Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- complete hemoglobin response rate
研究概览
简要总结
This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.
详细描述
Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed lymphoma
- •first autologous hematopoietic stem cell transplantation
- •hemoglobin level less than 100 g/L on day +15 post-transplant
- •written informed consent given by patient or his/her guardian if of minor age.
排除标准
- •HIV positive
- •Known allergy to recombinant human erythropoietin
- •Uncontrolled infection
研究组 & 干预措施
erythropoietin group
For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.
干预措施: erythropoietin (Drug)
iron supplementation
If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.
干预措施: iron supplementation (Drug)
结局指标
主要结局
complete hemoglobin response rate
时间窗: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant
次要结局
- proportion of participants with red blood cell transfusions(from day +15 to day +60 after autologous hematopoietic stem cell transplantation)
- proportion of participants with deep vein thrombosis(from day +15 to day +60 after autologous hematopoietic stem cell transplantation)
研究者
Jun Zhu
Chairman of Lymphoma Department
Peking University