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

• Status: Recruiting
• Trial end date: 2026-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Treatments: Methotrexate; Rituximab

Criteria

Inclusion Criteria:

• primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy;

• Aged 18-70 years

• Signature of informed consent;

• At least one measurable lesion;

• Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin<2XULN,ALT<4XULN,AST 4XULN

• The expected survival time is at least 3 months

Exclusion Criteria:

• Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX

• History of other malignancies that may affect the compliance of the research protocol or the analysis of the results

• Severe cardiac insufficiency

• Other antitumor treatments were used

• Human immunodeficiency virus(HIV)antibody is positive

• Pregnant or lactating women

• Researchers consider if anyone not suitable for enrollment.