Actively Recruiting
Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma
Led by Beijing Tongren Hospital · Updated on 2026-04-15
43
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 greater than 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.
You will not qualify if you...
- Presence of another malignant tumor requiring active pharmacological or surgical intervention at present.
- Female patients who are pregnant or breastfeeding.
- Patients of reproductive potential unwilling or failing to use effective contraceptive measures.
- Known hypersensitivity to any study drug or excipient ingredients.
- Active infection as determined by the investigator.
- History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or organ transplantation.
- History of neurological or psychiatric disorders, including epilepsy or dementia.
- History of autoimmune diseases except Hashimoto's thyroiditis or thyroid dysfunction.
- Any severe comorbidity that may compromise safety or interfere with study completion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
Liang Wang, M.D.
CONTACT
J
Jia Cong, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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