<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/NCT01685892</url>
  </required_header>
  <id_info>
    <org_study_id>GP28331</org_study_id>
    <secondary_id>2012-002038-34</secondary_id>
    <nct_id>NCT01685892</nct_id>
    <nct_alias>NCT02339181</nct_alias>
  </id_info>
  <brief_title>A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia</brief_title>
  <official_title>A Phase Ib Multicenter Dose-Finding and Safety Study of Venetoclax and Obinutuzumab in Patients With Relapsed or Refractory or Previously Untreated Chronic Lymphocytic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Genentech, Inc.</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 multi-center, open-label, dose-finding study will evaluate the safety and&#xD;
      pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199)&#xD;
      administered in combination with obinutuzumab to participants with relapsed/refractory or&#xD;
      previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages&#xD;
      for each participant population: a dose-finding stage and a safety-expansion stage. The&#xD;
      dose-finding stage will explore multiple doses of venetoclax to be used in combination with a&#xD;
      fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug&#xD;
      administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B&#xD;
      (venetoclax introduced after obinutuzumab).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2012</start_date>
  <completion_date type="Actual">August 23, 2019</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <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>Percentage of Participants With Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Schedule (Sch) A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD) of Venetoclax in Combination with Obinutuzumab</measure>
    <time_frame>Sch A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Obinutuzumab</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve (AUC) of Venetoclax</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal Plasma Concentration (Cmax) of Venetoclax</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Plasma Concentration (Cmin) of Venetoclax</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of Obinutuzumab</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Obinutuzumab</measure>
    <time_frame>Baseline up to Cycle 6 (1 Cycle=28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Confirmed Complete Response (CR) as Determined by Standard CLL Response Criteria</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Objective Response (Partial Response [PR] or CR [Including Cytopenic CR] as Determined by Standard CLL Response Criteria</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response as Determined by Standard CLL Response Criteria</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Baseline up to death or end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival as Determined by Standard CLL Response Criteria</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Number of B-Cells</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Number of T-Cells</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Number of Natural Killer (NK) Cells</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Serum Immunoglobulin Level</measure>
    <time_frame>Baseline up to end of study (up to approximately 5 years and 5 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Lymphocytic Leukemia, Chronic</condition>
  <arm_group>
    <arm_group_label>Dose-Finding: Schedule A: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose-Finding: Schedule B: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose-Finding: Schedule A: Previously Untreated CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose-Finding: Schedule B: Previously Untreated CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety Expansion: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with relapsed/refractory CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety Expansion: Previously Untreated CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants with previously untreated CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>Participants will receive IV infusion of obinutuzumab 100 milligrams (mg) on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.</description>
    <arm_group_label>Dose-Finding: Schedule A: Previously Untreated CLL</arm_group_label>
    <arm_group_label>Dose-Finding: Schedule A: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_label>Dose-Finding: Schedule B: Previously Untreated CLL</arm_group_label>
    <arm_group_label>Dose-Finding: Schedule B: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_label>Safety Expansion: Previously Untreated CLL</arm_group_label>
    <arm_group_label>Safety Expansion: Relapsed/Refractory CLL</arm_group_label>
    <other_name>GA101; RO5072759</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Participants will receive multiple doses of venetoclax orally once daily.</description>
    <arm_group_label>Dose-Finding: Schedule A: Previously Untreated CLL</arm_group_label>
    <arm_group_label>Dose-Finding: Schedule A: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_label>Dose-Finding: Schedule B: Previously Untreated CLL</arm_group_label>
    <arm_group_label>Dose-Finding: Schedule B: Relapsed/Refractory CLL</arm_group_label>
    <arm_group_label>Safety Expansion: Previously Untreated CLL</arm_group_label>
    <arm_group_label>Safety Expansion: Relapsed/Refractory CLL</arm_group_label>
    <other_name>ABT-199, GDC-0199</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to&#xD;
             (&lt;/=) 1&#xD;
&#xD;
          -  Adequate bone marrow function&#xD;
&#xD;
          -  Adequate coagulation, renal and hepatic function&#xD;
&#xD;
          -  For all participants, agreement to remain abstinent or use contraceptive methods that&#xD;
             result in a failure rate of less than (&lt;) 1% per year during the treatment period and&#xD;
             for at least 90 days (30 days for women) after the last dose of venetoclax or 18&#xD;
             months after the last dose of obinutuzumab, whichever is longer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have undergone allogenic stem cell transplant are ineligible unless&#xD;
             they meet the following criteria, a) participants who are off all immunosuppressive&#xD;
             therapy, b) participants who have no signs and/or symptoms of acute or chronic graft&#xD;
             versus host disease, or c) participants must have appropriate hematology counts&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C&#xD;
&#xD;
          -  Uncontrolled autoimmune hemolytic anemia or thrombocytopenia&#xD;
&#xD;
          -  Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of&#xD;
             study drug&#xD;
&#xD;
          -  History of significant renal, neurologic, psychiatric, endocrinologic, metabolic,&#xD;
             immunologic, cardiovascular, or hepatic disease&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College-New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</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>
    <facility>
      <name>Oncology Associates of Oregon</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI-Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital Research Institute; Academic Office of Clinical Trials</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary NHS Trust</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts and The London School of Medicine and Dentistry; Queen Mary, University of London</name>
      <address>
        <city>London</city>
        <zip>E1 2AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</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>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Obinutuzumab</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/NCT01685892
org study id: GP28331
secondary id: 2012-002038-34
nct id: NCT01685892
nct alias: NCT02339181
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This multi-center, open-label, dose-finding study will evaluate the safety and
      pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199)
      administered in combination with obinutuzumab to participants with relapsed/refractory or
      previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages
      for each participant population: a dose-finding stage and a safety-expansion stage. The
      dose-finding stage will explore multiple doses of venetoclax to be used in combination with a
      fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug
      administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B
      (venetoclax introduced after obinutuzumab).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Dose Limiting Toxicities (DLTs)
time frame: Schedule (Sch) A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)
measure: Maximum Tolerated Dose (MTD) of Venetoclax in Combination with Obinutuzumab
time frame: Sch A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)
measure: Percentage of Participants with Adverse Events
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Obinutuzumab
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Area Under the Concentration-Time Curve (AUC) of Venetoclax
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Maximal Plasma Concentration (Cmax) of Venetoclax
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Minimum Plasma Concentration (Cmin) of Venetoclax
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Cmax of Obinutuzumab
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Cmin of Obinutuzumab
time frame: Baseline up to Cycle 6 (1 Cycle=28 days)
measure: Percentage of Participants with Confirmed Complete Response (CR) as Determined by Standard CLL Response Criteria
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Percentage of Participants with Objective Response (Partial Response [PR] or CR [Including Cytopenic CR] as Determined by Standard CLL Response Criteria
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Duration of Objective Response as Determined by Standard CLL Response Criteria
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Overall Survival
time frame: Baseline up to death or end of study (up to approximately 5 years and 5 months)
measure: Progression-Free Survival as Determined by Standard CLL Response Criteria
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Change from Baseline in Number of B-Cells
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Change from Baseline in Number of T-Cells
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Change from Baseline in Number of Natural Killer (NK) Cells
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
measure: Change from Baseline in Serum Immunoglobulin Level
time frame: Baseline up to end of study (up to approximately 5 years and 5 months)
arm group label: Dose-Finding: Schedule A: Relapsed/Refractory CLL
arm group type: Experimental
description: All 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B.
arm group label: Dose-Finding: Schedule B: Relapsed/Refractory CLL
arm group type: Experimental
description: In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B.
arm group label: Dose-Finding: Schedule A: Previously Untreated CLL
arm group type: Experimental
description: All 4 cohorts will begin venetoclax administration after the ramp-up period of 5 weeks. In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule A, venetoclax will be introduced before obinutuzumab. Schedule A will be explored prior to Schedule B.
arm group label: Dose-Finding: Schedule B: Previously Untreated CLL
arm group type: Experimental
description: In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax will be administered in combination with fixed dose obinutuzumab in the dose-finding stage. In Schedule B, venetoclax will be introduced after obinutuzumab. Schedule A will be explored prior to Schedule B.
arm group label: Safety Expansion: Relapsed/Refractory CLL
arm group type: Experimental
description: In participants with relapsed/refractory CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage.
arm group label: Safety Expansion: Previously Untreated CLL
arm group type: Experimental
description: In participants with previously untreated CLL a recommended dose of venetoclax will be administered in combination with obinutuzumab in the safety expansion stage. Schedule A or B will be used for the expansion cohort after a review of available safety data from the dose finding stage.
intervention type: Drug
intervention name: Obinutuzumab
description: Participants will receive IV infusion of obinutuzumab 100 milligrams (mg) on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
arm group label: Dose-Finding: Schedule A: Previously Untreated CLL
arm group label: Dose-Finding: Schedule A: Relapsed/Refractory CLL
arm group label: Dose-Finding: Schedule B: Previously Untreated CLL
arm group label: Dose-Finding: Schedule B: Relapsed/Refractory CLL
arm group label: Safety Expansion: Previously Untreated CLL
arm group label: Safety Expansion: Relapsed/Refractory CLL
other name: GA101; RO5072759
intervention type: Drug
intervention name: Venetoclax
description: Participants will receive multiple doses of venetoclax orally once daily.
arm group label: Dose-Finding: Schedule A: Previously Untreated CLL
arm group label: Dose-Finding: Schedule A: Relapsed/Refractory CLL
arm group label: Dose-Finding: Schedule B: Previously Untreated CLL
arm group label: Dose-Finding: Schedule B: Relapsed/Refractory CLL
arm group label: Safety Expansion: Previously Untreated CLL
arm group label: Safety Expansion: Relapsed/Refractory CLL
other name: ABT-199, GDC-0199
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Venetoclax
mesh term: Obinutuzumab