A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
About the study
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria
- Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
- CLL/SLL requiring treatment per 2008 IWCLL criteria
- Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
- Measurable disease by Computerized Tomography (CT)/magnetic resonance imaging (MRI)
- 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
EXCLUSION CRITERIA
Key Exclusion Criteria
- Known prolymphocytic leukemia or history of, or currently 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 or breast
- History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
- Severe or debilitating pulmonary disease
- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- Known central nervous system involvement by leukemia or lymphoma
- Known infection with HIV or active viral hepatitis B or C infection
- Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
- Major surgery within 4 weeks of the first dose of study drug
- Prior treatment with a (Burton's Kinase) BTK inhibitor
- Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
- Pregnant or lactating women
- Vaccination with a live vaccine within 35 days prior to the first dose of study drug
- Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
- Concurrent participation in another therapeutic clinical trial
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Chronic Lymphocytic Leukemia,Small Lymphocytic Lymphoma
Age (in years)
18+
Phase
Phase 3
Participants needed
652
Est. Completion Date
Apr 30, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT03734016
Study number
BGB-3111-305
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