NCT07523737 Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma
| NCT ID | NCT07523737 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Primary Central Nervous System Lymphoma (PCNSL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 43 participants in total. It began in 2026-04-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Liang Wang, M.D.
PRINCIPAL INVESTIGATOR
Beijing Tongren Hospital
Frequently Asked Questions
Who can join the NCT07523737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Central Nervous System Lymphoma (PCNSL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07523737 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07523737 currently recruiting?
Yes, NCT07523737 is actively recruiting participants. Contact the research team at wangliangtrhos@126.com for enrollment information.
Where is the NCT07523737 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07523737 clinical trial?
NCT07523737 is sponsored by Beijing Tongren Hospital. The principal investigator is Liang Wang, M.D. at Beijing Tongren Hospital. The trial plans to enroll 43 participants.