A single-arm prospective Phase II clinical trial of metformin in the maintenance of non-Hodgkin's lymphoma patients

A single-arm prospective Phase II clinical trial of metformin in the maintenance therapy of diffuse large B lymphoma / stage III follicular lymphoma patients with complete remission

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIN-17012130

Enrollment

Unknown

Registered

2017-07-25

Start date

2013-04-01

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-Hodgkin's lymphoma

Interventions

experimental group:Metformin involved in maintenance therapy

control group:Metformin not involved in maintenance therapy

Eligibility

Sex/Gender

All

Age

19 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patient age> 18 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. SGOT and 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. Sign informed consent file.

Exclusion criteria

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;	—

Countries

China

Contacts

Public ContactWeili Zhao

Shanghai Jiaotong University School of Medicine, Ruijin Hospital

zhao.weili@yahoo.com+86 13512112076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026