A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Korábbi kezelés

• Previous systemic treatment for CLL/SLL
• Requires ongoing need for corticosteroid treatment
• History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug
• Major surgery ≤ 4 weeks prior to start of study treatment
• Vaccination with live vaccine within 35 days prior to the first dose of study drug.
• Ongoing alcohol or drug addiction
• 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.

Más betegség

• 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
• Severe or debilitating pulmonary disease
• Inability to swallow capsules or disease affecting gastrointestinal function
• Active infection requiring systemic treatment
• 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
• Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs

Egyéb

• Known central nervous system involvement by leukemia or lymphoma
• Pregnant or nursing females

• 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