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.
Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;
Female patients who are pregnant or breastfeeding;
Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures;
Known hypersensitivity to any study drug or any excipient ingredients of these products;