OncoMatch/Clinical Trials/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
Is NCT07002099 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Selinexor + High-dose Methotrexate + Rituximab + WBRT for lymphomas.
Treatment: Selinexor + High-dose Methotrexate + Rituximab + WBRT — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: systemic therapy
Prior systemic therapy for CNS lymphoma
Cannot have received: selective inhibitor of nuclear export (SINE) compounds (selinexor)
Prior treatment with selective inhibitor of nuclear export (SINE) compounds, including selinexor
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 80 g/L
Kidney function
Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if liver involvement); ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN if liver involvement)
Cardiac function
No clinically significant or unstable cardiovascular disease, including: myocardial infarction within 6 months, unstable angina within 3 months, uncontrolled arrhythmias (e.g., ventricular tachycardia/fibrillation), congestive heart failure NYHA class ≥ III, LVEF < 50% by echocardiography
Adequate organ function, including: ANC ≥ 1.0 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 80 g/L; Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if liver involvement); ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN if liver involvement); Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); INR ≤ 1.5 × ULN; APTT within 10 seconds of normal. Clinically significant or unstable cardiovascular disease [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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