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

Completed · Phase 3

Conditions studied: Lymphocytic Leukemia, Chronic

In brief

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

Key facts

Study ID

NCT02242942

Run by

Hoffmann-La Roche

People needed

445

Starts

2014-12-31

Expected to finish

2025-08-27

Last updated by the study team

2025-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States
• UC San Diego Health System — La Jolla, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Joe Arrington Cancer Center — Lubbock, Texas, United States
• Hospital Italiano — Buenos Aires, Argentina
• Liverpool Hospital — Liverpool BC, New South Wales, Australia
• Tweed Hospital — Tweed Heads, New South Wales, Australia
• The Townsville Hospital — Douglas, Queensland, Australia
• Princess Alexandra Hospital Woolloongabba — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Ashford Cancer Centre Research — Ashford, South Australia, Australia
• Box Hill Hospital — Box Hill, Victoria, Australia
• The Northern Hospital — Epping, Victoria, Australia
• Monash Medical Centre — Melbourne, Victoria, Australia
• Tiroler Landeskrankenanstalten Ges.M.B.H. — Innsbruck, Austria
• Medizinische Universität Wien — Vienna, Austria
• Hanusch-Krankenhaus — Vienna, Austria
• Hospital das Clinicas - UFRGS — Porto Alegre, Rio Grande do Sul, Brazil
• Instituto de Ensino e Pesquisa Sao Lucas - IEP — São Paulo, São Paulo, Brazil
• Hospital Sírio-Libanês — São Paulo, São Paulo, Brazil
• Hospital das Clinicas - FMUSP — São Paulo, São Paulo, Brazil
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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