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A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 suspected Richter's transformation * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug * Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent * Known central nervous system involvement by CLL/SLL * Severe or debilitating pulmonary disease * Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
About the study
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.
What is being tested
- Sonrotoclax (drug)
- Obinutuzumab (drug)
- Rituximab (drug)
- Venetoclax (drug)
Sponsor: BeOne Medicines · Participants: 630 · Started: Jun 11, 2025
Contact the study team
- Study Director · Phone: 1-877-828-5568
Official record on ClinicalTrials.gov — NCT06943872
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.