Study of Zanubrutinib and Tislelizumab With or Without Sonrotoclax for Treating Richter Transformation in Adults

What this Trial Is About

Researchers are evaluating the combination of zanubrutinib, a BTK inhibitor, and tislelizumab, a PD-1 inhibitor, with or without sonrotoclax, a Bcl-2 inhibitor, for patients with Richter Transformation RT, a challenging progression of chronic lymphocytic leukemia CLL. This Phase II trial aims to assess the safety and effectiveness of these treatments, as current options for RT have limited success and poor patient outcomes. The German CLL Study Group is leading this effort to find improved therapies for this serious condition. Participants receive treatment in cycles lasting 21 days. One group gets tislelizumab and zanubrutinib for six induction cycles followed by six consolidation cycles, then maintenance therapy until disease progression, intolerance, or stem cell transplantation. Another group receives the same treatment plus sonrotoclax with a detailed ramp-up dosing in the first cycle and continued dosing in subsequent cycles under the same schedule. The trial is open-label and non-randomized. During the study, patients undergo evaluations of response rates after induction and consolidation therapies using established lymphoma criteria. Researchers will monitor progression-free survival, overall survival, time to next treatment, adverse events, and duration of response for up to 15 months. Participants are followed closely with clinical assessments to track treatment effects and safety throughout the trial and maintenance periods.

Efficacy and Safety of Zanubrutinib Plus Tislelizumab Treatment with or Without Sonrotoclax for Patients with Richter Transformation