IRB #

STUDY00019585

Title

A Phase 3, Randomized Study of Zanubrutinib (BGB 3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Principal Investigator

Stephen Spurgeon

Study Purpose

The purpose of the study is to compare 2 drugs, an investigational drug called zanubrutinib and an FDA approved drug called ibrutinib, in treating CLL/SLL. The two main objectives of the study are to find out how effectively the study drug controls CLL/SLL, and to compare the side effects of each drug. You will be randomly assigned by a computer to receive either the study drug or ibrutinib. Neither you nor the investigator can choose whether you get the study drug or ibrutinib. You will have an equal chance of being in either group.

Medical Condition(s)

Relapsed and/or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Eligibility Criteria

- You must be at least 18 years of age and diagnosed with relapsed/refractory CLL/SLL
- You must be relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
- You must not have had prior treatment with a BTK inhibitor, such as ibrutinib or acalabrutinib

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You will receive either the study drug or ibrutinib until your disease gets worse or the side effects become too severe. After you are done taking the drug, you will be followed long-term for up to 7 years.

Minors Included

No

Contact

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

Sponsor

BeiGene, Ltd.

Recruitment End

01/01/2022

Compensation Provided

No


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