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)
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)
To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.
This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in participants with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including participants without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3]. Participants in Cohort 1 are randomized 1:1 to zanubrutinib (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. Participants in Cohort 2 will receive treatment with zanubrutinib. Participants in Cohort 3 will receive treatment with zanubrutinib and venetoclax.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Salzburg, 5020, Austria
Chongqing, Chongqing Municipality 400037, China
Wuhan, Hubei 430022, China
Hangzhou, Zhejiang 310003, China
PierreBenite, 69495, France
Poitiers, 86000, France
VandoeuvrelesNancy, 54511, France
Sochi, Krasnodarskiy Kray 354057, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603126, Russia
Penza, Penza Oblast 440071, Russia
Perm, Permskiy Kray 614077, Russia
Kemerovo, Pskov Oblast 650066, Russia
Saint Petersburg, Sankt-Peterburg 191024, Russia
Kazan, Tambov Oblast 420029, Russia
Volgograd, Volgograd Oblast 400138, Russia
Greater Manchester, M20 4BX, United Kingdom
Maidstone, ME16 9QQ, United Kingdom