NCT04934579

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
DRUG	Lenalidomide	25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
DRUG	Methotrexate	3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-10-15
• Completion: 2022-11-15
• First posted: 2021-06-22
• Last updated: 2022-11-23

Locations

1 site across 1 country: China