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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

NCT07523737 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)
  • Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

DRUG

Pomalidomide

4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles

DRUG

PD-1 / PD-L1 monoclonal antibody

tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles

DRUG

XPO1 inhibitor

Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Liang Wang, M.D. · Beijing Tongren Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-03-31
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523737 on ClinicalTrials.gov