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Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma

RecruitingPhase 2Ages 18 Years - 75 YearsAllBeijing Tongren Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 3ร—10โน/L; absolute neutrophil count โ‰ฅ 1.0ร—10โน/L; platelet count โ‰ฅ 50ร—10โน/L. * Serum creatinine โ‰ค 1.5 mg/dL; creatinine clearance โ‰ฅ 50 mL/min. * ALT and AST โ‰ค 3ร— upper limit of normal (ULN); total bilirubin โ‰ค 2ร— 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.
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What it tests

  • Pomalidomide
  • PD-1 / PD-L1 monoclonal antibody
  • XPO1 inhibitor
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Where

1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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