="215.0"/>
                    <measurement group_id="O3" value="79.55" lower_limit="-2.0" upper_limit="380.0"/>
                    <measurement group_id="O4" value="108.00" lower_limit="-125.0" upper_limit="255.0"/>
                    <measurement group_id="O5" value="9.10" lower_limit="-460.0" upper_limit="380.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-20.0" upper_limit="24.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-1031.0" upper_limit="215.0"/>
                    <measurement group_id="O3" value="10.50" lower_limit="-42.0" upper_limit="199.0"/>
                    <measurement group_id="O4" value="15.70" lower_limit="-148.0" upper_limit="100.0"/>
                    <measurement group_id="O5" value="0.00" lower_limit="-1031.0" upper_limit="215.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-14.0" upper_limit="29.5"/>
                    <measurement group_id="O2" value="-0.80" lower_limit="-1460.0" upper_limit="677.0"/>
                    <measurement group_id="O3" value="2.00" lower_limit="-42.0" upper_limit="37.0"/>
                    <measurement group_id="O4" value="-3.00" lower_limit="-57.0" upper_limit="73.0"/>
                    <measurement group_id="O5" value="0.00" lower_limit="-1460.0" upper_limit="677.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-15.0" upper_limit="47.0"/>
                    <measurement group_id="O2" value="-0.70" lower_limit="-1487.0" upper_limit="47.0"/>
                    <measurement group_id="O3" value="1.50" lower_limit="-45.0" upper_limit="55.0"/>
                    <measurement group_id="O4" value="-3.00" lower_limit="-151.0" upper_limit="27.0"/>
                    <measurement group_id="O5" value="0.00" lower_limit="-1487.0" upper_limit="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-12.1" upper_limit="101.0"/>
                    <measurement group_id="O2" value="-1.00" lower_limit="-1501.0" upper_limit="7.1"/>
                    <measurement group_id="O3" value="0.00" lower_limit="-3.0" upper_limit="120.5"/>
                    <measurement group_id="O4" value="-1.00" lower_limit="-149.0" upper_limit="13.0"/>
                    <measurement group_id="O5" value="-0.65" lower_limit="-1501.0" upper_limit="120.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin</title>
        <description>Ferritin at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
        <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>NO CRS</title>
            <description>No cytokine release syndrome</description>
          </group>
          <group group_id="O2">
            <title>Grade 1/2</title>
            <description>Grade 1 and 2 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O3">
            <title>Grade 3</title>
            <description>Grade 3 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O4">
            <title>Grade 4</title>
            <description>Grade 4 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O5">
            <title>All Participants</title>
            <description>All participants with &amp; without CRS</description>
          </group>
        </group_list>
        <measure>
          <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin</title>
          <description>Ferritin at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>ug/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-infusion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1865.20" lower_limit="459.0" upper_limit="5015.0"/>
                    <measurement group_id="O2" value="2202.22" lower_limit="230.0" upper_limit="18061.0"/>
                    <measurement group_id="O3" value="1906.95" lower_limit="357.0" upper_limit="4200.0"/>
                    <measurement group_id="O4" value="2078.40" lower_limit="487.0" upper_limit="13553.9"/>
                    <measurement group_id="O5" value="1983.90" lower_limit="230.0" upper_limit="18061.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (BL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1865.20" lower_limit="459.0" upper_limit="5015.0"/>
                    <measurement group_id="O2" value="2202.22" lower_limit="230.0" upper_limit="18061.0"/>
                    <measurement group_id="O3" value="1906.95" lower_limit="357.0" upper_limit="4200.0"/>
                    <measurement group_id="O4" value="2078.40" lower_limit="487.0" upper_limit="13553.9"/>
                    <measurement group_id="O5" value="1983.90" lower_limit="230.0" upper_limit="18061.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-146.50" lower_limit="-721.4" upper_limit="710.0"/>
                    <measurement group_id="O2" value="377.80" lower_limit="-1468.0" upper_limit="522220.0"/>
                    <measurement group_id="O3" value="22735.10" lower_limit="-330.0" upper_limit="182380.0"/>
                    <measurement group_id="O4" value="23788.71" lower_limit="-161.0" upper_limit="269529.0"/>
                    <measurement group_id="O5" value="358.90" lower_limit="-1468.0" upper_limit="269529.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-321.30" lower_limit="-2035.1" upper_limit="520.0"/>
                    <measurement group_id="O2" value="861.50" lower_limit="-3483.3" upper_limit="59435.9"/>
                    <measurement group_id="O3" value="10728.40" lower_limit="1262.0" upper_limit="104170.0"/>
                    <measurement group_id="O4" value="18580.01" lower_limit="707.0" upper_limit="110421.6"/>
                    <measurement group_id="O5" value="973.00" lower_limit="-3483.3" upper_limit="110421.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.00" lower_limit="-2302.0" upper_limit="524.0"/>
                    <measurement group_id="O2" value="331.00" lower_limit="-3571.6" upper_limit="43336.0"/>
                    <measurement group_id="O3" value="3299.85" lower_limit="-600.0" upper_limit="121100.0"/>
                    <measurement group_id="O4" value="3199.00" lower_limit="-17.0" upper_limit="12957.4"/>
                    <measurement group_id="O5" value="490.00" lower_limit="-3571.6" upper_limit="121100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.10" lower_limit="-2952.0" upper_limit="1510.0"/>
                    <measurement group_id="O2" value="283.00" lower_limit="-6443." upper_limit="9879.0"/>
                    <measurement group_id="O3" value="1104.00" lower_limit="-890.0" upper_limit="331000.0"/>
                    <measurement group_id="O4" value="1211.00" lower_limit="-606.0" upper_limit="12957.4"/>
                    <measurement group_id="O5" value="280.50" lower_limit="-6443.7" upper_limit="33100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-124.90" lower_limit="-2418.0" upper_limit="1985.5"/>
                    <measurement group_id="O2" value="-358.00" lower_limit="-5415.0" upper_limit="7050.0"/>
                    <measurement group_id="O3" value="-487.60" lower_limit="-1500.0" upper_limit="8140.0"/>
                    <measurement group_id="O4" value="-377.00" lower_limit="-1808.2" upper_limit="2641.6"/>
                    <measurement group_id="O5" value="-330.00" lower_limit="-5415.0" upper_limit="8140.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma</title>
        <description>INF-gamma at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
        <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>NO CRS</title>
            <description>No cytokine release syndrome</description>
          </group>
          <group group_id="O2">
            <title>Grade 1/2</title>
            <description>Grade 1 and 2 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O3">
            <title>Grade 3</title>
            <description>Grade 3 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O4">
            <title>Grade 4</title>
            <description>Grade 4 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O5">
            <title>All Participants</title>
            <description>All participants with &amp; without CRS</description>
          </group>
        </group_list>
        <measure>
          <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma</title>
          <description>INF-gamma at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-infusion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.63" lower_limit="1.0" upper_limit="283.0"/>
                    <measurement group_id="O2" value="23.39" lower_limit="1.0" upper_limit="242.8"/>
                    <measurement group_id="O3" value="15.73" lower_limit="6.4" upper_limit="31.5"/>
                    <measurement group_id="O4" value="5.79" lower_limit="2.5" upper_limit="34.1"/>
                    <measurement group_id="O5" value="20.22" lower_limit="1.0" upper_limit="283.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (BL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.63" lower_limit="1.0" upper_limit="283.0"/>
                    <measurement group_id="O2" value="22.51" lower_limit="1.0" upper_limit="242.8"/>
                    <measurement group_id="O3" value="15.73" lower_limit="6.4" upper_limit="31.5"/>
                    <measurement group_id="O4" value="4.77" lower_limit="1.0" upper_limit="34.1"/>
                    <measurement group_id="O5" value="15.75" lower_limit="1.0" upper_limit="283.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" lower_limit="-167.9" upper_limit="140.6"/>
                    <measurement group_id="O2" value="52.59" lower_limit="-201.2" upper_limit="39452.4"/>
                    <measurement group_id="O3" value="3023.82" lower_limit="-14.7" upper_limit="162376.0"/>
                    <measurement group_id="O4" value="1347.48" lower_limit="60.2" upper_limit="89599.0"/>
                    <measurement group_id="O5" value="72.09" lower_limit="-201.2" upper_limit="162376.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.10" lower_limit="-278.3" upper_limit="39.2"/>
                    <measurement group_id="O2" value="-4.44" lower_limit="-194.8" upper_limit="131.1"/>
                    <measurement group_id="O3" value="58.65" lower_limit="-14.3" upper_limit="1328.7"/>
                    <measurement group_id="O4" value="102.04" lower_limit="-2.2" upper_limit="8925.9"/>
                    <measurement group_id="O5" value="1.32" lower_limit="-278.3" upper_limit="8925.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.97" lower_limit="-264.0" upper_limit="58.5"/>
                    <measurement group_id="O2" value="1.06" lower_limit="-219.7" upper_limit="1384.6"/>
                    <measurement group_id="O3" value="0.53" lower_limit="-22.8" upper_limit="1048.7"/>
                    <measurement group_id="O4" value="5.23" lower_limit="-4.0" upper_limit="167.1"/>
                    <measurement group_id="O5" value="-0.89" lower_limit="-264.0" upper_limit="1384.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.93" lower_limit="-269.9" upper_limit="60.4"/>
                    <measurement group_id="O2" value="0.20" lower_limit="-223.6" upper_limit="738.8"/>
                    <measurement group_id="O3" value="-1.19" lower_limit="-26.1" upper_limit="187.7"/>
                    <measurement group_id="O4" value="0.36" lower_limit="-4.7" upper_limit="138.4"/>
                    <measurement group_id="O5" value="-0.62" lower_limit="-269.9" upper_limit="738.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.08" lower_limit="-278.6" upper_limit="167.5"/>
                    <measurement group_id="O2" value="-14.58" lower_limit="-173.9" upper_limit="7.6"/>
                    <measurement group_id="O3" value="21.25" lower_limit="-7.7" upper_limit="37.2"/>
                    <measurement group_id="O4" value="-0.67" lower_limit="-4.4" upper_limit="23.1"/>
                    <measurement group_id="O5" value="-5.71" lower_limit="-278.6" upper_limit="167.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)</title>
        <description>IL-6 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
        <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>NO CRS</title>
            <description>No cytokine release syndrome</description>
          </group>
          <group group_id="O2">
            <title>Grade 1/2</title>
            <description>Grade 1 and 2 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O3">
            <title>Grade 3</title>
            <description>Grade 3 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O4">
            <title>Grade 4</title>
            <description>Grade 4 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O5">
            <title>All Participants</title>
            <description>All participants with &amp; without CRS</description>
          </group>
        </group_list>
        <measure>
          <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)</title>
          <description>IL-6 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-infusion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" lower_limit="0.4" upper_limit="12.0"/>
                    <measurement group_id="O2" value="2.89" lower_limit="0.2" upper_limit="19.6"/>
                    <measurement group_id="O3" value="1.00" lower_limit="0.8" upper_limit="9.4"/>
                    <measurement group_id="O4" value="2.27" lower_limit="0.4" upper_limit="6.2"/>
                    <measurement group_id="O5" value="2.27" lower_limit="0.2" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (BL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" lower_limit="0.4" upper_limit="12.0"/>
                    <measurement group_id="O2" value="2.83" lower_limit="0.2" upper_limit="19.6"/>
                    <measurement group_id="O3" value="1.00" lower_limit="0.8" upper_limit="9.4"/>
                    <measurement group_id="O4" value="1.84" lower_limit="0.2" upper_limit="6.2"/>
                    <measurement group_id="O5" value="1.99" lower_limit="0.2" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" lower_limit="-9.6" upper_limit="4.3"/>
                    <measurement group_id="O2" value="2.64" lower_limit="-13.1" upper_limit="61.3"/>
                    <measurement group_id="O3" value="52.75" lower_limit="-0.6" upper_limit="7201.6"/>
                    <measurement group_id="O4" value="141.68" lower_limit="1.3" upper_limit="12615.8"/>
                    <measurement group_id="O5" value="2.64" lower_limit="-13.1" upper_limit="12615.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" lower_limit="-2.3" upper_limit="4.1"/>
                    <measurement group_id="O2" value="-0.67" lower_limit="-13.4" upper_limit="21.5"/>
                    <measurement group_id="O3" value="8.88" lower_limit="-0.6" upper_limit="30.4"/>
                    <measurement group_id="O4" value="165.16" lower_limit="-0.2" upper_limit="5734.8"/>
                    <measurement group_id="O5" value="-0.11" lower_limit="-13.4" upper_limit="5734.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.97" lower_limit="-5.3" upper_limit="5.3"/>
                    <measurement group_id="O2" value="-0.46" lower_limit="-15.4" upper_limit="103.4"/>
                    <measurement group_id="O3" value="1.65" lower_limit="-0.6" upper_limit="265.2"/>
                    <measurement group_id="O4" value="50.75" lower_limit="-0.2" upper_limit="5734.8"/>
                    <measurement group_id="O5" value="-0.09" lower_limit="-15.4" upper_limit="5734.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.98" lower_limit="-7.8" upper_limit="1.9"/>
                    <measurement group_id="O2" value="-0.28" lower_limit="-17.5" upper_limit="33.0"/>
                    <measurement group_id="O3" value="0.91" lower_limit="-0.6" upper_limit="138.6"/>
                    <measurement group_id="O4" value="38.13" lower_limit="-0.0" upper_limit="2148.4"/>
                    <measurement group_id="O5" value="-0.03" lower_limit="-17.5" upper_limit="2148.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" lower_limit="-10.8" upper_limit="22.7"/>
                    <measurement group_id="O2" value="-0.59" lower_limit="-8.9" upper_limit="1.2"/>
                    <measurement group_id="O3" value="0.56" lower_limit="-0.6" upper_limit="30.3"/>
                    <measurement group_id="O4" value="0.40" lower_limit="-0.9" upper_limit="3.2"/>
                    <measurement group_id="O5" value="-0.19" lower_limit="-10.8" upper_limit="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)</title>
        <description>IL-2 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
        <time_frame>Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3</time_frame>
        <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
        <group_list>
          <group group_id="O1">
            <title>NO CRS</title>
            <description>No cytokine release syndrome</description>
          </group>
          <group group_id="O2">
            <title>Grade 1/2</title>
            <description>Grade 1 and 2 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O3">
            <title>Grade 3</title>
            <description>Grade 3 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O4">
            <title>Grade 4</title>
            <description>Grade 4 of cytokine release syndrome post tisagenlecleucel infusion</description>
          </group>
          <group group_id="O5">
            <title>All Participants</title>
            <description>All participants with &amp; without CRS</description>
          </group>
        </group_list>
        <measure>
          <title>Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)</title>
          <description>IL-2 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3</description>
          <population>Safety set: All subjects who received an infusion of tisagenlecleucel</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-infusion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O2" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O3" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O4" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O5" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (BL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O2" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O3" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O4" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                    <measurement group_id="O5" value="2.3" lower_limit="2.3" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" lower_limit="0.0" upper_limit="6.7"/>
                    <measurement group_id="O2" value="3.15" lower_limit="0.0" upper_limit="7.0"/>
                    <measurement group_id="O3" value="13.14" lower_limit="5.0" upper_limit="63.7"/>
                    <measurement group_id="O4" value="7.48" lower_limit="2.9" upper_limit="12.1"/>
                    <measurement group_id="O5" value="5.16" lower_limit="0.0" upper_limit="63.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O4" value="4.56" lower_limit="4.56" upper_limit="4.6"/>
                    <measurement group_id="O5" value="0.00" lower_limit="0.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">N/A = below limit of detection</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Event (AE) timeframe: Adverse events were collected during the post-infusion period (starting at the day of first infusion until the end of the study), up to maximum duration of 60 months for each patient.</time_frame>
      <desc>AE description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).</desc>
      <group_list>
        <group group_id="E1">
          <title>Tisagenlecleucel (CTL019) - All Participants</title>
          <description>Pediatric participants with r/r B-cell who were infused with tisagenlecleucel</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Physical deconditioning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Graft versus host disease in gastrointestinal tract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cellulitis of male external genital organ</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rotavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Septic embolus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Transfusion related complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Glioblastoma multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Idiopathic intracranial hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood fibrinogen decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin M decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Safety data reported is based on all the 64 infused patients with data cutoff of 24May2019.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>novartis.email@novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02228096
org study id: CCTL019B2205J
secondary id: 2015-003736-13
nct id: NCT02228096
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This was a single arm, open-label, multi-center, phase II study to determine the efficacy and
      safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell
      acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or
      relapsed after allogeneic stem cell transplant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)
time frame: within 6 months after CTL019 infusion
description: ORR is defined as the percentage of participants with a best overall disease response of complete remission (CR) or Complete remission with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until the start of new anticancer therapy. Best response was assigned in the following order: CR, CRi, CR or CRi with residual mediastinal disease, No response and Unknown.
measure: Overall Remission Rate (ORR) Per Local Investigator Assessment (for Lymphoblastic Lymphoma Patients Only)
time frame: 6 months after CTL019
description: Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and cerebrospinal fluid (CSF). This primary endpoint was based on the local investigator assessment. No participants with lymphoblastic lymphoma were infused in this study.
measure: Percentage of Participants With Clinical Response Without Stem Cell Transplantation (SCT) at Month 6 - Per IRC Assessment
time frame: Month 6
description: Evaluate the percentage of participants who achieved CR or CRi at Month 6 without SCT between tisagenlecleucel infusion and Month 6 response assessment.
measure: Percentage of Subjects Who Achieved CR or CRi and Then Proceeded to SCT While in Remission Prior to Month 6 Response - Per IRC Assessment
time frame: prior to Month 6
description: Evaluate the percentage of subjects who achieved CR or CRi and then proceeded to SCT while in remission prior to Month 6 response assessment.
measure: Duration of Remission (DOR) Per Local and IRC Assessment
time frame: From CR or CRi to relapse or death up to 60 months
description: DOR is the time from achievement of CR or CRi, whichever occurs first, to relapse or death due to ALL
measure: Percentage of Participants With CR or CRi With Minimum Residual Disease (MRD) Negative Bone Marrow 6 Months After CTL019 Infusion
time frame: within 6 months
description: Percentage of participants with best overall response (BOR) of CR or CRi with MRD negative bone marrow status 6 months after CTL019 infusion among all participants who achieved CR or CRi per Local Investigator & IRC assessment
measure: Relapse-free Survival (RFS) for Responders Per Local and IRC Assessment
time frame: 60 Months
description: RFS is the time from achievement of CR or CRi whichever occurs first to relapse or death due to any cause during CR or CRi.
measure: Event-free Survival (EFS) Per Local and IRC Assessment
time frame: 60 Months
description: EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure. Treatment failure is defined as "no response" in the study and discontinuation from the study due to any of the following reasons: death, AE, lack of efficacy, new anticancer therapy.
measure: Overall Survival (OS)
time frame: 60 Months
description: OS is the time from date of CTL019 infusion to the date of death due to any reason
measure: Secondary Outcome: Percentage of Participants Attaining CR or CRi With MRD Negative Bone Marrow Status at Day 28 +/- 4 Days After CTL019 Infusion
time frame: Day 28
description: Percentage of participants attaining CR or CRi with MRD negative bone marrow status at Day 28 +/- 4 days after CTL019 infusion per Local Investigator and IRC assessment. BM MRD were only collected and measured only within responders.
measure: CTL019 Transgene Levels by qPCR CTL019 Cells by in qPCR Blood and Bone Marrow
time frame: Enrollment; D1; D4; D7; D11; D14; D21; D28; M3; M6; M9, M12; M18; M24, M30, M36, M42, M48 for transgene levels in blood; Screening, D28, M3, M6 for transgene levels in bone marrow
description: Characterize the in vivo cellular pharmacokinetic (PK) profile (levels,persistence, trafficking) of CTL019 cells in target tissues
measure: Humoral Immunogenicity Interpretation by Day 28 Disease Response Per IRC (Anti-CTL019 Antibodies)
time frame: Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36
description: Humoral immunogenicity was measured by anti-CTL019 antibodies in human serum using a flow cytometry method. (Prevalence and incidence of immunogenicity to CTL019)
measure: ORR by Low Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion
time frame: Within 6 months
description: ORR within 6 months after infusion of CTL019 per Local & IRC assessment by baseline bone marrow tumor burden presence.
measure: ORR by High Baseline Bone Marrow Burden Within 6 Months Post CTL019 Infusion
time frame: Within 6 months
description: ORR within 6 months after infusion of CTL019 per Local Investigator & IRC assessment by high baseline bone marrow tumor burden presence.
measure: ORR by Baseline Extramedullary Disease Presence of Yes Within 6 Months Post CTL019 Infusion
time frame: Within 6 months
description: ORR within 6 months after infusion of CTL019 per Local Investigator & IRC assessment by baseline extramedullary disease presence of Yes.
measure: ORR by Baseline Extramedullary Disease Presence of No Within 6 Months Post CTL019 Infusion
time frame: Within 6 months
description: ORR within 6 months after infusion of CTL019 per Local Investigator & IRC assessment by baseline extramedullary disease presence of No.
measure: Bone Marrow (BM) Minimum Residual Disease (MRD) Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by High Baseline Bone Marrow Tumor Burden
time frame: Within 6 months
description: BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion of CTL019 by baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.
measure: Bone Marrow MRD Status Was by Flow Cytometry Within 6 Months Post CTL019 Infusion by Low Baseline Bone Marrow Tumor Burden
time frame: Within 6 months
description: BM MRD status was per Local Investigator and IRC assessment within 6 months after infusion of CTL019 by low baseline bone marrow tumor burden. BM MRD were collected and measured only within responders.
measure: Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: Yes
time frame: Within 6 months
description: BM MRD status was by Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of Yes. BM MRD were collected and measured only within responders.
measure: Bone Marrow MRD Status by Flow Cytometry Within 6 Months Post CTL019 Infusion by Baseline Extramedullary Disease Presence: No
time frame: Within 6 months
description: BM MRD status WAS per Local Investigator and IRC assessment within 6 months after infusion pf CTL019 by baseline extramedullary disease presence of No. BM MRD were collected and measured only within responders.
measure: Duration of Remission (DoR) Censoring Hematopoietic Stem Cell Transplantation (HSCT) by Low Baseline Bone Marrow Tumor Burden
time frame: Within 6 months
description: DoR per Local Investigator & IRC assessment by low baseline marrow tumor burden
measure: Duration of Remission (DoR) Censoring HSCT by High Baseline Bone Marrow Tumor Burden
time frame: Within 6 months
description: DoR per Local Investigator & IRC assessment by high baseline bone marrow tumor burden
measure: Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: Yes
time frame: Within 6 months
description: DoR per Local Investigator & IRC assessment by baseline extramedullary disease presence of Yes.
measure: Duration of Remission (DoR) Censoring HSCT by Baseline Extramedullary Disease Presence: No
time frame: Within 6 months
description: DoR per Local Investigator & IRC assessment by baseline extramedullary disease presence of No
measure: Participants Achieving Cellular Immunogenicity Net Response by Day 28 Response Per IRC
time frame: Baseline; Day 14; Day 28; Month 3; Month 6; Month 12; Month 24, Month 36
description: Activation of T cells in PBMC collected from subjects in response to mCAR19 -derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. CD4 and CD8 T cell net responses (in %) were calculated for 2 non-overlapping CTL019 peptide pools (i.e., Pool 1 and Pool 2). (Lymphocyte subsets of B and T cells and description of associated safety events)
measure: Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: AUC0-28d and AUC0-84d
time frame: 0 - 28 days post-infusion for AUC0-28d and 0 - 84 days post-infusion for AUC0-84d
description: Characterize the in vivo cellular pharmacokinetic (PK) profile. AUC0-28d and AUC0-84d is defined as the AUC from time zero to day 28 and 84 or other disease assessment days, in peripheral blood (% or copies/μg x days). Data was only reported for evaluable PK parameters. The Overall Number of Participants Analyzed represents all participants for which a baseline assessment was collected for this Outcome Measure, and therefore these participants did contribute data to this estimation parameter, whereas the Number Analyzed per Row represents the number of participants with data available at either 28 or 84 days.
measure: Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Cmax
time frame: Day 28
description: Characterize the in vivo cellular pharmacokinetic (PK) profile. Cmax is defined as the maximum (peak) observed in peripheral blood drug concentration after single dose administration (% or copies/μg).
measure: Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Tmax
time frame: Day 28
description: Characterize the in vivo cellular pharmacokinetic (PK) profile. Tmax is defined as the time to reach maximum (peak) peripheral blood drug concentration after single dose administration (days)
measure: Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: T1/2
time frame: Day 28
description: Characterize the in vivo cellular pharmacokinetic (PK) profile. T1/2 is defined as the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve (days) in peripheral blood
measure: Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Clast
time frame: Day 28
description: Characterize the in vivo cellular pharmacokinetic (PK) profile. Clast is defined as the last observed quantifiable concentration in peripheral blood (% or copies/ug)
measure: Peripheral Blood PK Parameters for Tisagenlecleucel Transgene Levels by qPCR, by Day 28 Disease Response by Local & IRC Assessment: Tlast
time frame: Day 28
description: Characterize the in vivo cellular pharmacokinetic (PK) profile. Tlast is defined as the time of last observed quantifiable concentration in peripheral blood (days)"
measure: CD19 Status of Bone Marrow/Blood Relapse in FAS Patients Who Achieved CR or CRi and Then Relapsed
time frame: At time of relapse up to 60 months
description: The CD19 status of bone marrow/blood relapse was categorized as follows: CD19 positive, CD19 dim, CD19 negative, CD19 positive/negative & CD19 unknown
measure: Site of Initial Relapse Among FAS Patients Who Achieved CR/CRi and Then Relapsed
time frame: At time of relapse up to 60 months
description: This is the site of involvement of initial relapse after achieving a best overall response of CR/CRi.
measure: Time to B-cell Recovery in Participants Who Achieved CR or CRi by IRC
time frame: during the whole study, up to 60 months
description: Time to B cell recovery was defined as the time from onset of remission to the earliest time when the percentage of CD19+ total B cell among viable WBC is ≥ 1% or among lymphocyte is at least 3%.
measure: Percentage of CD19+ B Cell Levels in Peripheral Blood by Day 28 Disease Response by IRC Assessment
time frame: Enrollment/Pre-Chemotherapy; Pre-infusion; Baseline; Day 7; Day 14; Day 21; Day 28; Month 3; Month 6; Month 9; Month 12; Month 24; Month 36
description: The levels (%) of CD19+ total B cells amongst viable white blood cells (WBC) in peripheral blood
measure: Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: C Reactive Protein (CRP)
time frame: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
description: C-Reactive Protein at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
measure: Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Ferritin
time frame: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
description: Ferritin at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
measure: Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: INF-gamma
time frame: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
description: INF-gamma at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
measure: Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-6 (IL-6)
time frame: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
description: IL-6 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
measure: Key Inflammatory Markers and Cytokine Parameters in Blood Within 1 Month by Maximum Cytokine Release Syndrome (CRS) Grade: Interleukin-2 (IL-2)
time frame: Pre-infusion, Baseline, Day 7, Day 14, Day 21, Day 28, Month 3
description: IL-2 at Pre-infusion, baseline, and change from baseline for Days 7, 14, 21, 28, Month 3
arm group label: tisagenlecleucel (CTL019)
arm group type: Experimental
description: Pediatric patients with relapsed/refractory B-cell ALL
intervention type: Biological
intervention name: CTL019 T-cells
description: A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients > 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients > 50 kg).
arm group label: tisagenlecleucel (CTL019)
other name: tisagenlecleucel
criteria: 
gender: All
minimum age: 3 Years
maximum age: 21 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Tisagenlecleucel
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
ipd url: http://www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Safety data reported is based on all the 64 infused patients with data cutoff of 24May2019.
point of contact: 