Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study
Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed/refractory (R/R) disease. Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R/R PCNSL, aiming to provide a new effective treatment.
• Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL).
• Disease progression or relapse after prior treatment with high-dose methotrexate and/or BTK inhibitors.
• Age between 18 and 75 years.
• ECOG performance status score 0-4.
• Expected overall survival \> 3 months.
• No known hypersensitivity to any study drug.
• White blood cell count ≥ 3×10⁹/L; absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L.
• Serum creatinine ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mL/min.
• ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 2× ULN.
• Signed written informed consent.