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

PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 30, 2028

Study Completion Date

December 31, 2028

Conditions
Lymphomas
Interventions
DRUG

Selinexor + 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."

Trial Locations (1)

215000

RECRUITING

The Second Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

Second Affiliated Hospital of Soochow University

OTHER

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 | Biotech Hunter | Biotech Hunter