Clinical trial · Interventional
A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients
A Prospective Randomized Controlled Phase II Clinical Trial of Metformin in the Maintenance Therapy of High Risk Diffuse Large B Lymphoma / Stage III Follicular Lymphoma Patients With Complete Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is to evaluate the therapeutic effect of metformin as a maintenance therapy in high risk patients with complete remission of diffuse large B lymphoma / stage III follicular lymphoma after chemotherapy in the initial R-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone, plus the monoclonal antibody rituximab) regimen
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Stage III Follicular Lymphoma | Follicular Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- metformin arm
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- control arm
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months
Secondary outcomes (1)
- measure
- Progress Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patient age \>14 years old; 2. Pathological types include: diffuse large B lymphoma, and stage III follicular lymphoma; 3. At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment; 4. After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy; 5. Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit; 6. Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit; 7. Serum creatinine not exceed 1.5mg/dl; 8. Patients with high risk factors, including age \> 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2. 9. Sign informed consent file. Exclusion Criteria: 1. Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy; 2. Past medical history of any type of hematopoietic stem cell transplantation; 3. Past medical history of lactic acidosis; 4. Extreme weight loss failure, malnutrition or dehydration patients; 5. Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age; 6. Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent; 7. Type 1.2 diabetes with ketoacidosis, liver function or renal insufficiency, pulmonary insufficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension or hypoxia; 8. Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy); 9. Any other serious complications occurred, depending on the outcome of the study; 10. Before the intravenous pyelography or anterior angiography; 11. Alcoholics; 12. Deficiency of Vitamin B12, folic acid or iron.
References
Publications (0)
Data not yet available