Diffuse Large B-Cell Lymphoma (DLBCL)Phase 4NCT07760610
Pomalidomide Plus Rituximab Maintenance in Young High-Risk Newly Diagnosed DLBCL After First-Line Response
A Phase 4 study testing Pomalidomide and Rituximab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by The First Hospital of Jilin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Pomalidomide and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
About this study
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.
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)
- Being tested
- Pomalidomide, Rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
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.
RituximabDrug
Rituximab 375 mg/m² will be administered by intravenous infusion on Day 1 every 8 weeks for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pomalidomide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Progression-Free Survival Rate
Measured: At 1 year after the start of maintenance treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760610
- Sponsor's protocol ID
- 26K151-002
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07760610
- Acronym / sponsor ID
- 26K151-002
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide Plus Rituximab Maintenance | Experimental | Drug: Pomalidomide, Drug: RituximabParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomalidomidePomalidomide 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 | Pomalidomide Plus Rituximab Maintenance |
| RituximabRituximab 375 mg/m² will be administered by intravenous infusion on Day 1 every 8 weeks for up to 24 months. | Drug | Pomalidomide Plus Rituximab Maintenance |
Primary outcome
1-Year Progression-Free Survival Rate
Time frame: At 1 year after the start of maintenance treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pomalidomide and Rituximab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Progression-Free Survival Rate (time frame: At 1 year after the start of maintenance treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.