<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/NCT02981628</url>
  </required_header>
  <id_info>
    <org_study_id>AALL1621</org_study_id>
    <secondary_id>NCI-2016-01494</secondary_id>
    <secondary_id>AALL1621</secondary_id>
    <secondary_id>AALL1621</secondary_id>
    <secondary_id>U10CA180886</secondary_id>
    <nct_id>NCT02981628</nct_id>
  </id_info>
  <brief_title>Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia</brief_title>
  <official_title>A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Oncology Group</source>
  <oversight_info>
    <has_dmc>No</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 phase II trial studies how well inotuzumab ozogamicin works in treating younger patients&#xD;
      with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come&#xD;
      back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a&#xD;
      monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab&#xD;
      attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill&#xD;
      them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the morphologic response rate (complete response [CR] + complete response&#xD;
      with incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab&#xD;
      ozogamicin in children with relapsed or refractory CD22+ B acute lymphoblastic leukemia&#xD;
      (B-ALL). (Cohort 1)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the CR/CRi rate following 2 cycles of inotuzumab ozogamicin therapy. (Cohort&#xD;
      1) II. To determine the safety of single agent inotuzumab ozogamicin administered at the&#xD;
      adult recommended phase 2 dose (RP2D) to pediatric patients with relapsed or refractory CD22+&#xD;
      B-ALL. (Cohort 1) III. To determine the level of minimal residual disease (MRD) by flow&#xD;
      cytometry in responding patients. (Cohorts 1 and 2) IV. To determine the incidence, severity,&#xD;
      and outcomes of sinusoidal obstruction syndrome (SOS) of the liver in patients during&#xD;
      inotuzumab ozogamicin therapy and following subsequent treatment, including myeloablative&#xD;
      hematopoietic stem cell transplantation (HSCT). (Cohorts 1 and 2) V. To estimate the 3-year&#xD;
      event-free survival (EFS), 3-year overall survival (OS), and among responders, duration of&#xD;
      CR/CRi for pediatric patients with relapsed or refractory B-ALL treated with inotuzumab&#xD;
      ozogamicin. (Cohort 1) VI. To describe inotuzumab ozogamicin pharmacokinetics and&#xD;
      immunogenicity in pediatric patients in the presence of overt leukemia and in remission.&#xD;
      (Cohort 1) VII. To determine the safe and tolerable dose of inotuzumab ozogamicin in&#xD;
      combination with the augmented modified Berlin-Frankfurt-Munster (mBFM) consolidation&#xD;
      chemotherapy backbone. (Cohort 2)&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To describe the levels of leukemic blast CD22 surface expression and site density, and to&#xD;
      explore the correlation with cytogenetics and clinical outcomes after treatment with&#xD;
      inotuzumab ozogamicin. (Cohorts 1 and 2) II. To explore potential mechanisms of resistance to&#xD;
      inotuzumab ozogamicin therapy including CD22 splice variants and intracellular signaling&#xD;
      pathways. (Cohorts 1 and 2) III. To explore the impact of inotuzumab ozogamicin on humoral&#xD;
      immune function and peripheral B cell populations. (Cohorts 1 and 2) IV. To describe the&#xD;
      level of MRD by next-generation high-throughput sequencing (HTS) techniques which may detect&#xD;
      low level leukemic blast populations that have altered CD22 expression. (Cohorts 1 and 2) V.&#xD;
      To prospectively explore candidate SOS biomarkers including the endothelial marker of&#xD;
      inflammation Angiopoietin 2 (Ang2) and the hepatic specific complement marker L-ficolin.&#xD;
      (Cohorts 1 and 2) VI. To explore the use of prophylactic ursodeoxycholic acid (UDCA) to&#xD;
      prevent hepatic damage and SOS during inotuzumab ozogamicin therapy and subsequent HSCT.&#xD;
      (Cohorts 1 and 2) VII. To describe the interaction between inotuzumab ozogamicin and chimeric&#xD;
      antigen receptor (CAR) T cell therapy before or after treatment with inotuzumab ozogamicin.&#xD;
      (Cohorts 1 and 2) VIII. To estimate the CR/CRi rate following one cycle of inotuzumab&#xD;
      ozogamicin plus augmented mBFM consolidation chemotherapy (first 42 days) and following 2&#xD;
      cycles within the confines of a pilot study. (Cohort 2)&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 cohorts.&#xD;
&#xD;
      COHORT I: Patients receive inotuzumab ozogamicin intravenously (IV) over 60 minutes on days&#xD;
      1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence&#xD;
      of disease progression or unacceptable toxicity. (COMPLETE)&#xD;
&#xD;
      COHORT II: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15.&#xD;
      Patients also receive cyclophosphamide IV over 30-60 on day 1; cytarabine IV over 1-30&#xD;
      minutes or subcutaneously (SC) on days 1-4 and 8-11; leucovorin calcium orally (PO) or IV on&#xD;
      days 2, 9, 16, 23 and 37 of cycle 1 and days 9 and 37 of cycle 2; pegaspargase or&#xD;
      calaspargase pegol IV over 1-2 hours or pegaspargase intramuscularly (IM) on day 22; and&#xD;
      vincristine IV on days 22 and 29. Patients receive methotrexate intrathecally (IT) on days 1,&#xD;
      8 and 36 of cycle 1 and day 36 of cycle 2 for CNS 1 patients, days 1, 8, 15, 22 and 36 of&#xD;
      cycle 1, and day 36 of cycle 2 for CNS 2 patients. CNS 3 patients receive methotrexate&#xD;
      intrathecal triple therapy (ITT) IT on days 1, 8, 15, 22 and 36 of cycle 1 and days 8 and 36&#xD;
      of cycle 2. There will be 3 dose levels. If excessive toxicity is observed at dose level 1,&#xD;
      the dosing of inotuzumab ozogamicin will be decreased for dose level -1. If excessive&#xD;
      toxicity is observed at this dose, then for dose level -2, pegaspargase/calaspargase pegol&#xD;
      will be omitted. Treatment repeats every 42 days for up to 2 cycles in the absence of disease&#xD;
      progression or unacceptable toxicity. Patients undergo bone marrow aspiration or biopsy,&#xD;
      lumbar puncture, and blood sample collection throughout the trial. Patients also undergo&#xD;
      imaging on screening and on study.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 days, every 3 months for&#xD;
      1 year, and then yearly for 4 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 5, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. A one-sided lower 95% Agresti-Coull confidence limit will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphologic response (CR + CRi) following 2 cycles of inotuzumab ozogamicin therapy (Cohort1)</measure>
    <time_frame>Up to 56 days</time_frame>
    <description>The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of dose-limiting toxicities at recommended phase II dose (RP2D) (Cohort 1)</measure>
    <time_frame>During Cycle 1, up to 28 days</time_frame>
    <description>Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of minimal residual disease (MRD) assessed in bone marrow by flow cytometry (Cohort 1 and 2)</measure>
    <time_frame>Up to 2 cycles</time_frame>
    <description>MRD negativity rates (&lt; 0.01% detectable leukemia cells) will be estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events of sinusoidal obstruction syndrome (SOS) of liver (Cohort 1 and 2)</measure>
    <time_frame>Up to 1 year from last dose of Inotuzumab ozogamicin</time_frame>
    <description>Evaluated according to NCI CTCAE version 5.0. The incidence of SOS of the liver in patients during inotuzumab ozogamicin therapy and following subsequent treatment including myeloablative hematopoietic cell transplantation (HSCT) will be described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event free survival (EFS) (Cohort 1)</measure>
    <time_frame>From study entry to first event (induction failure, induction death, relapse, second malignancy, remission death), or date of last follow-up for event free subjects, assessed up to 3 years</time_frame>
    <description>The EFS rate will be estimated using Kaplan Meier approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) (Cohort 1)</measure>
    <time_frame>From the time from study entry to death or date of last follow-up, assessed up to 3 years</time_frame>
    <description>The OS rate will be estimated using Kaplan Meier approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CR, CRi (Cohort 1)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Among responding patients, three-year complete continuous response will also be estimated using duration of CR/CRi for the overall responding group and stratified by whether or not the patients proceed to HSCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) parameters, i.e., inotuzumab ozogamicin trough levels (Cohort 1)</measure>
    <time_frame>Cycles 1 and 2 (each cycle is 28 days)</time_frame>
    <description>Inotuzumab ozogamicin trough levels (ng/mL) will be determined in serum by validated, high sensitivity liquid chromatography-mass spectrometry (LCMS) assays. Descriptive summary statistics will be provided for the trough levels at scheduled visits for Cycles 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity (Cohort 1)</measure>
    <time_frame>Cycles 1 and 2</time_frame>
    <description>Enhanced chemiluminescence (ECL) and cell-based assays will be used to detect anti-drug antibodies and neutralizing antibodies to inotuzumab ozogamicin in serum. Inotuzumab ozogamicin trough levels will be compared between patients with and without antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of dose-limiting toxicities at the selected dose level of inotuzumab ozogamicin in combination with the augmented modified Berlin-Frankfurt-Munster (mBFM) consolidation chemotherapy (Cohort 2)</measure>
    <time_frame>Up to cycle 1 (each cycle is 42 days)</time_frame>
    <description>Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in CD22 surface expression (Cohorts 1 and 2)</measure>
    <time_frame>Baseline, post Cycle 1, and at time of relapse</time_frame>
    <description>Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 expression pre and post-inotuzumab ozogamicin. Specifically, samples will be evaluated for change in CD22 expression that occurs over time to study the role of CD22 expression as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 expression and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in CD22 site density (Cohorts 1 and 2)</measure>
    <time_frame>Baseline, post Cycle 1, and at time of relapse</time_frame>
    <description>Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 site density pre and post-inotuzumab ozogamicin. Samples will be evaluated for any change in CD22 site density that occurs over time and to evaluate for the emergence of a CD22 &quot;dim&quot; or &quot;negative&quot; population to study the role of CD22 site density as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 site density and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).</description>
  </other_outcome>
  <other_outcome>
    <measure>Leukemic blast CD22 splice variants (Cohorts 1 and 2)</measure>
    <time_frame>Baseline, post-Cycle 1, and at time of relapse</time_frame>
    <description>Will be analyzed by ribonucleic acid-sequencing (RNA-Seq). The MAJIQ and VOILA software will be used to identify splicing variations in CD22 from RNA Seq and to quantitate the percent spliced in (PSI) of the alternative exons. CD22 protein levels will be determined by immunoblotting of whole cell protein lysates using several anti-CD22 antibodies recognizing either extracellular or intracellular domains. Both protein sizes and preservation of individual epitopes will be assessed and correlated with alterations in exon inclusion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intracellular signaling pathways in leukemic blasts treated with inotuzumab ozogamicin (Cohorts 1 and 2)</measure>
    <time_frame>Baseline up to 5 years</time_frame>
    <description>Peripheral blood samples will be evaluated by comprehensive protein profiling using CyTOF panels for the two major areas of analyses, surface immunophenotyping to assess the developmental stage of both normal and abnormal B cells and measure their responses to inotuzumab ozogamicin , as well as intracellular epitopes to assess the cellular consequences of treatment with inotuzumab ozogamicin. Exploratory analysis will be performed using Cytobank software tools (viSNE, SPADE and CITRUS) for subpopulations clustering, dimensionality reduction and hierarchical organization.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in peripheral blood absolute B cell numbers and maturation of developing B cell populations with inotuzumab ozogamicin therapy (Cohorts 1 and 2)</measure>
    <time_frame>Baseline up to 5 years</time_frame>
    <description>Descriptive statistics will be used to characterize patterns of B-cell development including selective loss of subsets. Changes in B cell number and subsets will be described, and exploratory analysis will be conducted to assess their correlation with clinical features including immunoglobulin levels, occurrence of infections, and need for intravenous immunoglobulin (IVIG) replacement during inotuzumab ozogamicin therapy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of MRD by next-generation high-throughput sequencing (HTS) techniques (Cohorts 1 and 2)</measure>
    <time_frame>Up to 2 cycles</time_frame>
    <description>Compared to MRD measured by flow cytometry. MRD levels at each bone marrow evaluation time point will be measured by standard flow cytometry (MRD-negative defined as &lt; 0.01% or 1 leukemic cell in 10-4 nucleated cells). At the end of cycles 1 and 2, MRD will also be assessed by HTS. The correlation between the measurements with each technique will be described and the sensitivity of flow-based MRD methodology in the setting of CD22-targeted therapy will be explored.</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum levels of candidate SOS biomarkers Ang2 and L ficolin (Cohorts 1 and 2)</measure>
    <time_frame>Up to 12 months from last dose of inotuzumab ozogamicin</time_frame>
    <description>Correlated with clinical development of SOS. Descriptive statistics will be used to characterize clinical features of patients experiencing SOS. L-ficolin and Ang2 absolute levels and change in level over time with inotuzumab ozogamicin exposure will be evaluated and correlated with development of SOS. Biomarker levels will be compared using simple comparative statistics between subgroups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of SOS in patients who receive prophylaxis with ursodeoxycholic acid (UDCA) during inotuzumab ozogamicin therapy (Cohorts 1 and 2)</measure>
    <time_frame>Up to 12 months from last dose of inotuzumab ozogamicin</time_frame>
    <description>Descriptive statistics will be used to characterize clinical features of patients experiencing SOS, potential clinical risk factors, and the impact of ursodeoxycholic acid prophylaxis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Interaction between CAR- T therapy and inotuzumab ozogamicin (Cohorts 1 and 2)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be evaluated by incidence of hematologic DLT in patients with CAR-T therapy prior to inotuzumab ozogamicin, incidence of post-inotuzumab ozogamicin CAR-T therapy, time to CAR-T therapy after inotuzumab ozogamicin, and B-cell recovery prior to CAR-T therapy after inotuzumab ozogamicin. Will be summarized using descriptive statistics.</description>
  </other_outcome>
  <other_outcome>
    <measure>Morphologic response (CR/CRi) (Cohort 2)</measure>
    <time_frame>Up to 2 cycles (each cycle is 42 days)</time_frame>
    <description>Will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. Analysis will be mostly descriptive.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Recurrent B Acute Lymphoblastic Leukemia</condition>
  <condition>Recurrent B Lymphoblastic Lymphoma</condition>
  <condition>Refractory B Acute Lymphoblastic Leukemia</condition>
  <condition>Refractory B Lymphoblastic Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cohort I (inotuzumab ozogamicin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. (COMPLETE)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Detailed Description</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo blood sample collection</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone Marrow Aspiration and Biopsy</intervention_name>
    <description>Undergo a bone marrow aspiration and biopsy</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calaspargase Pegol</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)</other_name>
    <other_name>Asparlas</other_name>
    <other_name>Calaspargase Pegol-mknl</other_name>
    <other_name>EZN-2285</other_name>
    <other_name>SC-PEG E. Coli L-Asparaginase</other_name>
    <other_name>Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>(-)-Cyclophosphamide</other_name>
    <other_name>2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate</other_name>
    <other_name>Carloxan</other_name>
    <other_name>Ciclofosfamida</other_name>
    <other_name>Ciclofosfamide</other_name>
    <other_name>Cicloxal</other_name>
    <other_name>Clafen</other_name>
    <other_name>Claphene</other_name>
    <other_name>CP monohydrate</other_name>
    <other_name>CTX</other_name>
    <other_name>CYCLO-cell</other_name>
    <other_name>Cycloblastin</other_name>
    <other_name>Cycloblastine</other_name>
    <other_name>Cyclophospham</other_name>
    <other_name>Cyclophosphamid monohydrate</other_name>
    <other_name>Cyclophosphamide Monohydrate</other_name>
    <other_name>Cyclophosphamidum</other_name>
    <other_name>Cyclophosphan</other_name>
    <other_name>Cyclophosphane</other_name>
    <other_name>Cyclophosphanum</other_name>
    <other_name>Cyclostin</other_name>
    <other_name>Cyclostine</other_name>
    <other_name>Cytophosphan</other_name>
    <other_name>Cytophosphane</other_name>
    <other_name>Cytoxan</other_name>
    <other_name>Fosfaseron</other_name>
    <other_name>Genoxal</other_name>
    <other_name>Genuxal</other_name>
    <other_name>Ledoxina</other_name>
    <other_name>Mitoxan</other_name>
    <other_name>Neosar</other_name>
    <other_name>Revimmune</other_name>
    <other_name>Syklofosfamid</other_name>
    <other_name>WR- 138719</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Given IV or SC</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>.beta.-Cytosine arabinoside</other_name>
    <other_name>1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-Beta-D-arabinofuranosylcytosine</other_name>
    <other_name>1.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-</other_name>
    <other_name>Alexan</other_name>
    <other_name>Ara-C</other_name>
    <other_name>ARA-cell</other_name>
    <other_name>Arabine</other_name>
    <other_name>Arabinofuranosylcytosine</other_name>
    <other_name>Arabinosylcytosine</other_name>
    <other_name>Aracytidine</other_name>
    <other_name>Aracytin</other_name>
    <other_name>Aracytine</other_name>
    <other_name>Beta-Cytosine Arabinoside</other_name>
    <other_name>CHX-3311</other_name>
    <other_name>Cytarabinum</other_name>
    <other_name>Cytarbel</other_name>
    <other_name>Cytosar</other_name>
    <other_name>Cytosine Arabinoside</other_name>
    <other_name>Cytosine-.beta.-arabinoside</other_name>
    <other_name>Cytosine-beta-arabinoside</other_name>
    <other_name>Erpalfa</other_name>
    <other_name>Starasid</other_name>
    <other_name>Tarabine PFS</other_name>
    <other_name>U 19920</other_name>
    <other_name>U-19920</other_name>
    <other_name>Udicil</other_name>
    <other_name>WR-28453</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic Imaging</intervention_name>
    <description>Undergo imaging</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Medical Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Inotuzumab Ozogamicin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Cohort I (inotuzumab ozogamicin)</arm_group_label>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Besponsa</other_name>
    <other_name>CMC-544</other_name>
    <other_name>Way 207294</other_name>
    <other_name>WAY-207294</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leucovorin Calcium</intervention_name>
    <description>Given PO or IV</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Adinepar</other_name>
    <other_name>Calcifolin</other_name>
    <other_name>Calcium (6S)-Folinate</other_name>
    <other_name>Calcium Folinate</other_name>
    <other_name>Calcium Leucovorin</other_name>
    <other_name>Calfolex</other_name>
    <other_name>Calinat</other_name>
    <other_name>Cehafolin</other_name>
    <other_name>Citofolin</other_name>
    <other_name>Citrec</other_name>
    <other_name>Citrovorum Factor</other_name>
    <other_name>Cromatonbic Folinico</other_name>
    <other_name>Dalisol</other_name>
    <other_name>Disintox</other_name>
    <other_name>Divical</other_name>
    <other_name>Ecofol</other_name>
    <other_name>Emovis</other_name>
    <other_name>Factor, Citrovorum</other_name>
    <other_name>Flynoken A</other_name>
    <other_name>Folaren</other_name>
    <other_name>Folaxin</other_name>
    <other_name>FOLI-cell</other_name>
    <other_name>Foliben</other_name>
    <other_name>Folidan</other_name>
    <other_name>Folidar</other_name>
    <other_name>Folinac</other_name>
    <other_name>Folinate Calcium</other_name>
    <other_name>folinic acid</other_name>
    <other_name>Folinic Acid Calcium Salt Pentahydrate</other_name>
    <other_name>Folinoral</other_name>
    <other_name>Folinvit</other_name>
    <other_name>Foliplus</other_name>
    <other_name>Folix</other_name>
    <other_name>Imo</other_name>
    <other_name>Lederfolat</other_name>
    <other_name>Lederfolin</other_name>
    <other_name>Leucosar</other_name>
    <other_name>leucovorin</other_name>
    <other_name>Rescufolin</other_name>
    <other_name>Rescuvolin</other_name>
    <other_name>Tonofolin</other_name>
    <other_name>Wellcovorin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar Puncture</intervention_name>
    <description>Undergo lumbar puncture</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>LP</other_name>
    <other_name>Spinal Tap</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Given IT</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Abitrexate</other_name>
    <other_name>Alpha-Methopterin</other_name>
    <other_name>Amethopterin</other_name>
    <other_name>Brimexate</other_name>
    <other_name>CL 14377</other_name>
    <other_name>CL-14377</other_name>
    <other_name>Emtexate</other_name>
    <other_name>Emthexat</other_name>
    <other_name>Emthexate</other_name>
    <other_name>Farmitrexat</other_name>
    <other_name>Fauldexato</other_name>
    <other_name>Folex</other_name>
    <other_name>Folex PFS</other_name>
    <other_name>Lantarel</other_name>
    <other_name>Ledertrexate</other_name>
    <other_name>Lumexon</other_name>
    <other_name>Maxtrex</other_name>
    <other_name>Medsatrexate</other_name>
    <other_name>Metex</other_name>
    <other_name>Methoblastin</other_name>
    <other_name>Methotrexate LPF</other_name>
    <other_name>Methotrexate Methylaminopterin</other_name>
    <other_name>Methotrexatum</other_name>
    <other_name>Metotrexato</other_name>
    <other_name>Metrotex</other_name>
    <other_name>Mexate</other_name>
    <other_name>Mexate-AQ</other_name>
    <other_name>MTX</other_name>
    <other_name>Novatrex</other_name>
    <other_name>Rheumatrex</other_name>
    <other_name>Texate</other_name>
    <other_name>Tremetex</other_name>
    <other_name>Trexeron</other_name>
    <other_name>Trixilem</other_name>
    <other_name>WR-19039</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegaspargase</intervention_name>
    <description>Given IV or IM</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>L-Asparaginase with Polyethylene Glycol</other_name>
    <other_name>Oncaspar</other_name>
    <other_name>Oncaspar-IV</other_name>
    <other_name>PEG-Asparaginase</other_name>
    <other_name>PEG-L-Asparaginase</other_name>
    <other_name>PEG-L-Asparaginase (Enzon - Kyowa Hakko)</other_name>
    <other_name>PEGLA</other_name>
    <other_name>Polyethylene Glycol L-Asparaginase</other_name>
    <other_name>Polyethylene Glycol-L-Asparaginase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)</arm_group_label>
    <other_name>Leurocristine</other_name>
    <other_name>VCR</other_name>
    <other_name>Vincrystine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be &gt;= 1 year and &lt; 22 years of age at the time of enrollment&#xD;
&#xD;
          -  Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL),&#xD;
             with &gt;= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease&#xD;
&#xD;
               -  NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL)&#xD;
                  are eligible if they have an M2 or M3 marrow at the time of enrollment on this&#xD;
                  study&#xD;
&#xD;
          -  Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing&#xD;
             showing &gt;= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH)&#xD;
             testing or other molecular method&#xD;
&#xD;
          -  Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by&#xD;
             local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of&#xD;
             CD22 using a bright fluorophore such as phycoerythrin [PE] is strongly recommended)&#xD;
&#xD;
               -  In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate&#xD;
                  is unable to be performed due to patient clinical status, flow cytometry of&#xD;
                  peripheral blood specimen may be substituted if the patient has at least 1,000/uL&#xD;
                  circulating blasts; alternatively, CD22 expression may be documented by&#xD;
                  immunohistochemistry of a bone marrow biopsy specimen&#xD;
&#xD;
          -  Patients with one of the following:&#xD;
&#xD;
               -  Second or greater relapse;&#xD;
&#xD;
               -  Primary refractory disease with at least 2 prior induction attempts;&#xD;
&#xD;
               -  First relapse refractory to at least one prior re-induction attempt&#xD;
&#xD;
               -  Any relapse after HSCT (Cohort 1 ONLY)&#xD;
&#xD;
        Patients with Down syndrome are eligible ONLY for Cohort 1 with:&#xD;
&#xD;
          -  Any of above disease status, OR&#xD;
&#xD;
          -  First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or&#xD;
             prior HSCT are NOT eligible for Cohort 2 combination therapy&#xD;
&#xD;
               -  Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy&#xD;
                  attempts including two different tyrosine kinase inhibitors (TKIs)&#xD;
&#xD;
               -  Patients must have fully recovered from the acute toxic effects of all prior&#xD;
                  anti-cancer therapy, defined as resolution of all such toxicities to =&lt; grade 2&#xD;
                  or lower per the inclusion/exclusion criteria prior to entering this study. Apply&#xD;
                  to Cohort 2:&#xD;
&#xD;
          -  Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For&#xD;
             agents not listed, the duration of this interval must be discussed with the study&#xD;
             chair and the study-assigned Research Coordinator prior to enrollment.&#xD;
&#xD;
               -  A waiting period prior to enrollment is not required for patients receiving&#xD;
                  standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine,&#xD;
                  6MP, and/or methotrexate).&#xD;
&#xD;
               -  A waiting period is not required for patients receiving a single dose of&#xD;
                  intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior&#xD;
                  to enrollment&#xD;
&#xD;
               -  &gt;= 14 days must have elapsed after the completion of other cytotoxic therapy,&#xD;
                  with the exception of hydroxyurea, for patients not receiving standard&#xD;
                  maintenance therapy. For patients who previously received calaspargase pegol, &gt;=&#xD;
                  21 days must have elapsed after the last dose. Additionally, patients must have&#xD;
                  fully recovered from all acute toxic effects of prior therapy.&#xD;
&#xD;
                    -  Note: Cytoreduction with hydroxyurea must be discontinued &gt;= 24 hours prior&#xD;
                       to the start of protocol therapy.&#xD;
&#xD;
          -  Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced&#xD;
             platelet or absolute neutrophil count [ANC] counts): &gt;= 7 days after the last dose of&#xD;
             agent. For agents not listed, the duration of this interval must be discussed with the&#xD;
             study chair and the study-assigned research coordinator prior to enrollment.&#xD;
&#xD;
          -  Anti-cancer agents that are antibodies: &gt;= 21 days must have elapsed from infusion of&#xD;
             last dose of antibody, and toxicity related to prior antibody therapy must be&#xD;
             recovered to grade =&lt; 1. There is an exception for blinatumomab infusions, for which&#xD;
             patients must have been off for at least 3 days and all drug related toxicity must&#xD;
             have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria.&#xD;
&#xD;
          -  Corticosteroids: If used to modify immune adverse events related to prior therapy, &gt;=&#xD;
             14 days must have elapsed since last dose of corticosteroid. A waiting period prior to&#xD;
             enrollment is not required for patients receiving corticosteroid for leukemia&#xD;
             therapy/cytoreduction.&#xD;
&#xD;
          -  Radiotherapy: &gt;= 2 weeks must have elapsed since local palliative radiation therapy&#xD;
             (XRT) (small port); &gt;= 3 months must have elapsed if prior cranial or craniospinal XRT&#xD;
             was received, if &gt;= 50% of the pelvis was irradiated, or if total body irradiation&#xD;
             (TBI) was received; &gt;= 6 weeks must have elapsed if other substantial bone marrow&#xD;
             irradiation was given.&#xD;
&#xD;
          -  Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have&#xD;
             elapsed since stem cell transplant and at least 30 days from donor lymphocyte&#xD;
             infusion. Patient must have had no more than one previous HSCT and currently have no&#xD;
             evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is&#xD;
             allowed.&#xD;
&#xD;
          -  Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed&#xD;
             from the last CAR-T cell infusion&#xD;
&#xD;
               -  Patients must have a performance status corresponding to Eastern Cooperative&#xD;
                  Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients &gt; 16 years&#xD;
                  of age and Lansky for patients =&lt; 16 years of age; patients who are unable to&#xD;
                  walk because of paralysis, but who are up in a wheelchair, will be considered&#xD;
                  ambulatory for the purpose of assessing the performance score&#xD;
&#xD;
               -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) &gt;= 70&#xD;
                  mL/min/1.73 m^2 or&#xD;
&#xD;
               -  A serum creatinine based on age/gender as follows:&#xD;
&#xD;
          -  1 to &lt; 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)&#xD;
&#xD;
          -  2 to &lt; 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)&#xD;
&#xD;
          -  6 to &lt; 10 years: maximum serum creatinine 1 mg/dL (both male and female)&#xD;
&#xD;
          -  10 to &lt; 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)&#xD;
&#xD;
          -  13 to &lt; 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)&#xD;
&#xD;
          -  &gt;= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)&#xD;
&#xD;
               -  Direct bilirubin =&lt; 1.5 x upper limit of normal (ULN) for age, and&#xD;
&#xD;
               -  Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =&lt; 5&#xD;
                  x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any prior history of SOS irrespective of severity&#xD;
&#xD;
          -  Patients with isolated central nervous system (CNS), testicular, or any other&#xD;
             extramedullary site of relapse&#xD;
&#xD;
          -  Patients who have been previously treated with inotuzumab ozogamicin&#xD;
&#xD;
          -  Patients who have previously received HSCT (Cohort 2 only)&#xD;
&#xD;
          -  Patients with Down syndrome (Cohort 2 only)&#xD;
&#xD;
          -  History of allergic reaction attributed to compounds of similar or biologic&#xD;
             composition to inotuzumab ozogamicin or other agents in the study&#xD;
&#xD;
               -  Note: Patients with history of allergy to pegaspargase/calaspargase pegol are&#xD;
                  eligible for enrollment on Cohort 2 (dose levels 1 and -1) if Erwinia formulation&#xD;
                  of asparaginase can be obtained&#xD;
&#xD;
               -  If Cohort 2 is enrolling at dose level -2, then patients who cannot receive&#xD;
                  asparaginase due to prior allergy, toxicity, or lack of access may enroll&#xD;
&#xD;
               -  NOTE: patients on AALL1621 are not eligible to co-enroll on AALL1931&#xD;
&#xD;
          -  Patients with active optic nerve and/or retinal involvement are not eligible; patients&#xD;
             who are presenting with visual disturbances should have an ophthalmologic exam and, if&#xD;
             indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal&#xD;
             involvement&#xD;
&#xD;
          -  Patients who are currently receiving another investigational drug&#xD;
&#xD;
          -  Patients who are currently receiving or plan to receive other anti-cancer agents&#xD;
             (except hydroxyurea, which may be continued until 24 hours prior to start of protocol&#xD;
             therapy, and intrathecal chemotherapy)&#xD;
&#xD;
          -  Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are&#xD;
             receiving cyclosporine, tacrolimus, or other agents to prevent either&#xD;
             graft-versus-host disease post bone marrow transplant or organ rejection&#xD;
             post-transplant are not eligible for this trial; at least 3 half-lives must have&#xD;
             elapsed after the last dose of GVHD or anti-rejection medications&#xD;
&#xD;
          -  Patients who are currently receiving or plan to receive corticosteroids except as&#xD;
             described below&#xD;
&#xD;
               -  Systemic corticosteroids may be administered for cytoreduction up to 24 hours&#xD;
                  prior to the start of protocol therapy, (Cohort 1 only) for all patients,&#xD;
                  corticosteroids may be administered as a premedication for inotuzumab ozogamicin&#xD;
                  and as treatment for allergic reactions or for physiologic replacement/stress&#xD;
                  dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids&#xD;
                  are not allowed for other indications&#xD;
&#xD;
          -  Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections;&#xD;
             testing to prove negative status is not required for enrollment unless it is deemed&#xD;
             necessary for usual medical care of the patient&#xD;
&#xD;
          -  Patients who have an active uncontrolled infection defined as:&#xD;
&#xD;
               -  Positive bacterial blood culture within 48 hours of study enrollment;&#xD;
&#xD;
               -  Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with&#xD;
                  clinical signs of infection; fever that is determined to be due to tumor burden&#xD;
                  is allowed if patients have documented negative blood cultures for at least 48&#xD;
                  hours prior to enrollment and no concurrent signs or symptoms of active infection&#xD;
                  or hemodynamic instability&#xD;
&#xD;
               -  A positive fungal culture within 30 days of study enrollment or active therapy&#xD;
                  for presumed invasive fungal infection&#xD;
&#xD;
               -  Patients may be receiving IV or oral antibiotics to complete a course of therapy&#xD;
                  for a prior documented infection as long as cultures have been negative for at&#xD;
                  least 48 hours and signs or symptoms of active infection have resolved; for&#xD;
                  patients with clostridium (C.) difficile diarrhea, at least 72 hours of&#xD;
                  antibacterial therapy must have elapsed and stools must have normalized to&#xD;
                  baseline&#xD;
&#xD;
               -  Active viral or protozoal infection requiring IV treatment&#xD;
&#xD;
          -  Patients known to have one of the following concomitant genetic syndromes: Bloom&#xD;
             syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman&#xD;
             (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome&#xD;
&#xD;
          -  There have been no human studies of inotuzumab ozogamicin in pregnant women and no&#xD;
             reports of exposure in utero; based on nonclinical safety studies, inotuzumab&#xD;
             ozogamicin has the potential to impair human male and female fertility and to&#xD;
             adversely affect human embryo fetal development; women of childbearing potential&#xD;
             should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin;&#xD;
             there is no information regarding the presence of inotuzumab ozogamicin in human milk,&#xD;
             the effects on the breast-fed infant, or the effects on milk production; because of&#xD;
             the potential for adverse reactions in breast-fed infants, women should not&#xD;
             breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months&#xD;
             after the final dose&#xD;
&#xD;
               -  Female patients of childbearing potential are not eligible unless a negative&#xD;
                  pregnancy test result has been obtained within 7 days prior to enrollment&#xD;
&#xD;
               -  Female patients who are sexually active and of reproductive potential are not&#xD;
                  eligible unless they agree to use an effective contraceptive method for the&#xD;
                  duration of their study participation and for 8 months after the last dose of&#xD;
                  inotuzumab ozogamicin&#xD;
&#xD;
               -  Men with female partners of childbearing potential should use effective&#xD;
                  contraception during treatment with inotuzumab ozogamicin and for at least 5&#xD;
                  months after the last dose of inotuzumab ozogamicin&#xD;
&#xD;
               -  Lactating females are not eligible unless they agree not to breastfeed their&#xD;
                  infants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen M O'Brien</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>205-638-9285</phone>
      <email>oncologyresearch@peds.uab.edu</email>
    </contact>
    <investigator>
      <last_name>Matthew A. Kutny</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Alaska Medical Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Brenda J. Wittman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner Children's at Desert</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>480-412-3100</phone>
    </contact>
    <investigator>
      <last_name>Joseph C. Torkildson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Phoenix Childrens Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>602-546-0920</phone>
    </contact>
    <investigator>
      <last_name>Dana B. Salzberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center - Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3591</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>501-364-7373</phone>
    </contact>
    <investigator>
      <last_name>David L. Becton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Downey Medical Center</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>626-564-3455</phone>
    </contact>
    <investigator>
      <last_name>Robert M. Cooper</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>909-558-4050</phone>
    </contact>
    <investigator>
      <last_name>Albert Kheradpour</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-361-4110</phone>
    </contact>
    <investigator>
      <last_name>Leo Mascarenhas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>310-423-8965</phone>
    </contact>
    <investigator>
      <last_name>Fataneh (Fae) Majlessipour</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Valley Children's Hospital</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93636</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCSF Benioff Children's Hospital Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>510-428-3324</phone>
      <email>Carla.Golden@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Carla B. Golden</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Aarati V. Rao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>714-509-8646</phone>
      <email>oncresearch@choc.org</email>
    </contact>
    <investigator>
      <last_name>Elyssa M. Rubin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-694-0012</phone>
      <email>ccto-office@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Jay Michael S. Balagtas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sutter Medical Center Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>Melanie.Cook@sutterhealth.org</email>
    </contact>
    <investigator>
      <last_name>Yung S. Yim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-734-3089</phone>
    </contact>
    <investigator>
      <last_name>Marcio H. Malogolowkin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>858-966-5934</phone>
    </contact>
    <investigator>
      <last_name>William D. Roberts</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSF Medical Center-Mission Bay</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-827-3222</phone>
      <email>cancertrials@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Elliot Stieglitz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-764-5056</phone>
      <email>josh.b.gordon@nsmtp.kp.org</email>
    </contact>
    <investigator>
      <last_name>Kelly W. Maloney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-839-6000</phone>
    </contact>
    <investigator>
      <last_name>Jennifer J. Clark</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>860-545-9981</phone>
    </contact>
    <investigator>
      <last_name>Michael S. Isakoff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfred I duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Emi H. Caywood</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>202-884-2549</phone>
    </contact>
    <investigator>
      <last_name>Jeffrey S. Dome</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Golisano Children's Hospital of Southwest Florida</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>239-343-5333</phone>
      <email>molly.arnstrom@leehealth.org</email>
    </contact>
    <investigator>
      <last_name>Emad K. Salman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>352-273-8010</phone>
      <email>cancer-center@ufl.edu</email>
    </contact>
    <investigator>
      <last_name>William B. Slayton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital/Joe DiMaggio Children's Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>954-265-1847</phone>
      <email>OHR@mhs.net</email>
    </contact>
    <investigator>
      <last_name>Iftikhar Hanif</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Clinic-Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Emi H. Caywood</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-624-2778</phone>
    </contact>
    <investigator>
      <last_name>Ziad A. Khatib</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>407-303-2090</phone>
      <email>FH.Cancer.Research@flhosp.org</email>
    </contact>
    <investigator>
      <last_name>Fouad M. Hajjar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Emi H. Caywood</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins All Children's Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's Hospital/Children's Hospital-Tampa</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>813-357-0849</phone>
      <email>jennifer.manns@baycare.org</email>
    </contact>
    <investigator>
      <last_name>Don E. Eslin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Hospital</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>561-881-2815</phone>
    </contact>
    <investigator>
      <last_name>Muaz A. Alrazzak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta - Egleston</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>404-785-2025</phone>
      <email>Leann.Schilling@choa.org</email>
    </contact>
    <investigator>
      <last_name>Melinda G. Pauly</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>912-350-7887</phone>
      <email>Lorraine.OHara@hcahealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Andrew L. Pendleton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-983-6090</phone>
    </contact>
    <investigator>
      <last_name>Wade T. Kyono</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Martha M. Pacheco</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lurie Children's Hospital-Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-880-4562</phone>
    </contact>
    <investigator>
      <last_name>Joanna L. Weinstein</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-702-8222</phone>
      <email>cancerclinicaltrials@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Gabrielle Lapping-Carr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>708-226-4357</phone>
    </contact>
    <investigator>
      <last_name>Eugene Suh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Jude Midwest Affiliate</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-226-4343</phone>
    </contact>
    <investigator>
      <last_name>Prerna Kumar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-545-7929</phone>
    </contact>
    <investigator>
      <last_name>Gregory P. Brandt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-248-1199</phone>
    </contact>
    <investigator>
      <last_name>Sandeep Batra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Vincent Indianapolis Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Blank Children's Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>515-241-8912</phone>
      <email>samantha.mallory@unitypoint.org</email>
    </contact>
    <investigator>
      <last_name>Samantha L. Mallory</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa/Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-237-1225</phone>
    </contact>
    <investigator>
      <last_name>David S. Dickens</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky/Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>859-257-3379</phone>
    </contact>
    <investigator>
      <last_name>James T. Badgett</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Norton Children's Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>502-629-5500</phone>
      <email>CancerResource@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Ashok B. Raj</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CHResearch@lcmchealth.org</email>
    </contact>
    <investigator>
      <last_name>Lolie C. Yu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>504-842-8084</phone>
      <email>Elisemarie.curry@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>Craig Lotterman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Maine Children's Cancer Program</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-396-7581</phone>
      <email>sverwys@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Eric C. Larsen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-601-6120</phone>
      <email>pridgely@lifebridgehealth.org</email>
    </contact>
    <investigator>
      <last_name>Jason M. Fixler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Kenneth J. Cohen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tufts Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-442-3324</phone>
    </contact>
    <investigator>
      <last_name>Melissa A. Burns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center - University Campus</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>508-856-3216</phone>
      <email>cancer.research@umassmed.edu</email>
    </contact>
    <investigator>
      <last_name>Stefanie R. Lowas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>C S Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-865-1125</phone>
    </contact>
    <investigator>
      <last_name>Emily B. Walling</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Michigan State University Clinical Center</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824-7016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>517-975-9547</phone>
    </contact>
    <investigator>
      <last_name>Laura E. Agresta</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital at Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beaumont Children's Hospital-Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>248-551-7695</phone>
    </contact>
    <investigator>
      <last_name>Laura K. Gowans</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota - Minneapolis</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>612-813-5193</phone>
    </contact>
    <investigator>
      <last_name>Michael K. Richards</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Minnesota/Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>612-624-2620</phone>
    </contact>
    <investigator>
      <last_name>Peter M. Gordon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Asmaa Ferdjallah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>601-815-6700</phone>
    </contact>
    <investigator>
      <last_name>Betty L. Herrington</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Columbia Regional</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Barbara A. Gruner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospitals and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>816-302-6808</phone>
      <email>rryan@cmh.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin F. Ginn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardinal Glennon Children's Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>314-268-4000</phone>
    </contact>
    <investigator>
      <last_name>William S. Ferguson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeffrey A. Magee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>314-251-7066</phone>
    </contact>
    <investigator>
      <last_name>Robin D. Hanson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital and Medical Center of Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-955-3949</phone>
    </contact>
    <investigator>
      <last_name>Jill C. Beck</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-559-6941</phone>
      <email>unmcrsa@unmc.edu</email>
    </contact>
    <investigator>
      <last_name>Don W. Coulter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunrise Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases/Cure 4 the Kids Foundation</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Summerlin Hospital Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-639-6918</phone>
      <email>cancer.research.nurse@dartmouth.edu</email>
    </contact>
    <investigator>
      <last_name>Angela Ricci</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-971-5900</phone>
    </contact>
    <investigator>
      <last_name>Kathryn L. Laurie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Peter's University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>732-745-8600</phone>
      <phone_ext>6163</phone_ext>
      <email>kcovert@saintpetersuh.com</email>
    </contact>
    <investigator>
      <last_name>Nibal A. Zaghloul</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>732-235-8675</phone>
    </contact>
    <investigator>
      <last_name>Archana Sharma</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-926-7230</phone>
      <email>Christine.Kosmides@rwjbh.org</email>
    </contact>
    <investigator>
      <last_name>Teena Bhatla</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's Regional Medical Center</name>
      <address>
        <city>Paterson</city>
        <state>New Jersey</state>
        <zip>07503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-754-2207</phone>
      <email>HallL@sjhmc.org</email>
    </contact>
    <investigator>
      <last_name>Alissa Kahn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>518-262-5513</phone>
    </contact>
    <investigator>
      <last_name>Lauren R. Weintraub</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-765-2500</phone>
    </contact>
    <investigator>
      <last_name>Mahmut Y. Celiker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-767-9355</phone>
      <email>askroswell@roswellpark.org</email>
    </contact>
    <investigator>
      <last_name>Clare J. Twist</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-263-4432</phone>
      <email>cancertrials@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Chana L. Glasser</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Steven and Alexandra Cohen Children's Medical Center of New York</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-470-3460</phone>
    </contact>
    <investigator>
      <last_name>Julie I. Krystal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center at NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CancerTrials@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Elizabeth A. Raetz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pallavi M. Pillai</last_name>
      <email>pallavi.madhusoodhan@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Pallavi M. Pillai</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Kavitha Ramaswamy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-862-2215</phone>
    </contact>
    <investigator>
      <last_name>Laura E. Hogan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>State University of New York Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>315-464-5476</phone>
    </contact>
    <investigator>
      <last_name>Philip M. Monteleone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mission Hospital</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>828-213-7055</phone>
      <email>NCDV.ResearchRegulatory@HCAHealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Douglas J. Scothorn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-275-3853</phone>
    </contact>
    <investigator>
      <last_name>Lars M. Wagner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>336-713-6771</phone>
    </contact>
    <investigator>
      <last_name>Thomas W. McLean</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Broadway Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>701-323-5760</phone>
      <email>OncologyClinicalTrialsFargo@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Samuel J. Milanovich</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Medical Center of Akron</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>330-543-3193</phone>
    </contact>
    <investigator>
      <last_name>Erin Wright</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>513-636-2799</phone>
      <email>cancer@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Maureen M. O'Brien</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-223-8100</phone>
      <email>TaussigResearch@ccf.org</email>
    </contact>
    <investigator>
      <last_name>Rabi Hanna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>614-722-6039</phone>
      <email>Melinda.Triplet@nationwidechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Mark A. Ranalli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dayton Children's Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-228-4055</phone>
    </contact>
    <investigator>
      <last_name>Mukund G. Dole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>419-824-1842</phone>
      <email>PCIOncResearch@promedica.org</email>
    </contact>
    <investigator>
      <last_name>Jamie L. Dargart</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>405-271-8777</phone>
      <email>ou-clinical-trials@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Rene Y. McNall-Knapp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Legacy Emanuel Children's Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-413-2560</phone>
    </contact>
    <investigator>
      <last_name>Janice F. Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-494-1080</phone>
      <email>trials@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Bill H. Chang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Cedar Crest</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>610-402-9543</phone>
      <email>Morgan_M.Horton@lvhn.org</email>
    </contact>
    <investigator>
      <last_name>Jacob A. Troutman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>570-271-5251</phone>
      <email>HemonCCTrials@geisinger.edu</email>
    </contact>
    <investigator>
      <last_name>Jagadeesh Ramdas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn State Children's Hospital</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>717-531-6012</phone>
    </contact>
    <investigator>
      <last_name>Lisa M. McGregor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>267-425-5544</phone>
      <email>CancerTrials@email.chop.edu</email>
    </contact>
    <investigator>
      <last_name>Susan R. Rheingold</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Christopher's Hospital for Children</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-427-8991</phone>
    </contact>
    <investigator>
      <last_name>Gregory E. Halligan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-692-8570</phone>
      <email>jean.tersak@chp.edu</email>
    </contact>
    <investigator>
      <last_name>Andrew Bukowinski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>401-444-1488</phone>
    </contact>
    <investigator>
      <last_name>Jennifer J. Welch</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>843-792-9321</phone>
      <email>hcc-clinical-trials@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Jacqueline M. Kraveka</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Richland Hospital</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-241-6251</phone>
    </contact>
    <investigator>
      <last_name>Stuart L. Cramer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BI-LO Charities Children's Cancer Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-241-6251</phone>
    </contact>
    <investigator>
      <last_name>Aniket Saha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>605-312-3320</phone>
      <email>OncologyClinicalTrialsSF@SanfordHealth.org</email>
    </contact>
    <investigator>
      <last_name>Kayelyn J. Wagner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>T C Thompson Children's Hospital</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>423-778-7289</phone>
    </contact>
    <investigator>
      <last_name>Benjamin A. Mixon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>East Tennessee Childrens Hospital</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>865-541-8266</phone>
    </contact>
    <investigator>
      <last_name>Susan E. Spiller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-226-4343</phone>
      <email>referralinfo@stjude.org</email>
    </contact>
    <investigator>
      <last_name>Sima C. Jeha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at TriStar Centennial</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>615-342-1919</phone>
    </contact>
    <investigator>
      <last_name>Jennifer A. Domm</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University/Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-811-8480</phone>
    </contact>
    <investigator>
      <last_name>Debra L. Friedman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dell Children's Medical Center of Central Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>512-628-1902</phone>
      <email>TXAUS-DL-SFCHemonc.research@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Shannon M. Cohn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Driscoll Children's Hospital</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>361-694-5311</phone>
      <email>Crystal.DeLosSantos@dchstx.org</email>
    </contact>
    <investigator>
      <last_name>Nkechi I. Mba</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>972-566-5588</phone>
    </contact>
    <investigator>
      <last_name>Stanton C. Goldman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Tamra L. Slone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>El Paso Children's Hospital</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>915-298-5444</phone>
      <email>ranjan.bista@ttuhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Ranjan Bista</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>682-885-2103</phone>
      <email>CookChildrensResearch@cookchildrens.org</email>
    </contact>
    <investigator>
      <last_name>Kenneth M. Heym</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>713-798-1354</phone>
      <email>burton@bcm.edu</email>
    </contact>
    <investigator>
      <last_name>Joanna S. Yi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Covenant Children's Hospital</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Kishor M. Bhende</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UMC Cancer Center / UMC Health System</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79415</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>806-775-8590</phone>
    </contact>
    <investigator>
      <last_name>Erin K. Barr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-704-2894</phone>
      <email>bridget.medina@christushealth.org</email>
    </contact>
    <investigator>
      <last_name>Timothy C. Griffin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Methodist Children's Hospital of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-575-6240</phone>
      <email>Vinod.GidvaniDiaz@hcahealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Jose M. Esquilin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-450-3800</phone>
      <email>phoresearchoffice@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>Anne-Marie R. Langevin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>801-585-5270</phone>
    </contact>
    <investigator>
      <last_name>Luke D. Maese</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Vermont and State Agricultural College</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>802-656-8990</phone>
      <email>rpo@uvm.edu</email>
    </contact>
    <investigator>
      <last_name>Jessica L. Heath</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>434-243-6303</phone>
      <email>uvacancertrials@hscmail.mcc.virginia.edu</email>
    </contact>
    <investigator>
      <last_name>William C. Petersen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>703-208-6650</phone>
      <email>Stephanie.VanBebber@inova.org</email>
    </contact>
    <investigator>
      <last_name>Robin Y. Dulman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of The King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>757-668-7243</phone>
      <email>CCBDCresearch@chkd.org</email>
    </contact>
    <investigator>
      <last_name>Eric J. Lowe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-987-2000</phone>
    </contact>
    <investigator>
      <last_name>Sarah E. Leary</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center and Children's Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-228-6618</phone>
      <email>HopeBeginsHere@providence.org</email>
    </contact>
    <investigator>
      <last_name>Judy L. Felgenhauer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Virginia University Healthcare</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>304-293-7374</phone>
      <email>cancertrialsinfo@hsc.wvu.edu</email>
    </contact>
    <investigator>
      <last_name>Ashley E. Meyer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>HIMA San Pablo Oncologic Hospital</name>
      <address>
        <city>Caguas</city>
        <zip>00726</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>787-653-3434</phone>
    </contact>
    <investigator>
      <last_name>Jhon A. Guerra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Asparaginase</mesh_term>
    <mesh_term>Pegaspargase</mesh_term>
    <mesh_term>Inotuzumab Ozogamicin</mesh_term>
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Levoleucovorin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02981628
org study id: AALL1621
secondary id: NCI-2016-01494
secondary id: AALL1621
secondary id: AALL1621
secondary id: U10CA180886
nct id: NCT02981628
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients
      with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come
      back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a
      monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab
      attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill
      them.
PRIMARY OBJECTIVE:

      I. To determine the morphologic response rate (complete response [CR] + complete response
      with incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab
      ozogamicin in children with relapsed or refractory CD22+ B acute lymphoblastic leukemia
      (B-ALL). (Cohort 1)

      SECONDARY OBJECTIVES:

      I. To determine the CR/CRi rate following 2 cycles of inotuzumab ozogamicin therapy. (Cohort
      1) II. To determine the safety of single agent inotuzumab ozogamicin administered at the
      adult recommended phase 2 dose (RP2D) to pediatric patients with relapsed or refractory CD22+
      B-ALL. (Cohort 1) III. To determine the level of minimal residual disease (MRD) by flow
      cytometry in responding patients. (Cohorts 1 and 2) IV. To determine the incidence, severity,
      and outcomes of sinusoidal obstruction syndrome (SOS) of the liver in patients during
      inotuzumab ozogamicin therapy and following subsequent treatment, including myeloablative
      hematopoietic stem cell transplantation (HSCT). (Cohorts 1 and 2) V. To estimate the 3-year
      event-free survival (EFS), 3-year overall survival (OS), and among responders, duration of
      CR/CRi for pediatric patients with relapsed or refractory B-ALL treated with inotuzumab
      ozogamicin. (Cohort 1) VI. To describe inotuzumab ozogamicin pharmacokinetics and
      immunogenicity in pediatric patients in the presence of overt leukemia and in remission.
      (Cohort 1) VII. To determine the safe and tolerable dose of inotuzumab ozogamicin in
      combination with the augmented modified Berlin-Frankfurt-Munster (mBFM) consolidation
      chemotherapy backbone. (Cohort 2)

      EXPLORATORY OBJECTIVES:

      I. To describe the levels of leukemic blast CD22 surface expression and site density, and to
      explore the correlation with cytogenetics and clinical outcomes after treatment with
      inotuzumab ozogamicin. (Cohorts 1 and 2) II. To explore potential mechanisms of resistance to
      inotuzumab ozogamicin therapy including CD22 splice variants and intracellular signaling
      pathways. (Cohorts 1 and 2) III. To explore the impact of inotuzumab ozogamicin on humoral
      immune function and peripheral B cell populations. (Cohorts 1 and 2) IV. To describe the
      level of MRD by next-generation high-throughput sequencing (HTS) techniques which may detect
      low level leukemic blast populations that have altered CD22 expression. (Cohorts 1 and 2) V.
      To prospectively explore candidate SOS biomarkers including the endothelial marker of
      inflammation Angiopoietin 2 (Ang2) and the hepatic specific complement marker L-ficolin.
      (Cohorts 1 and 2) VI. To explore the use of prophylactic ursodeoxycholic acid (UDCA) to
      prevent hepatic damage and SOS during inotuzumab ozogamicin therapy and subsequent HSCT.
      (Cohorts 1 and 2) VII. To describe the interaction between inotuzumab ozogamicin and chimeric
      antigen receptor (CAR) T cell therapy before or after treatment with inotuzumab ozogamicin.
      (Cohorts 1 and 2) VIII. To estimate the CR/CRi rate following one cycle of inotuzumab
      ozogamicin plus augmented mBFM consolidation chemotherapy (first 42 days) and following 2
      cycles within the confines of a pilot study. (Cohort 2)

      OUTLINE: Patients are assigned to 1 of 2 cohorts.

      COHORT I: Patients receive inotuzumab ozogamicin intravenously (IV) over 60 minutes on days
      1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence
      of disease progression or unacceptable toxicity. (COMPLETE)

      COHORT II: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15.
      Patients also receive cyclophosphamide IV over 30-60 on day 1; cytarabine IV over 1-30
      minutes or subcutaneously (SC) on days 1-4 and 8-11; leucovorin calcium orally (PO) or IV on
      days 2, 9, 16, 23 and 37 of cycle 1 and days 9 and 37 of cycle 2; pegaspargase or
      calaspargase pegol IV over 1-2 hours or pegaspargase intramuscularly (IM) on day 22; and
      vincristine IV on days 22 and 29. Patients receive methotrexate intrathecally (IT) on days 1,
      8 and 36 of cycle 1 and day 36 of cycle 2 for CNS 1 patients, days 1, 8, 15, 22 and 36 of
      cycle 1, and day 36 of cycle 2 for CNS 2 patients. CNS 3 patients receive methotrexate
      intrathecal triple therapy (ITT) IT on days 1, 8, 15, 22 and 36 of cycle 1 and days 8 and 36
      of cycle 2. There will be 3 dose levels. If excessive toxicity is observed at dose level 1,
      the dosing of inotuzumab ozogamicin will be decreased for dose level -1. If excessive
      toxicity is observed at this dose, then for dose level -2, pegaspargase/calaspargase pegol
      will be omitted. Treatment repeats every 42 days for up to 2 cycles in the absence of disease
      progression or unacceptable toxicity. Patients undergo bone marrow aspiration or biopsy,
      lumbar puncture, and blood sample collection throughout the trial. Patients also undergo
      imaging on screening and on study.

      After completion of study treatment, patients are followed up at 30 days, every 3 months for
      1 year, and then yearly for 4 years.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1)
time frame: Up to 28 days
description: The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. A one-sided lower 95% Agresti-Coull confidence limit will be calculated.
measure: Morphologic response (CR + CRi) following 2 cycles of inotuzumab ozogamicin therapy (Cohort1)
time frame: Up to 56 days
description: The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response.
measure: Incidence of dose-limiting toxicities at recommended phase II dose (RP2D) (Cohort 1)
time frame: During Cycle 1, up to 28 days
description: Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
measure: Level of minimal residual disease (MRD) assessed in bone marrow by flow cytometry (Cohort 1 and 2)
time frame: Up to 2 cycles
description: MRD negativity rates (< 0.01% detectable leukemia cells) will be estimated.
measure: Incidence of adverse events of sinusoidal obstruction syndrome (SOS) of liver (Cohort 1 and 2)
time frame: Up to 1 year from last dose of Inotuzumab ozogamicin
description: Evaluated according to NCI CTCAE version 5.0. The incidence of SOS of the liver in patients during inotuzumab ozogamicin therapy and following subsequent treatment including myeloablative hematopoietic cell transplantation (HSCT) will be described.
measure: Event free survival (EFS) (Cohort 1)
time frame: From study entry to first event (induction failure, induction death, relapse, second malignancy, remission death), or date of last follow-up for event free subjects, assessed up to 3 years
description: The EFS rate will be estimated using Kaplan Meier approach.
measure: Overall survival (OS) (Cohort 1)
time frame: From the time from study entry to death or date of last follow-up, assessed up to 3 years
description: The OS rate will be estimated using Kaplan Meier approach.
measure: Duration of CR, CRi (Cohort 1)
time frame: Up to 3 years
description: Among responding patients, three-year complete continuous response will also be estimated using duration of CR/CRi for the overall responding group and stratified by whether or not the patients proceed to HSCT.
measure: Pharmacokinetic (PK) parameters, i.e., inotuzumab ozogamicin trough levels (Cohort 1)
time frame: Cycles 1 and 2 (each cycle is 28 days)
description: Inotuzumab ozogamicin trough levels (ng/mL) will be determined in serum by validated, high sensitivity liquid chromatography-mass spectrometry (LCMS) assays. Descriptive summary statistics will be provided for the trough levels at scheduled visits for Cycles 1 and 2.
measure: Immunogenicity (Cohort 1)
time frame: Cycles 1 and 2
description: Enhanced chemiluminescence (ECL) and cell-based assays will be used to detect anti-drug antibodies and neutralizing antibodies to inotuzumab ozogamicin in serum. Inotuzumab ozogamicin trough levels will be compared between patients with and without antibodies.
measure: Incidence of dose-limiting toxicities at the selected dose level of inotuzumab ozogamicin in combination with the augmented modified Berlin-Frankfurt-Munster (mBFM) consolidation chemotherapy (Cohort 2)
time frame: Up to cycle 1 (each cycle is 42 days)
description: Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. For a given reporting period, a patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient.
measure: Changes in CD22 surface expression (Cohorts 1 and 2)
time frame: Baseline, post Cycle 1, and at time of relapse
description: Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 expression pre and post-inotuzumab ozogamicin. Specifically, samples will be evaluated for change in CD22 expression that occurs over time to study the role of CD22 expression as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 expression and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).
measure: Change in CD22 site density (Cohorts 1 and 2)
time frame: Baseline, post Cycle 1, and at time of relapse
description: Exploratory analysis of CD22 will focus primarily on the comparison of paired pre-treatment and post-treatment samples at the following times, 1) End of cycle 1 and 2) at relapse to evaluate for changes in CD22 site density pre and post-inotuzumab ozogamicin. Samples will be evaluated for any change in CD22 site density that occurs over time and to evaluate for the emergence of a CD22 "dim" or "negative" population to study the role of CD22 site density as it relates to resistance to therapy or mechanism for relapse. Correlation between changes in CD22 site density and patient's clinical response to inotuzumab ozogamicin as well as cytogenetic/molecular features will be described, in particular to explore the association of CD22-negative subpopulations in patients with KMT2A-rearranged acute lymphoblastic leukemia (ALL).
measure: Leukemic blast CD22 splice variants (Cohorts 1 and 2)
time frame: Baseline, post-Cycle 1, and at time of relapse
description: Will be analyzed by ribonucleic acid-sequencing (RNA-Seq). The MAJIQ and VOILA software will be used to identify splicing variations in CD22 from RNA Seq and to quantitate the percent spliced in (PSI) of the alternative exons. CD22 protein levels will be determined by immunoblotting of whole cell protein lysates using several anti-CD22 antibodies recognizing either extracellular or intracellular domains. Both protein sizes and preservation of individual epitopes will be assessed and correlated with alterations in exon inclusion.
measure: Intracellular signaling pathways in leukemic blasts treated with inotuzumab ozogamicin (Cohorts 1 and 2)
time frame: Baseline up to 5 years
description: Peripheral blood samples will be evaluated by comprehensive protein profiling using CyTOF panels for the two major areas of analyses, surface immunophenotyping to assess the developmental stage of both normal and abnormal B cells and measure their responses to inotuzumab ozogamicin , as well as intracellular epitopes to assess the cellular consequences of treatment with inotuzumab ozogamicin. Exploratory analysis will be performed using Cytobank software tools (viSNE, SPADE and CITRUS) for subpopulations clustering, dimensionality reduction and hierarchical organization.
measure: Changes in peripheral blood absolute B cell numbers and maturation of developing B cell populations with inotuzumab ozogamicin therapy (Cohorts 1 and 2)
time frame: Baseline up to 5 years
description: Descriptive statistics will be used to characterize patterns of B-cell development including selective loss of subsets. Changes in B cell number and subsets will be described, and exploratory analysis will be conducted to assess their correlation with clinical features including immunoglobulin levels, occurrence of infections, and need for intravenous immunoglobulin (IVIG) replacement during inotuzumab ozogamicin therapy.
measure: Level of MRD by next-generation high-throughput sequencing (HTS) techniques (Cohorts 1 and 2)
time frame: Up to 2 cycles
description: Compared to MRD measured by flow cytometry. MRD levels at each bone marrow evaluation time point will be measured by standard flow cytometry (MRD-negative defined as < 0.01% or 1 leukemic cell in 10-4 nucleated cells). At the end of cycles 1 and 2, MRD will also be assessed by HTS. The correlation between the measurements with each technique will be described and the sensitivity of flow-based MRD methodology in the setting of CD22-targeted therapy will be explored.
measure: Serum levels of candidate SOS biomarkers Ang2 and L ficolin (Cohorts 1 and 2)
time frame: Up to 12 months from last dose of inotuzumab ozogamicin
description: Correlated with clinical development of SOS. Descriptive statistics will be used to characterize clinical features of patients experiencing SOS. L-ficolin and Ang2 absolute levels and change in level over time with inotuzumab ozogamicin exposure will be evaluated and correlated with development of SOS. Biomarker levels will be compared using simple comparative statistics between subgroups.
measure: Incidence of SOS in patients who receive prophylaxis with ursodeoxycholic acid (UDCA) during inotuzumab ozogamicin therapy (Cohorts 1 and 2)
time frame: Up to 12 months from last dose of inotuzumab ozogamicin
description: Descriptive statistics will be used to characterize clinical features of patients experiencing SOS, potential clinical risk factors, and the impact of ursodeoxycholic acid prophylaxis.
measure: Interaction between CAR- T therapy and inotuzumab ozogamicin (Cohorts 1 and 2)
time frame: Up to 5 years
description: Will be evaluated by incidence of hematologic DLT in patients with CAR-T therapy prior to inotuzumab ozogamicin, incidence of post-inotuzumab ozogamicin CAR-T therapy, time to CAR-T therapy after inotuzumab ozogamicin, and B-cell recovery prior to CAR-T therapy after inotuzumab ozogamicin. Will be summarized using descriptive statistics.
measure: Morphologic response (CR/CRi) (Cohort 2)
time frame: Up to 2 cycles (each cycle is 42 days)
description: Will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. Analysis will be mostly descriptive.
arm group label: Cohort I (inotuzumab ozogamicin)
arm group type: Experimental
description: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. (COMPLETE)
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
arm group type: Experimental
description: See Detailed Description
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo blood sample collection
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Procedure
intervention name: Bone Marrow Aspiration and Biopsy
description: Undergo a bone marrow aspiration and biopsy
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
intervention type: Drug
intervention name: Calaspargase Pegol
description: Given IV
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)
other name: Asparlas
other name: Calaspargase Pegol-mknl
other name: EZN-2285
other name: SC-PEG E. Coli L-Asparaginase
other name: Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: (-)-Cyclophosphamide
other name: 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
other name: Carloxan
other name: Ciclofosfamida
other name: Ciclofosfamide
other name: Cicloxal
other name: Clafen
other name: Claphene
other name: CP monohydrate
other name: CTX
other name: CYCLO-cell
other name: Cycloblastin
other name: Cycloblastine
other name: Cyclophospham
other name: Cyclophosphamid monohydrate
other name: Cyclophosphamide Monohydrate
other name: Cyclophosphamidum
other name: Cyclophosphan
other name: Cyclophosphane
other name: Cyclophosphanum
other name: Cyclostin
other name: Cyclostine
other name: Cytophosphan
other name: Cytophosphane
other name: Cytoxan
other name: Fosfaseron
other name: Genoxal
other name: Genuxal
other name: Ledoxina
other name: Mitoxan
other name: Neosar
other name: Revimmune
other name: Syklofosfamid
other name: WR- 138719
intervention type: Drug
intervention name: Cytarabine
description: Given IV or SC
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: .beta.-Cytosine arabinoside
other name: 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-.beta.-D-Arabinofuranosylcytosine
other name: 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-Beta-D-arabinofuranosylcytosine
other name: 1.beta.-D-Arabinofuranosylcytosine
other name: 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
other name: 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
other name: Alexan
other name: Ara-C
other name: ARA-cell
other name: Arabine
other name: Arabinofuranosylcytosine
other name: Arabinosylcytosine
other name: Aracytidine
other name: Aracytin
other name: Aracytine
other name: Beta-Cytosine Arabinoside
other name: CHX-3311
other name: Cytarabinum
other name: Cytarbel
other name: Cytosar
other name: Cytosine Arabinoside
other name: Cytosine-.beta.-arabinoside
other name: Cytosine-beta-arabinoside
other name: Erpalfa
other name: Starasid
other name: Tarabine PFS
other name: U 19920
other name: U-19920
other name: Udicil
other name: WR-28453
intervention type: Procedure
intervention name: Diagnostic Imaging
description: Undergo imaging
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Medical Imaging
intervention type: Biological
intervention name: Inotuzumab Ozogamicin
description: Given IV
arm group label: Cohort I (inotuzumab ozogamicin)
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Besponsa
other name: CMC-544
other name: Way 207294
other name: WAY-207294
intervention type: Drug
intervention name: Leucovorin Calcium
description: Given PO or IV
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Adinepar
other name: Calcifolin
other name: Calcium (6S)-Folinate
other name: Calcium Folinate
other name: Calcium Leucovorin
other name: Calfolex
other name: Calinat
other name: Cehafolin
other name: Citofolin
other name: Citrec
other name: Citrovorum Factor
other name: Cromatonbic Folinico
other name: Dalisol
other name: Disintox
other name: Divical
other name: Ecofol
other name: Emovis
other name: Factor, Citrovorum
other name: Flynoken A
other name: Folaren
other name: Folaxin
other name: FOLI-cell
other name: Foliben
other name: Folidan
other name: Folidar
other name: Folinac
other name: Folinate Calcium
other name: folinic acid
other name: Folinic Acid Calcium Salt Pentahydrate
other name: Folinoral
other name: Folinvit
other name: Foliplus
other name: Folix
other name: Imo
other name: Lederfolat
other name: Lederfolin
other name: Leucosar
other name: leucovorin
other name: Rescufolin
other name: Rescuvolin
other name: Tonofolin
other name: Wellcovorin
intervention type: Procedure
intervention name: Lumbar Puncture
description: Undergo lumbar puncture
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: LP
other name: Spinal Tap
intervention type: Drug
intervention name: Methotrexate
description: Given IT
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Abitrexate
other name: Alpha-Methopterin
other name: Amethopterin
other name: Brimexate
other name: CL 14377
other name: CL-14377
other name: Emtexate
other name: Emthexat
other name: Emthexate
other name: Farmitrexat
other name: Fauldexato
other name: Folex
other name: Folex PFS
other name: Lantarel
other name: Ledertrexate
other name: Lumexon
other name: Maxtrex
other name: Medsatrexate
other name: Metex
other name: Methoblastin
other name: Methotrexate LPF
other name: Methotrexate Methylaminopterin
other name: Methotrexatum
other name: Metotrexato
other name: Metrotex
other name: Mexate
other name: Mexate-AQ
other name: MTX
other name: Novatrex
other name: Rheumatrex
other name: Texate
other name: Tremetex
other name: Trexeron
other name: Trixilem
other name: WR-19039
intervention type: Drug
intervention name: Pegaspargase
description: Given IV or IM
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: L-Asparaginase with Polyethylene Glycol
other name: Oncaspar
other name: Oncaspar-IV
other name: PEG-Asparaginase
other name: PEG-L-Asparaginase
other name: PEG-L-Asparaginase (Enzon - Kyowa Hakko)
other name: PEGLA
other name: Polyethylene Glycol L-Asparaginase
other name: Polyethylene Glycol-L-Asparaginase
intervention type: Drug
intervention name: Vincristine
description: Given IV
arm group label: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
other name: Leurocristine
other name: VCR
other name: Vincrystine
criteria: 
gender: All
minimum age: 1 Year
maximum age: 21 Years
healthy volunteers: No
last name: Maureen M O'Brien
role: Principal Investigator
affiliation: Children's Oncology Group
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Lymphoma, Non-Hodgkin
mesh term: Recurrence
mesh term: Calcium, Dietary
mesh term: Leucovorin
mesh term: Folic Acid
mesh term: Cytarabine
mesh term: Cyclophosphamide
mesh term: Methotrexate
mesh term: Vincristine
mesh term: Asparaginase
mesh term: Pegaspargase
mesh term: Inotuzumab Ozogamicin
mesh term: Calcium
mesh term: Levoleucovorin