Pomalidomide Plus Rituximab Maintenance in Young High-Risk Newly Diagnosed DLBCL After First-Line… (NCT07760610) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Pomalidomide Plus Rituximab Maintenance in Young High-Risk Newly Diagnosed DLBCL After First-Line Response
27 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-Year Progression-Free Survival Rate
Timeframe: At 1 year after the start of maintenance treatment
. 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.
Exclusion criteria
. 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.