A Phase 3 Study Comparing Sonrotoclax Plus Anti-CD20 Antibodies Versus Venetoclax Plus Rituximab in Adults With Relapsed or Refractory Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

What this Trial Is About

Researchers are evaluating different treatment combinations for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This phase 3 study compares how well sonrotoclax combined with either obinutuzumab or rituximab works against venetoclax plus rituximab. The study also monitors the safety of these treatments as part of the comparison. Participants will receive one of four treatment combinations sonrotoclax with obinutuzumab, sonrotoclax with rituximab, sonrotoclax with obinutuzumab guided by minimal residual disease evaluation, or venetoclax with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are given intravenously. Treatment continues with evaluations based on disease response and minimal residual disease status. During the study, participants will have regular assessments including disease progression, response rates, overall survival, quality of life, and safety monitoring. These assessments include clinical evaluations, laboratory tests, and quality of life questionnaires. The primary outcome is progression-free survival up to about 51 months, with other outcomes assessed up to 84 months. Participants are monitored from study start through treatment and follow-up periods, which may last several years.

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)