RecruitingPhase 2NCT07002099

Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study

Sponsor

Second Affiliated Hospital of Soochow University

Enrollment

26 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphomas

Summary

This phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. The study will assess the safety and effectiveness of combining selinexor (an oral selective nuclear export inhibitor) with high-dose methotrexate and rituximab chemotherapy, followed by low-dose whole-brain radiotherapy (WBRT). Selinexor has shown promise in enhancing the effects of chemotherapy and radiation in blood cancers. Patients enrolled in this open-label, single-arm, multicenter study will receive up to six 21-day treatment cycles. Those who respond well will undergo reduced-dose WBRT and continue selinexor as maintenance therapy. The study will measure how many patients respond to the treatment (overall response rate), how long the response lasts (progression-free survival), overall survival, and safety. This research aims to provide a less toxic and more effective option for treating CNSL in patients who are older or medically unfit for transplantation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase II study is testing a new combination treatment — selinexor (a targeted drug), high-dose methotrexate, and rituximab, combined with radiation — for people with lymphoma that has spread to the brain or spinal fluid (CNS lymphoma) who are not suitable for a stem cell transplant. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of primary or secondary CNS lymphoma - You have at least one measurable brain lesion or positive spinal fluid results - You are not eligible for (or have declined) a stem cell transplant - Your ECOG performance status is 0–3 and you have adequate organ function - You have not received prior systemic therapy for CNS lymphoma **You may NOT be eligible if...** - Your lymphoma is only in the eye - You have active systemic lymphoma outside the brain - You have uncontrolled pressure in the brain - You have had a heart attack within 6 months, unstable angina, or uncontrolled heart arrhythmia - 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

DRUGSelinexor + High-dose Methotrexate + Rituximab + WBRT

Rituximab 375 mg/m² intravenously on Day 0 of each 21-day cycle High-dose Methotrexate (HD-MTX) 3.5 g/m² intravenously over 4 hours on Day 1 of each cycle Selinexor 80 mg orally once weekly (on Days 1, 8, and 15) during each cycle Treatment is administered every 21 days for up to 6 cycles. Tumor response will be evaluated every 3 cycles. Patients who achieve a partial response (PR) or better will undergo consolidative low-dose whole-brain radiotherapy (WBRT) at 23.4 Gy in 13 fractions.