RecruitingPhase 2NCT05549284

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

a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Enrollment

36 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — orelabrutinib, rituximab, and high-dose methotrexate — in people newly diagnosed with primary central nervous system lymphoma (PCNSL), a rare type of lymphoma that forms in the brain. **You may be eligible if...** - You have been newly diagnosed with diffuse large B-cell lymphoma of the brain (PCNSL), confirmed by brain biopsy - You are between 18 and 70 years old - You have at least one measurable lesion in the brain - Your blood counts and liver function are within acceptable ranges - Your expected survival is at least 3 months **You may NOT be eligible if...** - You are allergic to any of the three study drugs - You have had other cancers that may interfere with the study - You have severe heart failure - You are HIV-positive - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib,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.