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.
Age ≥18 years and <60 years, male or female.
Histologically confirmed newly diagnosed diffuse large B-cell lymphoma (DLBCL), with at least a partial response (PR) after first-line therapy.
Age-adjusted International Prognostic Index (aaIPI) >1 at initial diagnosis.
Ann Arbor stage II-IV disease at initial diagnosis.
Presence of another active malignancy that is untreated or currently being treated.
History of severe venous thromboembolism (VTE) or cerebral infarction before treatment.
Active hepatitis B or hepatitis C infection, or human immunodeficiency virus (HIV) seropositivity.
Uncontrolled or severe cardiovascular disease, including myocardial infarction within 3 months before enrollment, unstable coronary artery disease, uncontrolled chronic congestive heart failure, New York Heart Association (NYHA) class III-IV heart failure, or clinically significant pericardial disease.
Single group
Pomalidomide
DrugPomalidomide 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.
Rituximab
DrugRituximab 375 mg/m² will be administered by intravenous infusion on Day 1 every 8 weeks for up to 24 months.
1-Year Progression-Free Survival Rate
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