Status:
ACTIVE_NOT_RECRUITING
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Lead Sponsor:
BeiGene
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 lymphocy...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT03336333
Start Date
October 31 2017
End Date
September 1 2026
Last Update
March 7 2025
Active Locations (158)
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1
Augusta University
Augusta, Georgia, United States, 30912
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Research Medical Center
Kansas City, Missouri, United States, 64132