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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 (CLL / SLL)

Cancer Type
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
BGB-3111-304 (primary)
Study Sponsor


This study will enroll subjects with previously untreated CLL / SLL into two cohorts (Cohort 1 without del[17p] and Cohort 2 with del[17p]). Cohort 1 subjects will receive either "BGB-3111 alone" or "bendamustine (B) and rituximab (R)". Cohort 2 subjects will receive BGB-3111 alone. The primary purpose is to evaluate the efficacy and safety of BGB-3111 versus bendamustine and rituximab in Cohort 1.


This is a global phase 3, open label, randomized study of BGB-3111 versus bendamustine plus rituximab (B+R) in subjects with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including subjects without del(17p) [Cohort 1] and subjects with del(17p) [Cohort 2]. Subjects in Cohort 1 are randomized 1:1 to BGB-3111 (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Subjects in Cohort 2 receive treatment with BGB-3111.

Treatment Sites in Georgia

Augusta University Medical Center

1120 15th Street
Augusta, GA 30912

Emory University Hospital - Atlanta

1364 Clifton Road NE
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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