BGB-11417-301 Phase 3 Study of Sonrotoclax( BGB-11417) Plus Zanubrutinib Previously untreated CLL
Research type
Research Study
Full title
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
IRAS ID
1008816
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene Ltd
Eudract number
2023-506948-17
Clinicaltrials.gov Identifier
Research summary
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. CLL patients suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. CLL patients have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong patient life and control disease-related symptoms.\nIn this study, CLL patients without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first treatment or receive sonrotoclax plus zanubrutinib. it is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL. \nThe main purpose of this study is to compare the duration the patients live without the CLL getting worse between patients who received venetoclax plus obinutuzumab versus sonrotoclax plus zanubrutinib. Approximately 640 patients will be included in this study around the world. Patients will have equal chance to be allocated to receive either of the treatment combinations.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0379
Date of REC Opinion
12 Dec 2023
REC opinion
Further Information Favourable Opinion