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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Bendamustine Hydrochloride; Rituximab; Venetoclax; Zanubrutinib

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 trial.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.