Status:
COMPLETED
Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
AbbVie
German CLL Study Group
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT02242942
Start Date
December 31 2014
End Date
August 27 2025
Last Update
November 6 2025
Active Locations (122)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
City of Hope
Duarte, California, United States, 91010
3
UC San Diego Health System
La Jolla, California, United States, 92093
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497