<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/NCT04491370</url>
  </required_header>
  <id_info>
    <org_study_id>14357</org_study_id>
    <nct_id>NCT04491370</nct_id>
  </id_info>
  <brief_title>Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma</brief_title>
  <official_title>Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an&#xD;
      autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or&#xD;
      stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once&#xD;
      every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed,&#xD;
      patients will be followed every 4 months for about 2 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2021</start_date>
  <completion_date type="Anticipated">August 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the safety and tolerability of Polatuzumab vedotin (PV) immunoconjugate therapy post myeloablative conditioning (MAC) and autologous stem cell transplantation (AutoSCT) in patients with B-cell non-Hodgkin lymphoma (NHL).&#xD;
Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.&#xD;
To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to polatuzumab vedotin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EFS, PFS, and OS</measure>
    <time_frame>2 years</time_frame>
    <description>To measure event free survival (EFS), progression free survival (PFS) and overall survival (OS) in patients with B-cell NHL following MAC and AutoSCT and post AutoSCT PV maintenance therapy.&#xD;
All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII) for patients &gt; 21 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>2 years</time_frame>
    <description>To measure overall response rate (ORR) of PV in B-cell NHL patients who are in PR or SD post MAC AutoSCT.&#xD;
Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI,[24]) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII, [25]) for patients &gt; 21 years of age.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>B-cell Lymphoma</condition>
  <condition>Burkitt Lymphoma</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <condition>Follicular Lymphoma</condition>
  <condition>Mantle Cell Lymphoma</condition>
  <condition>Marginal Zone Lymphoma</condition>
  <condition>Transformed Non-Hodgkin Lymphoma</condition>
  <condition>Richter Syndrome</condition>
  <condition>Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Polatuzumab vedotin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety.&#xD;
Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable.&#xD;
Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polatuzumab vedotin</intervention_name>
    <description>All patients will receive a myeloablative conditioning regimens (BEAM or CBV, as selected by the treating physician) followed by autologous stem cell transplant (ASCT). All patients on this study will receive an autologous stem cell transplant (ASCT) on Day 0 followed by supportive care including the drugs sargarmostim and filgrastim until blood counts are stable. If a complete, partial, or stable response is achieved following ASCT, the patient will receive an IV dose of Polatuzumab Vedotin once every 21 days until he/she receives 8 doses.</description>
    <arm_group_label>Polatuzumab vedotin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular&#xD;
             Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular&#xD;
             Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma.&#xD;
&#xD;
          -  Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having&#xD;
             attained a CR, PR, or stable disease post reinduction therapy.&#xD;
&#xD;
          -  Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for&#xD;
             patients &gt; 16 years of age and Lansky for patients less than or equal to 16 years of&#xD;
             age. See Appendix I for performance score.&#xD;
&#xD;
          -  Life Expectancy Patients must have a life expectancy of &gt; 6 weeks.&#xD;
&#xD;
          -  Prior Therapy Patients must have fully recovered from the acute toxic effects of all&#xD;
             prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.&#xD;
&#xD;
               1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry&#xD;
                  onto this study (4 weeks if prior nitrosourea).&#xD;
&#xD;
               2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy&#xD;
                  with a biologic agent.&#xD;
&#xD;
          -  Organ Function Requirements&#xD;
&#xD;
        Adequate Renal Function Defined As:&#xD;
&#xD;
          -  Creatinine clearance or radioisotope GFR &gt; 60 mL/min/1.73 m2 or&#xD;
&#xD;
          -  A serum creatinine based on age/gender as follows:&#xD;
&#xD;
        Age Maximum Serum Creatinine (mg/dL) Male Female&#xD;
&#xD;
          -  12 to &lt; 13 years 1.2 1.2 13 to &lt; 16 years 1.5 1.4&#xD;
&#xD;
          -  16 years 1.7 1.4&#xD;
&#xD;
               -  Adequate Liver Function Defined As:&#xD;
&#xD;
                    -  Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for&#xD;
                       age, and&#xD;
&#xD;
                    -  SGOT (AST) or SGPT (ALT) &lt; 3 x upper limit of normal (ULN) for age for&#xD;
                       presumed hepatic leukemia or lymphoma.&#xD;
&#xD;
               -  Adequate Cardiac Function Defined As:&#xD;
&#xD;
                    -  Shortening fraction of &gt; 27% by echocardiogram, or&#xD;
&#xD;
                    -  Ejection fraction of &gt; 50% by radionuclide angiogram.&#xD;
&#xD;
               -  Adequate Pulmonary Function Defined As:&#xD;
&#xD;
                  • Normal respiratory rate for age and a pulse oximetry &gt; 94% on room air unless&#xD;
                  due to underlying malignancy.&#xD;
&#xD;
               -  Peripheral Blood Stem Cell Collection&#xD;
&#xD;
                  • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC&#xD;
                  collected and cryopreserved prior to start of myeloablative conditioning&#xD;
&#xD;
               -  All patients and/or their parents or legal guardians must sign a written informed&#xD;
                  consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient may not have had a prior stem cell transplant&#xD;
&#xD;
          -  Patients must not have active CNS lymphoma&#xD;
&#xD;
          -  Other concurrent investigational agents for treatment of B-cell lymphoma&#xD;
&#xD;
          -  Pregnancy and/or active Breast Feeding&#xD;
&#xD;
          -  Sexually active patients of reproductive potential are not eligible unless they have&#xD;
             agreed to use an effective contraceptive method for the duration of their study&#xD;
             participation.&#xD;
&#xD;
          -  Patient must not have an uncontrolled infection.&#xD;
&#xD;
          -  Patient must not have ≥ Grade 3 neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aliza Gardenswartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren Harrison, RN</last_name>
    <phone>6172857844</phone>
    <email>lauren_harrison@nymc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>New York Medical Center</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aliza Gardenswartz, MD</last_name>
      <email>aliza.gardenswartz@wmchealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>October 29, 2021</last_update_submitted>
  <last_update_submitted_qc>October 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</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>Burkitt Lymphoma</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polatuzumab vedotin</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/NCT04491370
org study id: 14357
nct id: NCT04491370
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an
      autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or
      stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once
      every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed,
      patients will be followed every 4 months for about 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability
time frame: 1 year
description: To evaluate the safety and tolerability of Polatuzumab vedotin (PV) immunoconjugate therapy post myeloablative conditioning (MAC) and autologous stem cell transplantation (AutoSCT) in patients with B-cell non-Hodgkin lymphoma (NHL).
Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0.
To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to polatuzumab vedotin.
measure: EFS, PFS, and OS
time frame: 2 years
description: To measure event free survival (EFS), progression free survival (PFS) and overall survival (OS) in patients with B-cell NHL following MAC and AutoSCT and post AutoSCT PV maintenance therapy.
All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII) for patients > 21 years of age.
measure: ORR
time frame: 2 years
description: To measure overall response rate (ORR) of PV in B-cell NHL patients who are in PR or SD post MAC AutoSCT.
Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI,[24]) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII, [25]) for patients > 21 years of age.
arm group label: Polatuzumab vedotin
arm group type: Experimental
description: Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety.
Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable.
Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.
intervention type: Drug
intervention name: Polatuzumab vedotin
description: All patients will receive a myeloablative conditioning regimens (BEAM or CBV, as selected by the treating physician) followed by autologous stem cell transplant (ASCT). All patients on this study will receive an autologous stem cell transplant (ASCT) on Day 0 followed by supportive care including the drugs sargarmostim and filgrastim until blood counts are stable. If a complete, partial, or stable response is achieved following ASCT, the patient will receive an IV dose of Polatuzumab Vedotin once every 21 days until he/she receives 8 doses.
arm group label: Polatuzumab vedotin
criteria: 
gender: All
minimum age: 12 Years
maximum age: 70 Years
healthy volunteers: No
last name: Aliza Gardenswartz, MD
role: Principal Investigator
affiliation: New York Medical College
last name: Lauren Harrison, RN
phone: 6172857844
email: lauren_harrison@nymc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Burkitt Lymphoma
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Hodgkin Disease
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Polatuzumab vedotin