A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Key Inclusion Criteria

Confirmed diagnosis of CLL or SLL that meets the 2008 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 CT/magnetic resonance imaging (MRI)
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 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.