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

NCT07760610 | Not Yet Recruiting Phase 4

• 1 other identifier: 26K151-002
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

• 1-Year Progression-Free Survival Rate

  At 1 year after the start of maintenance treatment

Study Arms (1)

Pomalidomide Plus Rituximab Maintenance

EXPERIMENTAL

Participants with newly diagnosed high-risk diffuse large B-cell lymphoma who achieve at least a partial response after first-line treatment will receive maintenance therapy with pomalidomide plus rituximab for up to 24 months.

Drug: Pomalidomide; Drug: Rituximab

Interventions

Pomalidomide DRUG

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.

Pomalidomide Plus Rituximab Maintenance

Rituximab DRUG

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

Pomalidomide Plus Rituximab Maintenance

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
• Adequate bone marrow hematopoietic function, defined as absolute neutrophil count ≥1.5 × 10\^9/L, with granulocyte colony-stimulating factor support allowed; platelet count ≥75 × 10\^9/L, with platelet transfusion allowed to reach this minimum platelet count; and hemoglobin ≥8.0 g/dL, with prior red blood cell transfusion or recombinant human erythropoietin allowed. If abnormal peripheral blood counts are caused by lymphoma involvement of the bone marrow or spleen, eligibility may be determined at the investigator's discretion.
• Adequate major organ function, defined as total serum bilirubin ≤2.0 × upper limit of normal (ULN), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, and creatinine clearance \>30 mL/min. For participants with hepatic involvement by lymphoma, eligibility may be determined at the investigator's discretion.
• Expected survival of ≥3 months as judged by the investigator.
• Ability to understand the study and willingness to provide written informed consent.
• Female participants must use effective contraception, must not be pregnant, and must agree n

You may not qualify if:

• 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.
• Uncontrolled hypertension or diabetes mellitus.
• Uncontrolled active infection or acute active infection.
• Contraindication or allergy to any study drug.
• Pregnant or breastfeeding women.
• Any severe physical or psychiatric illness that, in the opinion of the protocol or the investigator, may interfere with participation in this clinical study; or any substance abuse, medical, psychological, or social condition that may interfere with study participation or assessment of study results.
• Current treatment with other investigational drugs.
• Participation in another clinical trial within 1 month before enrollment.
• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

pomalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08