A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients
NCT ID: NCT03600363
Last Updated: 2020-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
250 participants
INTERVENTIONAL
2018-09-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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metformin arm
Metformin
metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
control arm
Placebos
oral placebos as a maintenance therapy
Interventions
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Metformin
metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
Placebos
oral placebos as a maintenance therapy
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Deputy Director of Hematology Department
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Huijuan Zhong
Role: primary
Other Identifiers
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RJ-NHL-1805
Identifier Type: -
Identifier Source: org_study_id
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