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New treatment option for Primary Central Nervous System Lymphoma (PCNSL)
Official title Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT07523737
What this study is testing
What is Pomalidomide?
Pomalidomide is an investigational medicine, being studied as a potential treatment for primary central nervous system lymphoma (pcnsl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.