Phase II Study of Zanubrutinib, Rituximab, Lenalidomide, and Tislelizumab for Relapsed or Refractory Follicular Lymphoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of a combination treatment including zanubrutinib, rituximab, lenalidomide ZR, and tislelizumab in patients with relapsed or refractory follicular lymphoma who have had at least one prior systemic therapy. This Phase II, single-center, open-label study aims to understand how well this regimen works and how safe it is for these patients. Participants will receive six 21-day treatment cycles of the four-drug combination during the induction phase. Zanubrutinib is taken orally twice daily, rituximab is given intravenously on specific days during cycles 1 to 6 and possibly beyond, lenalidomide is taken orally once daily during cycles 1 to 6, and tislelizumab is infused intravenously every three weeks. After induction, patients who achieve complete response, partial response, or stable disease will enter maintenance therapy with zanubrutinib and tislelizumab for up to one year or until progression or unacceptable side effects. Throughout the study, patients will undergo disease assessments by CT or PET-CT scans to evaluate tumor response using the 2014 Lugano criteria. Safety and efficacy will be closely monitored, including response rates and progression-free survival up to two years. Treatment-related adverse events will be recorded from the first dose until 30 days after stopping treatment. The total study duration includes induction, maintenance, and follow-up periods as outlined in the protocol.

Efficacy and Safety of Zanubrutinib, Rituximab, and Lenalidomide (ZR²) in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma