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)
Phase 3
630
about 6.6 years
18+
33 sites in CA, CO, CT +17
What this study is about
Researchers are testing whether sonrotoclax plus obinutuzumab or sonrotoclax plus rituximab are more effective than venetoclax plus rituximab in treating adults with relapsed and/or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. The trial 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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Obinutuzumab
- 2.Take Rituximab
- 3.Take Sonrotoclax
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
obinutuzumab, rituximab (Monoclonal antibody; targets CD20 on B-cells to destroy them), bcl-2 inhibitor, venetoclax
injection, intravenous, infusion, oral
Primary: Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
Secondary: Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales, Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life and Physical Functioning Scales, Complete Response Rate as assessed by BIRC for Arm A versus Arm D, Duration of Response (DOR) per BIRC and by INV, Number of Participants with Treatment-Emergent Adverse Events (TEAEs), OS for Arm A versus Arm B, OS for Arm B versus Arm D, OS for Arm C versus Arm D
Oncology