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NCT07002099

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

Recruiting now Phase 2 Last updated 3 June 2025
What this trial tests

Phase 2 trial testing Selinexor + High-dose Methotrexate + Rituximab + WBRT in Lymphomas in 26 participants. Currently enrolling.

Timeline
1 June 2025
Primary endpoint
30 December 2028
31 December 2028

Quick facts

Lead sponsorSecond Affiliated Hospital of Soochow University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment26
Start date1 June 2025
Primary completion30 December 2028
Estimated completion31 December 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital of Soochow University

Who can join

18 and older, any sex, with Lymphomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Lymphomas

Currently open trials in the same condition.

Other Second Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07002099.

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