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

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Metformin

Placebos

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patient age >14 years old;
Pathological types include: diffuse large B lymphoma, and stage III follicular lymphoma;
At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment;
After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy;
Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit;
Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit;
Serum creatinine not exceed 1.5mg/dl;
Patients with high risk factors, including age > 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2.
Sign informed consent file.

Exclusion Criteria:

Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy;
Past medical history of any type of hematopoietic stem cell transplantation;
Past medical history of lactic acidosis;
Extreme weight loss failure, malnutrition or dehydration patients;
Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age;
Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent;
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;
Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy);
Any other serious complications occurred, depending on the outcome of the study;
Before the intravenous pyelography or anterior angiography;
Alcoholics;
Deficiency of Vitamin B12, folic acid or iron.

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metformin arm

control arm

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progress Free Survival

Full Information

NCT ID

NCT03600363

First Posted

July 17, 2018

Last Updated

March 9, 2020

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03600363

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin arm

Arm Type

Experimental

Arm Title

control arm

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

metformin (1.0g, bid) as a maintenance therapy in patients with complete remission

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

oral placebos as a maintenance therapy

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

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 Measure Information:

Title

Progress Free Survival

Time Frame

From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patient age >14 years old; Pathological types include: diffuse large B lymphoma, and stage III follicular lymphoma; At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment; After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy; Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit; Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit; Serum creatinine not exceed 1.5mg/dl; Patients with high risk factors, including age > 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2. Sign informed consent file. Exclusion Criteria: Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy; Past medical history of any type of hematopoietic stem cell transplantation; Past medical history of lactic acidosis; Extreme weight loss failure, malnutrition or dehydration patients; Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age; Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent; 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; Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy); Any other serious complications occurred, depending on the outcome of the study; Before the intravenous pyelography or anterior angiography; Alcoholics; Deficiency of Vitamin B12, folic acid or iron.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Zhao Zhao

Phone

64370045

Ext

610707

zhao.weili@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xing Fan

Phone

64370045

Ext

610707

fx-86@163.com

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huijuan Zhong

12. IPD Sharing Statement

Learn more about this trial

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

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