Phase II Study of Zanubrutinib and Lisocabtagene Maraleucel Liso-cel Combination for Treating Richters Syndrome

What this Trial Is About

Researchers are evaluating how well zanubrutinib combined with lisocabtagene maraleucel liso-cel works for treating patients with Richters syndrome that has returned or does not respond to previous treatments. Richters syndrome is a condition where chronic lymphocytic leukemia or small lymphocytic leukemia changes into an aggressive lymphoma. Zanubrutinib is a kinase inhibitor that blocks proteins helping cancer cells grow, while liso-cel is a CAR T-cell therapy that modifies a patients immune cells to attack cancer. In this phase II study, patients take zanubrutinib by mouth twice daily for up to 90 days and undergo leukapheresis at least 14 days after starting it to collect immune cells. Before receiving liso-cel by intravenous infusion, patients get chemotherapy drugs fludarabine and cyclophosphamide intravenously for three days. The trial includes biopsies of bone marrow and lymph nodes, and imaging scans such as CT, PETCT, or MRI throughout the study to monitor disease and treatment effects. Participants will be followed for two years after completing the treatment, with visits every six months thereafter until disease progression or death. Researchers will measure the overall response rate 90 days after the liso-cel infusion along with safety, survival, progression-free survival, and duration of response over two years. Blood samples will be collected to study immune changes and inflammation related to the treatment.

Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome