IRB #

STUDY00018251

Title

An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Principal Investigator

Alexey Danilov

Study Purpose

The purpose of the study is to learn more about an experimental drug called BGB-3111 (also known as zanubrutinib, and referred to as the study drug) that may be helpful in treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). We will compare the effects, good or bad, of the study drug versus a known standard treatment called bendamustine plus rituximab (B+R) on you and your CLL or SLL. Most participants will receive either the study drug or B+R. However, a smaller group of participants will receive the study drug plus venetoclax, a drug for the treatment of CLL/SLL.

Medical Condition(s)

CLL and SLL

Eligibility Criteria

- Men and women 18 years of age and older who have been diagnosed with CLL or SLL
- No previous treatment for your disease
- Unsuitable for treatment with fludarabine, cyclophosphamide and rituximab (FCR) in the opinion of the study doctor

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Your total length of time in the study, including screening, treatment, and follow-up periods is expected to be up to 3 years.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

BeiGene, Ltd.

Recruitment End

03/01/2022

Compensation Provided

No


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