<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/NCT02992522</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-16187</org_study_id>
    <secondary_id>NCI-2016-01723</secondary_id>
    <nct_id>NCT02992522</nct_id>
  </id_info>
  <brief_title>Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma</brief_title>
  <official_title>A Phase I Study of Obinutuzumab, Venetoclax, and Lenalidomide in Relapsed and Refractory B-cell Non-Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Christian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I study studies the side effects and best dose of venetoclax and lenalidomide when&#xD;
      given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that&#xD;
      has returned after a period of improvement or not responding to treatment. Monoclonal&#xD;
      antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and&#xD;
      spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed&#xD;
      for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to&#xD;
      stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,&#xD;
      or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may&#xD;
      work better in treating patients with B-cell non-Hodgkin lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the dose limiting toxicity (DLT) and the recommended phase 2 dose (RP2D),&#xD;
      which is typically the maximum tolerated dose (MTD), of the combination of obinutuzumab,&#xD;
      venetoclax, and lenalidomide in patients with relapsed or refractory B-cell non-Hodgkin&#xD;
      lymphoma (NHL).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the overall objective response rate to the combination of obinutuzumab,&#xD;
      venetoclax, and lenalidomide in patients with relapsed or refractory B-cell NHL.&#xD;
&#xD;
      II. To estimate the duration of response and 2 year progression-free survival associated with&#xD;
      obinutuzumab, venetoclax, and lenalidomide treatment in patients with relapsed and refractory&#xD;
      B-cell NHL.&#xD;
&#xD;
      III. To define the qualitative and quantitative toxicities of the combination of&#xD;
      obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell&#xD;
      NHL.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of venetoclax and lenalidomide.&#xD;
&#xD;
      Patients receive lenalidomide orally (PO) on days 1-21 and venetoclax PO on days 1-28.&#xD;
      Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of course 1 and on&#xD;
      day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of&#xD;
      disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4 weeks, every 3 months for&#xD;
      2 years, then every 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</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>MTD defined as the highest level at which no more than 6 patients experience a DLT assessed by National Cancer Institute Common Terminology Criteria of Adverse Events version 4</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>The recommended phase 2 dose (RP2D), which is typically the maximum tolerated dose (MTD), of the combination of obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR) defined as the proportion of patients achieving a complete or partial, response according to the Lugano Lymphoma Response Criteria</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>ORR will be reported with a 95% binomial confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From course 1 day 1 to the date of the event (i.e., death or disease progression), assessed up to 2 years</time_frame>
    <description>PFS will be estimated using the method of Kaplan-Meier. Median PFS and 2-year PFS estimates will be reported with 95% confidence intervals. If applicable, a sensitivity analysis of PFS will include any eligible patient who receives at least one dose of study treatment (i.e. venetoclax alone without beginning the combination regimen).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>B-Cell Lymphoma, Unspecified</condition>
  <condition>Grade 1 Follicular Lymphoma</condition>
  <condition>Grade 2 Follicular Lymphoma</condition>
  <condition>Grade 3a Follicular Lymphoma</condition>
  <condition>Recurrent Burkitt Lymphoma</condition>
  <condition>Recurrent Diffuse Large B-Cell Lymphoma</condition>
  <condition>Recurrent Follicular Lymphoma</condition>
  <condition>Recurrent Marginal Zone Lymphoma</condition>
  <condition>Refractory Burkitt Lymphoma</condition>
  <condition>Refractory Diffuse Large B-Cell Lymphoma</condition>
  <condition>Refractory Follicular Lymphoma</condition>
  <condition>Transformed Recurrent Non-Hodgkin Lymphoma</condition>
  <condition>B-Cell</condition>
  <arm_group>
    <arm_group_label>Treatment (lenalidomide, venetoclax, obinutuzumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive lenalidomide PO on days 1-21 and venetoclax PO on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of course 1, and day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (lenalidomide, venetoclax, obinutuzumab)</arm_group_label>
    <other_name>CC-5013</other_name>
    <other_name>CC5013</other_name>
    <other_name>CDC 501</other_name>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (lenalidomide, venetoclax, obinutuzumab)</arm_group_label>
    <other_name>Anti-CD20 Monoclonal Antibody R7159</other_name>
    <other_name>GA-101</other_name>
    <other_name>GA101</other_name>
    <other_name>Gazyva</other_name>
    <other_name>huMAB(CD20)</other_name>
    <other_name>R7159</other_name>
    <other_name>RO 5072759</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (lenalidomide, venetoclax, obinutuzumab)</arm_group_label>
    <other_name>ABT-0199</other_name>
    <other_name>ABT-199</other_name>
    <other_name>ABT199</other_name>
    <other_name>GDC-0199</other_name>
    <other_name>RG7601</other_name>
    <other_name>Venclexta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Prior venetoclax or other BCL-2 family inhibitors or prior lenalidomide is not&#xD;
             permitted&#xD;
&#xD;
          -  Creatinine clearance &gt;= 50 ml/min using a 24 hour creatinine clearance or estimated&#xD;
             creatinine clearance using the Cockcroft-Gault equation&#xD;
&#xD;
          -  Bilirubin =&lt; 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome&#xD;
&#xD;
          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =&lt; 3 x ULN&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1000/mm^3&#xD;
&#xD;
          -  Platelet &gt;= 75,000/mm^3&#xD;
&#xD;
               -  Unless related to bone marrow involvement with disease, in which case platelets&#xD;
                  must be &gt;= 50,000/mm^3&#xD;
&#xD;
          -  Recovery to =&lt; grade 1 from all toxicities associated with prior therapy except&#xD;
             alopecia&#xD;
&#xD;
          -  Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of any of the following&#xD;
             subtypes recognized by the World Health Organization (WHO) classification: Burkitt&#xD;
             lymphoma, B-cell lymphoma unclassifiable with features intermediate between diffuse&#xD;
             large B-cell lymphoma and Burkitt lymphoma, diffuse large B-cell lymphoma, marginal&#xD;
             zone lymphoma, or follicular lymphoma; patients with evidence of histological&#xD;
             transformation to diffuse large B-cell lymphoma from indolent NHL are eligible&#xD;
&#xD;
          -  At least one prior therapy; prior autologous stem cell transplant is permitted;&#xD;
             patients with aggressive lymphoma who have not received high-dose therapy&#xD;
             (HDT)/autologous stem cell transplantation (ASCT) must be ineligible for HDT/ASCT;&#xD;
             prior allogeneic stem cell transplant is not permitted&#xD;
&#xD;
          -  Patients with indolent lymphoma must have an indication for treatment in the opinion&#xD;
             of the investigator&#xD;
&#xD;
          -  Radiographically measurable disease by computed tomography (CT) scan, defined as at&#xD;
             least one node &gt; 1.5 cm in size or assessable disease&#xD;
&#xD;
          -  All study participants must be registered into the mandatory Revlimid risk evaluation&#xD;
             and mitigation strategy (REMS) program, and be willing and able to comply with the&#xD;
             requirements of the REMS program&#xD;
&#xD;
          -  Females of reproductive potential must adhere to the scheduled pregnancy testing as&#xD;
             required in the Revlimid REMS program&#xD;
&#xD;
          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients&#xD;
             intolerant to aspirin (ASA) may use low molecular weight heparin or equivalent)&#xD;
&#xD;
          -  EXPANSION COHORT&#xD;
&#xD;
          -  Cohort A will enroll 10 patients with a diagnosis of diffuse large B-cell lymphoma;&#xD;
             B-cell lymphoma unclassifiable with features intermediate between diffuse large B-cell&#xD;
             lymphoma and Burkitt lymphoma (double hit lymphoma), Burkitt lymphoma, and transformed&#xD;
             lymphoma&#xD;
&#xD;
          -  Cohort B will enroll 20 patients with a diagnosis of follicular lymphoma, grade 1-2&#xD;
             and 3A; grade 3B is excluded; diagnoses made by a fine needle aspirate or bone marrow&#xD;
             biopsy alone are not permitted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active central nervous system (CNS) involvement with lymphoma are not&#xD;
             eligible&#xD;
&#xD;
          -  Patients with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1&#xD;
             (HTLV-1) are not eligible&#xD;
&#xD;
          -  Evidence of active hepatitis B infection, based on positive surface antigen or&#xD;
             hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), or active&#xD;
             hepatitis C infection; patients who are hepatitis B core antibody positive must take&#xD;
             prophylaxis with lamivudine or equivalent and be willing to undergo monthly hepatitis&#xD;
             B DNA PCR testing&#xD;
&#xD;
          -  Prior allogeneic stem cell transplant is not permitted&#xD;
&#xD;
          -  Unable to swallow capsules or malabsorption syndrome, disease significantly affecting&#xD;
             gastrointestinal function, or resection of the stomach or small bowel or ulcerative&#xD;
             colitis, symptomatic inflammatory bowel disease, or partial or complete bowel&#xD;
             obstruction likely to interfere with the delivery, absorption, or metabolism of&#xD;
             venetoclax or lenalidomide&#xD;
&#xD;
          -  Any chemotherapy or radiation therapy within 4 weeks of the first dose of study drug&#xD;
&#xD;
          -  Patients may take steroids for disease control up to 24 hours prior to study&#xD;
             enrollment&#xD;
&#xD;
          -  Any illness, medical condition or organ system dysfunction which, in the&#xD;
             investigator's opinion, could compromise the subject's safety, interfere with the&#xD;
             absorption or metabolism of venetoclax and lenalidomide, or put the study outcomes at&#xD;
             undue risk&#xD;
&#xD;
          -  A cardiovascular disability status of New York Heart Association class &gt;= 2&#xD;
&#xD;
          -  History of severe allergic reactions to humanized monoclonal antibodies&#xD;
&#xD;
          -  History of other malignancy that could affect compliance with the protocol or&#xD;
             interpretation of results; patients with a history of curatively treated basal or&#xD;
             squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the&#xD;
             cervix are eligible; patients with a malignancy that has been treated with surgery&#xD;
             alone with curative intent will also be excluded; individuals in documented remission&#xD;
             without treatment for &gt;= 2 years prior to enrollment may be included at the discretion&#xD;
             of the investigator&#xD;
&#xD;
          -  Known hypersensitivity to any of the study drugs or analogs&#xD;
&#xD;
          -  Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection&#xD;
             (excluding fungal infections of nail beds) at study enrollment, or any major episode&#xD;
             of infection requiring treatment with IV antibiotics or hospitalization (relating to&#xD;
             the completion of the course of antibiotics) within 4 weeks prior study therapy&#xD;
&#xD;
          -  Requires the use of warfarin (because of potential drug-drug interactions that may&#xD;
             potentially increase the exposure of warfarin)&#xD;
&#xD;
          -  Received the following agents within 7 days prior to the first dose of venetoclax:&#xD;
&#xD;
               -  Strong and moderate CYP3A inhibitors&#xD;
&#xD;
               -  Strong and moderate CYP3A inducers&#xD;
&#xD;
               -  Consumed grapefruit, grapefruit products, Seville oranges (including marmalade&#xD;
                  containing Seville oranges), or star fruit within 3 days prior to the first dose&#xD;
                  of venetoclax&#xD;
&#xD;
          -  Clinically significant history of liver disease, including viral or other hepatitis,&#xD;
             current alcohol abuse, or cirrhosis&#xD;
&#xD;
          -  Receipt of live-virus vaccines within 28 days prior to the initiation of study&#xD;
             treatment or need for live-virus vaccines at any time during study treatment&#xD;
&#xD;
          -  Recent major surgery (within 6 weeks prior to the start of study treatment) other than&#xD;
             for diagnosis&#xD;
&#xD;
          -  Malabsorption syndrome or other condition that precludes enteral route of&#xD;
             administration&#xD;
&#xD;
          -  Known allergy to both xanthine oxidase inhibitors and rasburicase&#xD;
&#xD;
          -  Pregnant or lactating, or intending to become pregnant during the study&#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>Beth Christian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Beth Christian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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, Follicular</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Obinutuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02992522
org study id: OSU-16187
secondary id: NCI-2016-01723
nct id: NCT02992522
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase I study studies the side effects and best dose of venetoclax and lenalidomide when
      given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that
      has returned after a period of improvement or not responding to treatment. Monoclonal
      antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and
      spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed
      for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to
      stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,
      or by stopping them from spreading. Giving obinutuzumab, venetoclax, and lenalidomide may
      work better in treating patients with B-cell non-Hodgkin lymphoma.
PRIMARY OBJECTIVES:

      I. To determine the dose limiting toxicity (DLT) and the recommended phase 2 dose (RP2D),
      which is typically the maximum tolerated dose (MTD), of the combination of obinutuzumab,
      venetoclax, and lenalidomide in patients with relapsed or refractory B-cell non-Hodgkin
      lymphoma (NHL).

      SECONDARY OBJECTIVES:

      I. To estimate the overall objective response rate to the combination of obinutuzumab,
      venetoclax, and lenalidomide in patients with relapsed or refractory B-cell NHL.

      II. To estimate the duration of response and 2 year progression-free survival associated with
      obinutuzumab, venetoclax, and lenalidomide treatment in patients with relapsed and refractory
      B-cell NHL.

      III. To define the qualitative and quantitative toxicities of the combination of
      obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell
      NHL.

      OUTLINE: This is a dose-escalation study of venetoclax and lenalidomide.

      Patients receive lenalidomide orally (PO) on days 1-21 and venetoclax PO on days 1-28.
      Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of course 1 and on
      day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 4 weeks, every 3 months for
      2 years, then every 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MTD defined as the highest level at which no more than 6 patients experience a DLT assessed by National Cancer Institute Common Terminology Criteria of Adverse Events version 4
time frame: Up to 28 days
description: The recommended phase 2 dose (RP2D), which is typically the maximum tolerated dose (MTD), of the combination of obinutuzumab, venetoclax, and lenalidomide in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
measure: Objective response rate (ORR) defined as the proportion of patients achieving a complete or partial, response according to the Lugano Lymphoma Response Criteria
time frame: Up to 3 years
description: ORR will be reported with a 95% binomial confidence interval.
measure: Progression-free survival
time frame: From course 1 day 1 to the date of the event (i.e., death or disease progression), assessed up to 2 years
description: PFS will be estimated using the method of Kaplan-Meier. Median PFS and 2-year PFS estimates will be reported with 95% confidence intervals. If applicable, a sensitivity analysis of PFS will include any eligible patient who receives at least one dose of study treatment (i.e. venetoclax alone without beginning the combination regimen).
arm group label: Treatment (lenalidomide, venetoclax, obinutuzumab)
arm group type: Experimental
description: Patients receive lenalidomide PO on days 1-21 and venetoclax PO on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of course 1, and day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Lenalidomide
description: Given PO
arm group label: Treatment (lenalidomide, venetoclax, obinutuzumab)
other name: CC-5013
other name: CC5013
other name: CDC 501
other name: Revlimid
intervention type: Biological
intervention name: Obinutuzumab
description: Given IV
arm group label: Treatment (lenalidomide, venetoclax, obinutuzumab)
other name: Anti-CD20 Monoclonal Antibody R7159
other name: GA-101
other name: GA101
other name: Gazyva
other name: huMAB(CD20)
other name: R7159
other name: RO 5072759
intervention type: Drug
intervention name: Venetoclax
description: Given PO
arm group label: Treatment (lenalidomide, venetoclax, obinutuzumab)
other name: ABT-0199
other name: ABT-199
other name: ABT199
other name: GDC-0199
other name: RG7601
other name: Venclexta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Beth Christian, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Beth Christian
investigator title: Principal Investigator
mesh term: Burkitt Lymphoma
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Recurrence
mesh term: Lenalidomide
mesh term: Venetoclax
mesh term: Obinutuzumab
sharing ipd: No