Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

• Status: Active, not recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborators: AbbVie; German CLL Study Group
• Treatments: Chlorambucil; Obinutuzumab; Venetoclax

Criteria

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