NCT03600363Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Sign informed consent file.
排除标准
- •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.
研究组 & 干预措施
metformin arm
Experimental
干预措施: Metformin (Drug)
control arm
Placebo Comparator
干预措施: Placebos (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months
次要结局
- Progress Free Survival(From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months)
研究者
Zhao Weili
Deputy Director of Hematology Department
Ruijin Hospital
研究点 (1)
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