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NOT YET RECRUITING
NCT07760610
PHASE4

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

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

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.

Official title: A Prospective, Single-Arm, Single-Center Clinical Study on the Maintenance Treatment of Young High-Risk Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Pomalidomide Combined With Rituximab.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-09

Completion Date

2029-07

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

Pomalidomide

Pomalidomide 4 mg will be administered orally once daily on Days 1 to 21 of each 28-day cycle for up to 24 months. Dose interruptions and reductions to 3 mg, 2 mg, or 1 mg once daily are permitted according to protocol-defined toxicity management.

DRUG

Rituximab

Rituximab 375 mg/m² will be administered by intravenous infusion on Day 1 every 8 weeks for up to 24 months.