Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma
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
Beijing Tongren Hospital
43 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria9
- 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;
- Active infection (determined by the investigator);
- History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or history of organ transplantation;
- Documented history of neurological or psychiatric disorders, including epilepsy or dementia;
- Documented history of autoimmune diseases (except Hashimoto's thyroiditis or thyroid dysfunction);
- Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.
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Interventions
4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles
tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles
Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07523737