NCT00563589Unknown不适用
A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2003年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- acute GVHD incidence and grading
研究概览
简要总结
There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling
排除标准
- •known allergy to mycophenolate mofetil
结局指标
主要结局
acute GVHD incidence and grading
时间窗: 100 Days
chronic GVHD incidence
时间窗: 3 Years
次要结局
- Mortality, GVHD-related and all cause(3 Years)
- Symptomatic side effects attributed to MMF(60 Days)
- Date of engraftment(Date of engraftment)
研究者
研究点 (1)
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