NCT07760610Not yet recruitingPhase 4
Pomalidomide Plus Rituximab Maintenance in Young High-Risk Newly Diagnosed DLBCL After First-Line Response
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.
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- Sept 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07760610
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 27
- From Sept 2026 to the primary completion date, Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Current treatment with other investigational drugs.
- Participation in another clinical trial within 1 month before enrollment.
Other illness
- 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 hypertension or diabetes mellitus.
- Uncontrolled active infection or acute active infection.
- Contraindication or allergy to any study drug.
- 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.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.