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

Phase 2

• Conditions: Lymphoma, Large B-Cell, Diffuse; Stage III Follicular Lymphoma
• Interventions: Drug: Placebos; Drug: Metformin

• Registration Number: NCT03600363
• Lead Sponsor: Ruijin Hospital

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Study Start: 2018-09-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2021-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	Placebos	-
metformin arm	Metformin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Progress Free Survival	From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China