Phase 2 Study of Orelabrutinib, Rituximab, and Methotrexate as First Treatment for Newly Diagnosed Primary Central Nervous System Lymphoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combination chemotherapy regimen called OR-MTX, which includes Orelabrutinib, Rituximab, and Methotrexate, as the first treatment for patients newly diagnosed with primary central nervous system lymphoma. This phase 2, single-arm, multicenter study plans to enroll 28 patients to better understand how well this regimen works and its side effects. The main goal is to measure the objective response rate, with additional outcomes including progression-free survival, overall survival, and treatment-related adverse events. Participants will receive six cycles of the OR-MTX chemotherapy regimen as induction treatment. After these six cycles, patients who are eligible may undergo autologous hematopoietic stem cell transplantation AHSCT. Following this, Orelabrutinib will be given as maintenance therapy for up to one year or until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up. The study includes a follow-up period lasting up to two years after treatment. During the study, participants will be closely monitored through regular medical assessments, imaging tests such as MRI, and laboratory evaluations to track their response to treatment and watch for side effects. Researchers will evaluate the objective response rate at the end of the six chemotherapy cycles. Safety and other outcomes will be assessed throughout the treatment and follow-up periods. The total participation time may extend up to two years to allow for thorough evaluation of long-term effects and disease control.

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma