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A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Trial Status: closed to accrual
To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients
with previously untreated CLL/SLL, as measured by progression free survival assess by
Independent Central Review.
Inclusion Criteria
Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
Measurable disease by imaging
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Life expectancy ≥ 6 months
Adequate bone marrow function
Adequate renal and hepatic function Key
Exclusion Criteria
Previous systemic treatment for CLL/SLL
Requires ongoing need for corticosteroid treatment
Known prolymphocytic leukemia or history of or suspected Richter's transformation.
Clinically significant cardiovascular disease
Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer
History of severe bleeding disorder
History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug
Severe or debilitating pulmonary disease
Inability to swallow capsules or disease affecting gastrointestinal function
Active infection requiring systemic treatment
Known central nervous system involvement by leukemia or lymphoma
Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs
Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection
Major surgery ≤ 4 weeks prior to start of study treatment
Pregnant or nursing females
Vaccination with live vaccine within 35 days prior to the first dose of study drug.
Ongoing alcohol or drug addiction
Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs
Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer
Concurrent participation in another therapeutic clinical study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT03336333.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not Available
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
This is a global phase 3, open label, randomized study of zanubrutinib versus
bendamustine plus rituximab (B+R) in participants with previously untreated chronic
lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including participants
without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3].
Participants in Cohort 1 are randomized 1:1 to zanubrutinib (Arm A) or bendamustine plus
rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin
variable region heavy chain (IGHV) mutational status, and geographic region. Participants
in Cohort 2 will receive treatment with zanubrutinib. Participants in Cohort 3 will
receive treatment with zanubrutinib and venetoclax.
