Last updated on July 2019

A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03336333

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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