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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
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
Details
| Lead sponsor | BeOne Medicines |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 630 |
| Start date | 2025-06-11 |
| Completion | 2031-12 |
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Interventions
- Sonrotoclax
- Obinutuzumab
- Rituximab
- Venetoclax
Primary outcomes
- Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D — Up to approximately 51 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, South Korea, Spain, Sweden, United Kingdom