xml: <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/NCT06040320</url>
    </required_header>
    <id_info>
      <org_study_id>202308116</org_study_id>
      <nct_id>NCT06040320</nct_id>
    </id_info>
    <brief_title>Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)</brief_title>
    <official_title>A Phase I/II Study of Frontline Therapy With Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Washington University School of Medicine</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will test polatuzumab vedotin in combination with rituximab in patients with&#xD;
        treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on&#xD;
        the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate&#xD;
        response rate of PTLD to single-agent rituximab. The hypothesis is that this combination&#xD;
        therapy will be safe, well-tolerated, and effective. If so, patients with PTLD will be able&#xD;
        to be spared the toxicity of anthracycline-based chemotherapy. Additionally, the role of the&#xD;
        tumor microenvironment and the role of anellovirus, a non-human pathogen virus, will be&#xD;
        explored as prognostic markers in PTLD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2031</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2026</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>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency and severity of treatment-related adverse events (AEs)</measure>
      <time_frame>From start of treatment through 30 days after completion of treatment (estimated to be 5-7 months)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of dose-limiting toxicities (DLTs) (Safety Lead-In Cohort only)</measure>
      <time_frame>From start of treatment through cycle 2 (estimated to be 42 days, each cycle is 21 days)</time_frame>
      <description>A dose-limiting toxicity (DLT) is defined as an occurrence of an adverse event delineated by the protocol that is at least possibly related to polatuzumab vedotin, rituximab, or the combination within Cycle 1 or Cycle 2.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of completion of the regimen</measure>
      <time_frame>Through completion of treatment (estimated to be 4-6 months)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complete metabolic response (CR) rate by PET/CT</measure>
      <time_frame>After cycle 2 (estimated to be day 42, each cycle is 21 days)</time_frame>
      <description>-Per Lugano Response Criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete metabolic response (CR) rate by PET/CT</measure>
      <time_frame>End of treatment (estimated to be between 4-6 months)</time_frame>
      <description>-Per Lugano Response Criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>End of treatment (estimated to be between 4-6 months)</time_frame>
      <description>Per Lugano Response Criteria&#xD;
  Overall Response Rate: The proportion of patients who have a complete or partial response to therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best overall response</measure>
      <time_frame>Through completion of treatment (estimated to be between 4-6 months)</time_frame>
      <description>Per Lugano Response Criteria&#xD;
  Best Overall Response: Best response recorded from start of treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>Through 5 years from completion of treatment (estimated to be between 64 and 66 months)</time_frame>
      <description>Per Lugano Response Criteria&#xD;
  Duration of Response: The time from onset of response to disease progression or death in patients who achieve complete or partial response.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Through 5 years from completion of treatment (estimated to be between 64 and 66 months)</time_frame>
      <description>Per Lugano Response Criteria&#xD;
  Progression-Free Survival: The time from initiation of treatment to the occurrence of disease progression or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Through 5 years from completion of treatment (estimated to be between 64 and 66 months)</time_frame>
      <description>-Overall Survival: The time from initiation of treatment to death.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Post-transplant Lymphoproliferative Disorder</condition>
    <arm_group>
      <arm_group_label>Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cycle 1 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  Day 8: rituximab&#xD;
  Day 15: rituximab&#xD;
  Cycle 2 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cycle 1 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  Day 8: rituximab&#xD;
  Day 15: rituximab&#xD;
  Cycle 2 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cycle 1 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  Day 8: rituximab&#xD;
  Day 15: rituximab&#xD;
  Cycle 2 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cycle 1 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  Day 8: rituximab&#xD;
  Day 15: rituximab&#xD;
  Cycle 2 (21 days)&#xD;
  Day 1: polatuzumab vedotin + rituximab&#xD;
  After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Polatuzumab vedotin</intervention_name>
      <description>Given at 1.8 mg/kg</description>
      <arm_group_label>Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))</arm_group_label>
      <other_name>Polivy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rituximab</intervention_name>
      <description>Given at 375 mg/m^2</description>
      <arm_group_label>Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))</arm_group_label>
      <other_name>Rituxan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CHP</intervention_name>
      <description>Cyclophosphamide (750 mg/m^2) + doxorubicin (50 mg/m^2) + prednisone (100 mg days 2-6)</description>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)</arm_group_label>
      <arm_group_label>Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Previously untreated biopsy-confirmed CD20-positive monomorphic post-transplant&#xD;
               lymphoproliferative disorder (or CD20-positive lymphoma associated with immune&#xD;
               deficiency) arising after solid organ or hematopoietic stem cell transplant. This may&#xD;
               be defined by either the 2016 World Health Organization classification of lymphoid&#xD;
               neoplasms or the 2022 International consensus Classification of Mature Lymphoid&#xD;
               Neoplasms or the 2022 World Health Organization classification.&#xD;
  &#xD;
            -  At least 18 years of age.&#xD;
  &#xD;
            -  ECOG performance status ≤ 3.&#xD;
  &#xD;
            -  Adequate hematologic and organ function (unless due to underlying lymphoma per the&#xD;
               investigator) as defined below:&#xD;
  &#xD;
                 -  Absolute neutrophil count ≥ 1.0 K/cumm&#xD;
  &#xD;
                 -  Platelets ≥ 75 K/cumm&#xD;
  &#xD;
                 -  Hemoglobin ≥ 8.0 g/dL&#xD;
  &#xD;
                 -  Total bilirubin &lt; 1.5 x IULN&#xD;
  &#xD;
                 -  AST(SGOT)/ALT(SGPT) &lt; 2.5 x IULN&#xD;
  &#xD;
                 -  Creatinine clearance &gt; 30 mL/min measured or by Cockcroft-Gault&#xD;
  &#xD;
            -  Note: Patients with extensive bone marrow involvement by lymphoma and/or&#xD;
               disease-related cytopenias may be enrolled if the following criteria are met:&#xD;
  &#xD;
                 -  ANC ≥ 0.5 K/cumm&#xD;
  &#xD;
                 -  Platelets ≥ 50 K/cumm&#xD;
  &#xD;
                 -  Hemoglobin ≥ 7.0 g/dL&#xD;
  &#xD;
            -  The effects of polatuzumab vedotin and rituximab on the developing human fetus are&#xD;
               unknown. For this reason, women of childbearing potential and men must agree to use&#xD;
               adequate contraception (hormonal or barrier method of birth control, abstinence) prior&#xD;
               to study entry and for the duration of study participation. Should a participant&#xD;
               become pregnant or suspect pregnancy while participating in this study, the&#xD;
               participant must inform the treating physician immediately.&#xD;
  &#xD;
            -  Ability to understand and willingness to sign an IRB approved written informed consent&#xD;
               document.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active central nervous system involvement with lymphoma / PTLD.&#xD;
  &#xD;
            -  Current grade ≥ 2 peripheral neuropathy.&#xD;
  &#xD;
            -  Current ejection fraction &lt; 40% on transthoracic echocardiogram or multigated&#xD;
               acquisition (MUGA) scan&#xD;
  &#xD;
            -  Subjects with history of concurrent second cancers requiring active, ongoing systemic&#xD;
               treatment with the following exceptions:&#xD;
  &#xD;
                 -  Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will&#xD;
                    not be excluded.&#xD;
  &#xD;
                 -  Patients with previous malignancies are eligible if disease-free for &gt; 2 years.&#xD;
  &#xD;
                 -  Patients on long term hormonal therapy to prevent recurrence of a prior cancer&#xD;
                    (e.g., hormonal therapy for breast cancer) will not be excluded.&#xD;
  &#xD;
            -  Currently receiving any other investigational agents or received any investigational&#xD;
               agents during the 4 weeks prior to the first dose of polatuzumab vedotin.&#xD;
  &#xD;
            -  A history of allergic reactions attributed to compounds of similar chemical or&#xD;
               biologic composition to polatuzumab vedotin, rituximab, or other agents used in the&#xD;
               study.&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
               infection (bacterial, fungal, viral, parasitic, or mycobacterial), interstitial lung&#xD;
               disease, active non-infectious pneumonitis, congestive heart failure NYHA grade ≥ 3,&#xD;
               unstable angina pectoris, or cardiac arrhythmia.&#xD;
  &#xD;
            -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative&#xD;
               serum or urine pregnancy test within 7 days prior to C1D1&#xD;
  &#xD;
            -  Patients with HIV are eligible provided the meet the following criteria:&#xD;
  &#xD;
                 -  On antiretroviral regimen and stable on that regimen&#xD;
  &#xD;
                 -  Healthy from an HIV perspective&#xD;
  &#xD;
                 -  CD4 count &gt; 250 cells/mcL&#xD;
  &#xD;
                 -  Minimal anticipated interactions or overlapping toxicity with polatuzumab vedotin&#xD;
                    or rituximab&#xD;
  &#xD;
                 -  HIV viral load &lt; 200 copies/mm3 by standard clinical assays&#xD;
  &#xD;
            -  Active hepatitis B infection.&#xD;
  &#xD;
                 -  Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B&#xD;
                    core antibody (HBcAb) positive must be negative for hepatitis B virus (HBV)&#xD;
                    polymerase chain reaction (PCR) to be eligible for study participation.&#xD;
  &#xD;
            -  Active hepatitis C infection.&#xD;
  &#xD;
                 -  Patients who are positive for hepatitis C virus (HCV) antibody must be negative&#xD;
                    for HCV by PCR to be eligible for study participation.&#xD;
  &#xD;
            -  Any serious medical condition or abnormality in clinical laboratory tests that, in the&#xD;
               investigator's judgment, precludes the patient's safe participation in and completion&#xD;
               of the study, or which could affect compliance with the protocol or interpretation of&#xD;
               results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neha Mehta-Shah, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Neha Mehta-Shah, M.D.</last_name>
      <phone>314-747-7510</phone>
      <email>mehta-n@wustl.edu</email>
    </overall_contact>
    <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>
      <contact>
        <last_name>Neha Mehta-Shah, M.D.</last_name>
        <phone>314-747-7510</phone>
        <email>mehta-n@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Neha Mehta-Shah, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Imran Nizamuddin, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Brad Kahl, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nancy Bartlett, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marianna Ruzinova, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fei Wan, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laura Flynn, PharmD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.siteman.wustl.edu</url>
      <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PTLD</keyword>
    <keyword>Non-Hodgkin's lymphoma</keyword>
    <keyword>Risk stratification</keyword>
    <keyword>Front-line</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoproliferative Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rituximab</mesh_term>
      <mesh_term>Polatuzumab vedotin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040320
  org study id: 202308116
  nct id: NCT06040320
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study will test polatuzumab vedotin in combination with rituximab in patients with
        treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on
        the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate
        response rate of PTLD to single-agent rituximab. The hypothesis is that this combination
        therapy will be safe, well-tolerated, and effective. If so, patients with PTLD will be able
        to be spared the toxicity of anthracycline-based chemotherapy. Additionally, the role of the
        tumor microenvironment and the role of anellovirus, a non-human pathogen virus, will be
        explored as prognostic markers in PTLD.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Frequency and severity of treatment-related adverse events (AEs)
  time frame: From start of treatment through 30 days after completion of treatment (estimated to be 5-7 months)
  measure: Number of dose-limiting toxicities (DLTs) (Safety Lead-In Cohort only)
  time frame: From start of treatment through cycle 2 (estimated to be 42 days, each cycle is 21 days)
  description: A dose-limiting toxicity (DLT) is defined as an occurrence of an adverse event delineated by the protocol that is at least possibly related to polatuzumab vedotin, rituximab, or the combination within Cycle 1 or Cycle 2.
  measure: Rate of completion of the regimen
  time frame: Through completion of treatment (estimated to be 4-6 months)
  measure: Complete metabolic response (CR) rate by PET/CT
  time frame: After cycle 2 (estimated to be day 42, each cycle is 21 days)
  description: -Per Lugano Response Criteria
  measure: Complete metabolic response (CR) rate by PET/CT
  time frame: End of treatment (estimated to be between 4-6 months)
  description: -Per Lugano Response Criteria
  measure: Overall response rate (ORR)
  time frame: End of treatment (estimated to be between 4-6 months)
  description: Per Lugano Response Criteria
  Overall Response Rate: The proportion of patients who have a complete or partial response to therapy.
  measure: Best overall response
  time frame: Through completion of treatment (estimated to be between 4-6 months)
  description: Per Lugano Response Criteria
  Best Overall Response: Best response recorded from start of treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
  measure: Duration of response
  time frame: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
  description: Per Lugano Response Criteria
  Duration of Response: The time from onset of response to disease progression or death in patients who achieve complete or partial response.
  measure: Progression-free survival (PFS)
  time frame: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
  description: Per Lugano Response Criteria
  Progression-Free Survival: The time from initiation of treatment to the occurrence of disease progression or death.
  measure: Overall survival (OS)
  time frame: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
  description: -Overall Survival: The time from initiation of treatment to death.
  arm group label: Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)
  arm group type: Experimental
  description: Cycle 1 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  Day 8: rituximab
  Day 15: rituximab
  Cycle 2 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).
  arm group label: Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)
  arm group type: Experimental
  description: Cycle 1 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  Day 8: rituximab
  Day 15: rituximab
  Cycle 2 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))
  arm group type: Experimental
  description: Cycle 1 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  Day 8: rituximab
  Day 15: rituximab
  Cycle 2 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)
  arm group type: Experimental
  description: Cycle 1 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  Day 8: rituximab
  Day 15: rituximab
  Cycle 2 (21 days)
  Day 1: polatuzumab vedotin + rituximab
  After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).
  intervention type: Drug
  intervention name: Polatuzumab vedotin
  description: Given at 1.8 mg/kg
  arm group label: Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))
  other name: Polivy
  intervention type: Drug
  intervention name: Rituximab
  description: Given at 375 mg/m^2
  arm group label: Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))
  other name: Rituxan
  intervention type: Drug
  intervention name: CHP
  description: Cyclophosphamide (750 mg/m^2) + doxorubicin (50 mg/m^2) + prednisone (100 mg days 2-6)
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)
  arm group label: Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neha Mehta-Shah, M.D.
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Neha Mehta-Shah, M.D.
  phone: 314-747-7510
  email: mehta-n@wustl.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  url: http://www.siteman.wustl.edu
  description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  responsible party type: Sponsor
  mesh term: Lymphoproliferative Disorders
  mesh term: Rituximab
  mesh term: Polatuzumab vedotin
  sharing ipd: No