Pomalidomide, anti–PD‑1 antibody, and selinexor for relapsed/refractory primary CNS diffuse large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, single‑arm phase II trial gives a combination of pomalidomide, an anti–PD‑1 monoclonal antibody, and the XPO1 inhibitor selinexor to adults with relapsed or refractory PCNSL‑DLBCL after prior high‑dose methotrexate and/or BTK inhibitors. The study primarily measures tumor response rate and safety, with scheduled brain MRIs, neurologic exams, laboratory monitoring, and adverse event reporting. Eligible participants are 18–75 years old with ECOG 0–4 and adequate hematologic, renal, and hepatic function. Treatment is administered per protocol with ongoing imaging and clinical follow‑up to capture duration of response and survival outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tongren Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Liang Wang, M.D. — Beijing Tongren Hospital
• Study coordinator: Liang Wang, M.D.
• Email: wangliangtrhos@126.com
• Phone: +861058266633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.