A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Lymphoma, Large B-Cell, Diffuse, Stage III Follicular Lymphoma

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient age >14 years old; Pathological types include: diffuse large B lymphoma, and stage III follicular lymphoma; At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment; After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy; Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit; Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit; Serum creatinine not exceed 1.5mg/dl; Patients with high risk factors, including age > 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2. Sign informed consent file. Exclusion Criteria: Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy; Past medical history of any type of hematopoietic stem cell transplantation; Past medical history of lactic acidosis; Extreme weight loss failure, malnutrition or dehydration patients; Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age; Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent; 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; Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy); Any other serious complications occurred, depending on the outcome of the study; Before the intravenous pyelography or anterior angiography; Alcoholics; Deficiency of Vitamin B12, folic acid or iron.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin arm<br> | Drug: Metformin<br>* metformin (1.0g, bid) as a maintenance therapy in patients with complete remission<br>|
| Placebo Comparator: control arm<br> | Drug: Placebos<br>* oral placebos as a maintenance therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |