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

Phase 2 Recruiting 28 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University

NaSingle-groupOpen-labelTreatment

Summary

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, 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.

Timeline

Start: 2022-08-01
Primary completion: 2025-12-31
Completion: 2027-12-31

Publications

Xiao XB, Weng YQ, Jiang HW, Li X, Xie J, Bao CQ, Qian WB. Orelabrutinib combined with rituximab and high-dose methotrexate as induction therapy in newly diagnosed primary central nervous system lymphoma. Invest New Drugs. 2025 Jun;43(3):679-686. doi: 10.1007/s10637-025-01548-1. Epub 2025 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methotrexate	Small molecule	3.5 g	Intravenous
Subject	Orelabrutinib	Small molecule	150 mg	Oral
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications