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)
Recruiting now · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
In brief
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.
Key facts
- Study ID
- NCT06943872
- Run by
- BeOne Medicines
- People needed
- 630
- Starts
- 2025-06-11
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
- Stanford Cancer Institute — Palo Alto, California, United States (enrolling)
- Scripps Prebys Cancer Center — San Diego, California, United States (enrolling)
- Rocky Mountain Cancer Centers (Williams) Usor — Aurora, Colorado, United States (enrolling)
- Yale University Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Eastern Connecticut Hematology and Oncology — Norwich, Connecticut, United States (enrolling)
- Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Illinois Cancer Specialists (Niles) Usor — Niles, Illinois, United States (enrolling)
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
- Mission Cancer and Blood — Waukee, Iowa, United States (enrolling)
- University of Louisville, Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
- Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States (enrolling)
- The University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- Beth Israel Deaconess Medical Center (Bidmc) — Boston, Massachusetts, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- The Cancer and Hematology Centers — Grand Rapids, Michigan, United States (enrolling)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- Sidney Kimmel Comprehensive Cancer Center Washington Twp — Sewell, New Jersey, United States (enrolling)
- Christus St Vincent Regional Cancer Center — Santa Fe, New Mexico, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States (enrolling)
- Optum Medical Care, Pc — Westbury, New York, United States (enrolling)
- University of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- Levine Cancer Center — Charlotte, North Carolina, United States (enrolling)
- Uci Health Laguna Hills — Laguna Hills, California, United States (enrolling)
Full record on ClinicalTrials.gov
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