A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.
In this study, participants with CLL without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.
The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. Approximately 652 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined criteria may apply
La Jolla, California 92093-1503, United States
Washington D.C., District of Columbia 20007-2113, United States
Hackensack, New Jersey 07601, United States
Columbus, Ohio 43210-1240, United States
Bedford PK, South Australia SA 5042, Australia
Salzburg, 5020, Austria
Botucatu, 18618687, Brazil
Ribeirão Preto, 14051-140, Brazil
Greenfield Park, Quebec J4V 2H1, Canada
SaintJerome, Quebec J7Z 5T3, Canada
Québec, G1J 1Z4, Canada
Jieyang, Guangdong 522000, China
Wuhan, Hubei 430030, China
Chengdu, Sichuan 610071, China
Hangzhou, Zhejiang 310003, China
PLZE, 323 00, Czechia
ClermontFerrand, 63100, France
Esseylesnancy, 54270, France
Rennes Cedes, 35000, France
VandoeuvrelesNancy, 54511, France
AmagasakiCity, Hyōgo 660-8550, Japan
Iseharashi, Kanagawa 259-1193, Japan
Kurashikishi, Okayama-ken 710-8602, Japan
ChuoKu, Tokyo 104-0045, Japan
Sgravenhage, 2545 AA, Netherlands
Lodz, 93-513, Poland
IlsandongGu GoyangSi, Gyeonggi-do 10408, South Korea
SeochoGu, Seoul Teugbyeolsi 06591, South Korea
SeodaemunGu, Seoul Teugbyeolsi 03722, South Korea
SongpaGu, Seoul Teugbyeolsi 05505, South Korea