Clinical Trial

Pomalidomide Plus Rituximab Maintenance in Young High-Risk Newly Diagnosed DLBCL After First-Line Response

Not Yet Recruiting Phase 4
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Summary
This is a prospective, single-arm, single-center clinical study evaluating pomalidomide combined with rituximab as maintenance treatment in young high-risk patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) who have achieved at least a partial response after first-line therapy. Eligible participants will receive rituximab 375 mg/m² by intravenous infusion on Day 1 every 8 weeks and pomalidomide 4 mg orally once daily on Days 1 to 21 of each 28-day cycle. Maintenance treatment is planned for 24 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur. The main purpose of this study is to evaluate the efficacy and safety of this maintenance treatment approach. The primary outcome measure is the 1-year progression-free survival rate. Secondary outcome measures include conversion from partial response to complete response, duration of response, progression-free survival, overall survival, 1-year and 2-year overall survival rates, 2-year progression-free survival rate, minimal residual disease, complete molecular response, immune cell subsets, immune function markers, and adverse events.
Trial Details
NCT Number NCT07760610
Lead Sponsor The First Hospital of Jilin University
Conditions Diffuse Large B-Cell Lymphoma (DLBCL)
Enrollment 27 participants
Start Date 2026-09
Primary Completion 2028-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-12