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)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Uci Health Laguna Hills, Laguna Hills, California, United States
• Chao Family Comprehensive Cancer Center, Orange, California, United States
• Stanford Cancer Institute, Palo Alto, California, United States
• Scripps Prebys Cancer Center, San Diego, California, United States
• Rocky Mountain Cancer Centers (Williams) Usor, Aurora, Colorado, United States
• Yale University Yale Cancer Center, New Haven, Connecticut, United States
• Eastern Connecticut Hematology and Oncology, Norwich, Connecticut, United States
• Cleveland Clinic Florida, Weston, Florida, United States
• Northwestern University, Chicago, Illinois, United States
• Illinois Cancer Specialists (Niles) Usor, Niles, Illinois, United States
• University of Louisville, Brown Cancer Center, Louisville, Kentucky, United States
• Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States

+ 175 more sites.

Who to contact

Study Director · 1-877-828-5568 · clinicaltrials@beonemed.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06943872.