A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Zanubrutinib; Bendamustine; Rituximab; Venetoclax
Intervention description: Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day); Administered intravenously (IV) at a dose of 90 mg/m^2/day on the first 2 days of each cycle for 6 cycles.; Administered intravenously (IV) at a dose of 375 mg/m^2 on day 0 of cycle 1, and at a dose of 500 mg/m^2 on day 1 of cycles 2 to 6; 400 mg tablets administered orally once daily.
Intervention MeSH terms: Rituximab; Venetoclax; Bendamustine Hydrochloride; Zanubrutinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 590.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: zanubrutinib; BTK inhibitor; bendamustine; rituximab; venetoclax; BGB-3111; Phase 3

Summary:

      To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with
      previously untreated CLL/SLL, as measured by progression free survival assess by Independent
      Central Review.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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

        Key Exclusion Criteria:

          -  Previous systemic treatment for CLL/SLL

          -  Requires ongoing need for corticosteroid treatment

          -  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

          -  History of stroke or intracranial hemorrhage within 6 months before the first dose of
             study drug

          -  Severe or debilitating pulmonary disease

          -  Inability to swallow capsules or disease affecting gastrointestinal function

          -  Active infection requiring systemic treatment

          -  Known central nervous system involvement by leukemia or lymphoma

          -  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

          -  Major surgery ≤ 4 weeks prior to start of study treatment

          -  Pregnant or nursing females

          -  Vaccination with live vaccine within 35 days prior to the first dose of study drug.

          -  Ongoing alcohol or drug addiction

          -  Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as
             applicable) or any other ingredients of the study drugs

          -  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.