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
BeOne Medicines
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy * Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 * Adequate organ function Exclusion Criteria: * Known active prolymphocytic leukemia or currently suspect…
Interventions
- DrugSonrotoclax
Administered orally
- DrugObinutuzumab
Administered intravenously
- DrugRituximab
Administered intravenously
- DrugVenetoclax
Administered Orally
Locations (167)
- Uci Health Laguna HillsLaguna Hills, California
- Chao Family Comprehensive Cancer CenterOrange, California
- Stanford Cancer InstitutePalo Alto, California
- Scripps Prebys Cancer CenterSan Diego, California
- Rocky Mountain Cancer Centers (Williams) UsorAurora, Colorado
- Yale University, Yale Cancer CenterNew Haven, Connecticut