Clinical trial NCT03600363: A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Stage III Follicular Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
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:
measure: Progress Free Survival
timeFrame: From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References: