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Brief Title: Rituximab,Methotrexate and Lenalidomide in Newly Diagnosed Primary Central Nervous System Lymphoma
Official Title: Efficacy and Safety Study of Rituximab, Methotrexate and Lenalidomide Chemotherapy(R2-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma:a Single Arm, Multicenter, Phase 2 Study
Study ID: NCT04934579
Brief Summary: It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of R2-MTX chemotherapy(Lenalidomide, Rituximab and Methotrexate)as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.
Detailed Description: This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of rituximab, methotrexate and lenalidomide as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 40 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by 4 cycles of maintenance chemotherapy. Follow-ups should be taken up to the first 3 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China