Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

PCNSL Clinical Trial

Official title: Efficacy and Safety Study of Lenalidomide Plus Rituximab and Methotrexate Chemotherapy（R2-MTX） Versus Rituximab and Methotrexate Chemotherapy（R-MTX） in Newly Diagnosed Primary Central Nervous System Lymphoma: a Multicenter, Open-Label, Randomised Phase 2 Study

Status Recruiting

Clinical Trial Summary

It is a multicenter, open-Label, randomised phase 2 study to compare the efficacy and safety study of R2-MTX chemotherapy（Lenalidomide, Rituximab and Methotrexate）with R-MTX chemotherapy（Rituximab and Methotrexate ）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma.2-year Progression free survival (PFS) is the primary endpoint.

Clinical Trial Description

This is a multicenter, open-Label, randomised phase 2 study designed to evaluate the efficacy and safety of rituximab plus methotrexate with or without lenalidomide as first-line regimens in the treatment of primary central nervous system lymphoma. A total of 240 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 endpoints were 2-year PFS rate and and secondary endpoints including objective response rate (ORR), PFS, overall survival (OS), and adverse events. ;

Related Conditions & MeSH terms

• PCNSL

• NCT number: NCT04481815
• Study type: Interventional
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xianggui Yuan, MD,PhD
• Phone: +8613989883884
• Email: yuanxg@zju.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2020
• Completion date: December 30, 2025