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

ID#: NCT03336333

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: November 02, 2017

End Date: October 01, 2022

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