ACTRN12609000173291招募中2 期
A Phase II Study of the Impact of Two Different Schedules of Thymoglobulin on the Incidence of Extensive Chronic Graft Versus Host Disease (GVHD) in Undergoing Unrelated Donor or Mismatched Related Donor Stem Cell Transplantation for Haematological Malignancy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.age > 18 years
- •2.undergoing an unrelated or mismatched related peripheral blood stem cell (PBSC) allograft
- •3.no contra-indication to receiving Thymoglobulin
- •4.life expectancy >3 months
- •5.absence of active invasive fungal infection at the time of transplant
- •6.myeloablative conditioning (including cy/TBI, VP16/TBI fludarabine-melphalan >120mg/m2, fludarabine-busulphan at a dose at least equivalent to 3.2mg/kg intravenous (IV) per day for 4 days and by-cy. IV busulphan will be used, given as a single daily dose of 3.2mg/kg at a rate of 80mg/hr. Monitoring, if available, will be done to conform with local guidelines
排除标准
- •1.active invasive fungal infection at the time of transplant
- •2.contra-indication to receiving Thymoglobulin
- •3.Pregnancy
研究者
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