Lymphoma, Large B-Cell, Diffuse, Stage III Follicular Lymphoma
Conditions
Brief summary
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
Interventions
DRUGMetformin
metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
DRUGPlacebos
oral placebos as a maintenance therapy
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 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
| Measure | Time frame |
|---|---|
| Progress Free Survival | From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months |
Countries
China
Contacts
Primary ContactWeili Zhao Zhao
Backup ContactXing Fan
Outcome results
None listed