Study of Zanubrutinib and Pemetrexed for Treating Relapsed or Refractory Primary and Secondary CNS Lymphomas with Induction and Maintenance Therapy

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining pemetrexed and zanubrutinib as induction therapy, followed by zanubrutinib alone as maintenance therapy, in adults with relapsed or refractory primary central nervous system lymphoma PCNSL or isolated central nervous system relapse of B cell lymphoma SCNSL. The study observes how well patients respond, whether their disease improves or worsens, and their survival rates while monitoring safety and side effects. Participants receive induction therapy that includes oral zanubrutinib and intravenous pemetrexed over 4 to 8 cycles. After induction, participants are grouped into three cohorts based on standard care one undergoes autologous stem cell transplant ASCT, another receives whole brain radiation therapy WBRT followed by zanubrutinib maintenance, and the last continues with zanubrutinib maintenance alone until disease progression. Throughout the study, participants undergo assessments of their response to treatment, including best overall response rates and complete response rates at various points, lasting up to 5 years. Researchers also monitor progression-free survival, overall survival, and any dose-limiting toxicities. Safety is closely tracked, and participants are followed regularly for up to five years to evaluate long-term outcomes and benefits of the treatment regimen.

Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas