drugset
drugset / Trial / NCT05549284

Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)

NCT05549284 ↗

Phase 2 Unknown 36 enrolled Affiliated Hospital to Academy of Military Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.

Timeline

Start
2022-06-01
Primary completion
2023-05-30
Completion
2026-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 3.5 mg/m2 —
Subject Orelabrutinib Small molecule 150 g —
Subject Rituximab Monoclonal antibody 375 mg/m2 —

Indications

primary central nervous system lymphoma