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

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

May 30, 2023

Study Completion Date

May 30, 2026

Conditions
Primary Central Nervous System Lymphoma
Interventions
DRUG

Orelabrutinib,Rituximab and Methotrexate

Orelabrutinib, Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma. The response will be evaluated every 2 cycles. Patients who achieved complete remission (CR) or partial remission (PR) will receive further treatment, and there are 6 cycles of RMO regimen for the induction. The patients with stable disease (SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again. After 6 cycles, the patients who receive CR or PR, can tolerate Autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be candidates of high-dose chemotherapy and stem rescue. The patients who achieve CR or PR, cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance. The patients with SD or PD will receive salvage regimen.

Trial Locations (1)

100071

RECRUITING

Hospital 307, Beijing

All Listed Sponsors
lead

Affiliated Hospital to Academy of Military Medical Sciences

OTHER