Status:
RECRUITING
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)
Lead Sponsor:
BeiGene
Collaborating Sponsors:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT06943872
Start Date
June 11 2025
End Date
December 1 2031
Last Update
December 23 2025
Active Locations (88)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868-3201
2
Stanford Cancer Institute
Palo Alto, California, United States, 94304-2205
3
Scripps Prebys Cancer Center
San Diego, California, United States, 92103-2106
4
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States, 80012-5405