BGB-11417-303/CLL-RR1: Sonrotoclax plus anti-CD20 therapies in R/R CLL/SLL
Research type
Research Study
Full title
A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
IRAS ID
1011328
Contact name
Neil Creba-Wright
Contact email
Sponsor organisation
Beigene, Ltd.
Eudract number
2024-517131-52
Clinicaltrials.gov Identifier
Research summary
This study is enrolling patients who have been diagnosed with a cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have already received at least one treatment for their cancer, and who have relapsed, or they were unresponsive to prior treatment (R/R).
Sonrotoclax is an investigational medication which blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain blood cancer cells live and grow. By blocking Bcl-2, sonrotoclax is capable of slowing or stopping cancer cell growth and allowing cancer cell death. This can lead to reduction of CLL disease and improvement in the associated symptoms.
The purpose of this study is to investigate if sonrotoclax in combination with obinutuzumab or rituximab works better and is safe in patients with R/R CLL/SLL, compared with venetoclax plus rituximab which is an approved treatment for this disease.
Participants must be at least 18 years old to take part in the study.
About 630 participants will take part in this study. In the UK, around 28 participants will take part across approximately 7 study sites.
Participants in all groups will have regular checkups to see how their cancer is responding to treatment and to monitor their overall health.
This study is conducted and funded by BeiGene, Ltd.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0495
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion