Chronic Lymphocytic Leukemia Clinical Trial
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory leukemia-cll/" >chronic lymphocytic leukemia or small lymphocytic lymphoma.
This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in 652 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants were randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib was open label.
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
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.
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There are 9 Locations for this study
Bialystok , 15748, Poland
Brzozow , 36-20, Poland
Chorzow , 41-50, Poland
Gdansk , 80-95, Poland
Gdask , 80-21, Poland
Krakow , 30-51, Poland
Legnica , 59-22, Poland
Lodz , 93-51, Poland
Poznan , 60-56, Poland
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