Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Primary Central Nervous System Lymphoma (PCNSL) | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 / PD-L1 monoclonal antibody | Drug | — | UNRESOLVED |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
| XPO1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PPS group
- description
- All enrolled patients may initiate induction therapy after completing baseline imaging and relevant laboratory examinations: Pomalidomide: 4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles; Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles; PD-1 monoclonal antibody: tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles. During induction therapy, patients who achieve complete response (CR) may discontinue from the study to receive consolidation therapy with autologous hematopoietic stem cell transplantation (AHSCT) or dose-optimized whole-brain radiotherapy (WBRT), at the investigator's discretion or the patient's choice. For patients not discontinuing for consolidation therapy, maintenance therapy may be administered after 6 cycles of induction therapy: pomalidomide 4 mg every other day (qod) plus selinexor 40-60 mg once weekly (qw), until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Pomalidomide
- Drug: PD-1 / PD-L1 monoclonal antibody
- Drug: XPO1 inhibitor
Primary outcomes (1)
- measure
- best overall response rate (ORR) as of 6 cycles of PPS
- timeFrame
- From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
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