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A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia
- Leukemia
Trial Status:
Active, not recruiting
This trial runs in
Countries
- Argentina
- Australia
- Austria
- Brazil
- Bulgaria
- Canada
- Croatia
- Denmark
- Estonia
- France
- Germany
- Italy
- Mexico
- New Zealand
- Poland
- Romania
- Russia
- Spain
- Switzerland
- United Kingdom
- United States
Trial Identifier:
NCT02242942 2014-001810-24, CLL14 BO25323
Trial Summary
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02242942 , BO25323 , 2014-001810-24, CLL14
Trial Identifier
Chlorambucil, Venetoclax, Obinutuzumab
Treatments
Lymphocytic Leukemia, Chronic
Condition
Official Title
A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
- CLL requiring treatment according to IWCLL criteria
- Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
- Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
- Adequate liver function
- Life expectancy > 6 months
- Agreement to use highly effective contraceptive methods per protocol
Exclusion Criteria
- Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
- Known central nervous system involvement
- Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
- An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
- Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Inadequate renal function
- History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
- Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
- Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
- Pregnant women and nursing mothers
- Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
- Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
- Requires the use of warfarin, marcumar, or phenprocoumon
- Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug
For the latest version of this information please go to www.forpatients.roche.com