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

Korábbi kezelés

• History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
• 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
• Vaccination with a live vaccine within 35 days prior to the first dose of study drug
• Concurrent participation in another therapeutic clinical trial
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Más betegség

• 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
• Severe or debilitating pulmonary disease
• Active fungal, bacterial, and/or viral infection requiring systemic therapy
• Known infection with HIV or active viral hepatitis B or C infection
• Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
• Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug

Egyéb

• Known central nervous system involvement by leukemia or lymphoma
• Pregnant or lactating women

• 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