Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

• Status: Recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response [PR] or better) after 4 cycles of POR.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Tiantan Hospital; Sanbo Brain Hospital Capital Medical University
• Treatments: Methotrexate; Pomalidomide; Rituximab

Criteria

Inclusion Criteria:

• • Newly diagnosed primary central nervous system lymphoma

• Pathological type is B cell lymphoma

• Age 18-70 years

• Demonstrate adequate marrow hemopoietic function as defined below:WBC>3.0×109/L,ANC>1.5×109/L,HGB>90g/L,PLT>80×109/L

• Demonstrate adequate organ function as defined below: cardiac function grade 0-2（NYHA）；SpO2>88%( natural state)；ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2

• Having at least one measurable lesions

• Sign the Informed consent

Exclusion Criteria:

• • The pathological diagnosis was T-cell lymphoma.

• systemic lymphoma involved CNS

• Pre-existing uncontrolled active infection

• Acute myocardial infarction or unstable angina within 6 months; Uncontrolled hypertension and arrhythmia

• Active bleeding

• Allergic to any component of the investigational product.

• Subjects who are suspected to be unable to comply with the study protocol

• Pregnancy or active lactation