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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03600363
• Other study ID #: RJ-NHL-1805
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: Weili Zhao Zhao
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Metformin
metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
• Placebos
oral placebos as a maintenance therapy

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progress Free Survival		From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months