A Phase 3 Study Comparing Sonrotoclax Plus Obinutuzumab or Rituximab With Venetoclax Plus Rituximab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with either obinutuzumab or rituximab compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This Phase 3 randomized study aims to understand which combination offers better progression-free survival and treatment outcomes in patients who have undergone prior therapies. The study has four treatment groups sonrotoclax combined with obinutuzumab, sonrotoclax combined with rituximab, sonrotoclax plus obinutuzumab with treatment guided by minimal residual disease evaluation, and venetoclax combined with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are administered intravenously. Participants receive these treatments according to their assigned group as part of this clinical research. Participants will be monitored for progression-free survival, overall survival, response rates, and minimal residual disease status over several months up to several years. Safety assessments include tracking treatment-emergent adverse events. Quality of life and symptom burden will be evaluated using questionnaires. The study involves regular visits for treatment administration and assessments, with follow-up extending up to 84 months to observe long-term outcomes.

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)