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

Primary Central Nervous System Lymphoma Clinical Trial

Official title:
Orelabrutinib, Rituximab and Methotrexate (OR-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma: a Single Arm, Multicenter, Phase 2 Study

Clinical Trial 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.

Clinical Trial Description

This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of Orelabrutinib, rituximab and methotrexate as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 28 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by Orelabrutinib maintenance chemotherapy up to one year. After 6 cycles of induction chemotherapy, autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be performed for transplantation eligible patients . Follow-ups should be taken up to the first 2 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events. ;

Study Design

Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma
Clinical Trial Details
NCT number NCT05600660
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wenbin Qian, prof.
Phone +8613605801032
Email qianwb@zju.edu.cn
Status Recruiting
Phase Phase 2
Start date August 1, 2022
Completion date December 31, 2027
View Details
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