NCT01589549Unknown2 期
A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation
R.P.Herrmann2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Survival at one year after onset of graft versus host disease
研究概览
简要总结
A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.
It is hypothesised that mesenchymal stromal cell therapy will be superior
详细描述
Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
- •Age 18-55 years
- •Must be receiving a calcineurin inhibitor
排除标准
- •Failure to sign informed consent
- •Corticosteroid therapy for 72 hours or greater
- •ECOG score equal to or greater than 3
结局指标
主要结局
Survival at one year after onset of graft versus host disease
时间窗: One year
次要结局
- Time to treatment failure, requiring salvage therapy(28 days)
- Response at 14 days after commencement of treatment for acute graft versus host disease(14 days)
- Incidence of severe infection(One year)
- Response at 28 days after commencement of treatment of acute graft versus host disease(28 days)
- Disease free survival at one year(One year)
研究者
R.P.Herrmann
Director, Cell and Tissue Therapies, Royal Perth Hospital
Royal Perth Hospital
研究点 (2)
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