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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Metformin

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.