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A Study of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine And MabThera/Rituxan in Participants With Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Genentech, Inc.
Sponsor:
Collaborator:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01671904
First received: August 10, 2012
Last updated: August 1, 2016
Last verified: August 2016

August 10, 2012
August 1, 2016
January 2014
November 2016   (final data collection date for primary outcome measure)
  • Maximum Tolerated Dose [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Maximum Tolerated Dose [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01671904 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Complete Response [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Changes in B-cells [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Changes in T-cells [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Changes in Natural Killer (NK) Cells [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Changes in Serum Immunoglobulin [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximal Plasma Concentration (Cmax) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Minimum Plasma Concentration (Cmin) [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration Time Curve [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
Pharmacokinetics: Area Under the Concentration Time Curve [ Time Frame: Pre-dose and up to 24 h post-dose of each dosing day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine And MabThera/Rituxan in Participants With Chronic Lymphocytic Leukemia
A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia
This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of Venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and MabThera/Rituxan (rituximab) or bendamustine and obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphocytic Leukemia, Chronic
  • Drug: Bendamustine
    90 mg/m^2 of bendamustine administered by intravenous infusion on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
  • Drug: Bendamustine
    70 mg/m^2 of bendamustine administered by intravenous infusion on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
  • Drug: Obinutuzumab
    100 mg of obinutuzumab administered by intravenous infusion on Day 1 of Cycle 1; 900 mg administered on Day 2 of Cycle 1; and 1000 mg administered on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
    Other Name: GA101; RO5072759
  • Drug: Rituximab
    375 mg/m^2 of rituximab administered by intravenous infusion on Day 1 of Cycle 1 and 500 mg/m^2 administered on Day 1 of Cycles 2-6.
    Other Name: MabThera; Rituxan
  • Drug: Venetoclax (ABT-199; GDC-0199)
    Multiple doses of venetoclax administered orally once daily.
    Other Name: ABT-199; GDC-0199
  • Experimental: Label: 1 Dose-Finding: Schedule A: Relapsed/Refractory CLL
    In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax (GDC-0199; ABT-199) will be administered in combination with fixed dose bendamustine and rituximab in the dose-finding stage. In Schedule A venetoclax (GDC-0199; ABT-199) will be introduced before bendamustine and rituximab. Schedule A will be explored prior to Schedule B.
    Interventions:
    • Drug: Bendamustine
    • Drug: Bendamustine
    • Drug: Rituximab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 2 Dose-Finding: Schedule B: Relapsed/Refractory CLL
    In 4 cohorts of participants with relapsed/refractory CLL escalating doses of venetoclax (GDC-0199; ABT-199) will be administered in combination with fixed dose bendamustine and rituximab in the dose-finding stage. In Schedule B venetoclax (GDC-0199; ABT-199) will be introduced after bendamustine and rituximab. Schedule A will be explored prior to Schedule B.
    Interventions:
    • Drug: Bendamustine
    • Drug: Rituximab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 3 Dose-Finding: Schedule A: Previously Untreated CLL
    In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax (GDC-0199; ABT-199) will be administered in combination with fixed dose bendamustine and rituximab in the dose-finding stage. In Schedule A venetoclax (GDC-0199; ABT-199) will be introduced before bendamustine and rituximab. Schedule A will be explored prior to Schedule B.
    Interventions:
    • Drug: Bendamustine
    • Drug: Rituximab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 4 Dose-Finding: Schedule B: Previously Untreated CLL
    In 4 cohorts of participants with previously untreated CLL escalating doses of venetoclax (GDC-0199; ABT-199) will be administered in combination with fixed dose bendamustine and rituximab in the dose-finding stage. In Schedule B venetoclax (GDC-0199; ABT-199) will be introduced after bendamustine and rituximab . Schedule A will be explored prior to Schedule B.
    Interventions:
    • Drug: Bendamustine
    • Drug: Rituximab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 5 Dose-Finding: Schedule A (Optional): CLL
    Optional study arm: In 4 cohorts of participants with relapsed/refractory or previously untreated CLL escalating doses of venetoclax (GDC-0199; ABT-199) will be administered in combination with fixed dose bendamustine and obinutuzumab in the dose-finding stage. In Schedule A venetoclax (GDC-0199; ABT-199) will be introduced before bendamustine and obinutuzumab. Schedule A will be explored prior to Schedule B.
    Interventions:
    • Drug: Bendamustine
    • Drug: Obinutuzumab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 6 Safety Expansion: Relapsed/Refractory CLL
    In participants with relapsed/refractory CLL a recommended dose of venetoclax (GDC-0199; ABT-199) will be administered in combination with bendamustine and rituximab in the safety expansion stage.In participants with relapsed/refractory CLL a recommended dose of venetoclax (GDC-0199; ABT-199) will be administered in combination with bendamustine and rituximab in the safety expansion stage.
    Interventions:
    • Drug: Bendamustine
    • Drug: Rituximab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 7 Safety Expansion: Previously Untreated CLL
    In participants with previously untreated CLL a recommended dose of venetoclax (GDC-0199; ABT-199) will be administered in combination with bendamustine and rituximab in the safety expansion stage.
    Interventions:
    • Drug: Bendamustine
    • Drug: Rituximab
    • Drug: Venetoclax (ABT-199; GDC-0199)
  • Experimental: Label: 8 Safety Expansion (Optional): Previously Untreated CLL
    In participants with previously untreated CLL a recommended dose of venetoclax (GDC-0199; ABT-199) will be administered in combination with bendamustine and obinutuzumab in the safety expansion stage.
    Interventions:
    • Drug: Bendamustine
    • Drug: Obinutuzumab
    • Drug: Venetoclax (ABT-199; GDC-0199)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2019
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
  • Eastern Cooperative Oncology Group (ECOG) performance score of </=1
  • Adequate bone marrow function
  • Adequate renal and hepatic function

Exclusion Criteria:

  • Participants received an allogeneic stem cell transplant
  • Infection with human immunodeficiency virus, hepatitis B (eligible only if polymerase chain reaction [PCR] is negative for hepatitis B), or hepatitis C (eligible only if PCR is negative for hepatitis C ribonucleic acid)
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Investigational or anti-cancer therapy within 14 days of study start (30 days for biologic agents for anti-neoplastic intent)
  • History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
Both
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: GO28440 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com
United States,   France,   Germany
 
NCT01671904
GO28440, 2012-002351-42
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
AbbVie (prior sponsor, Abbott)
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP