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drugset / Trial / NCT04120350

R2-MTX With Lenalidomide Maintenance in Newly-diagnosed PCNSL：a Multicenter Phase Ib/II Stuty

NCT04120350 ↗

Phase 1/2 Unknown 47 enrolled Peking Union Medical College Hospital Beijing Hospital · collabBeijing Tiantan Hospital · collabChinese PLA General Hospital · collabPeking University First Hospital · collabPeking University Third Hospital · collabXuanwu Hospital, Beijing · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter prospective single arm phase Ib/II study, and the purpose of this study is to evaluate the safety and efficiency of R2-MTX regimen (rituximab \& lenalidomide \& methotrexate) combined with lenalidomide maintenance in newly-diagnosed primary central nervous system lymphoma. 2-year Progression free survival (PFS) of the cohort is the primary endpoint.

Timeline

Start
2019-08-16
Primary completion
2022-08
Completion
2024-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 15 mg Oral
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Methotrexate Small molecule 3.5 g Intravenous
Subject Rituximab Monoclonal antibody 375 mg Intravenous

Indications

primary central nervous system lymphoma