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RECRUITING
NCT07523737
PHASE2

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

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

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.

Official title: Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2026-04-01

Completion Date

2028-08-31

Last Updated

2026-04-15

Healthy Volunteers

No

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

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China