NCT01821781进行中（未招募）2 期
A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with donor engraftment
研究概览
简要总结
This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •</= 28 years of age
- •Performance status >/= 40
- •DLCO >/= 40%
- •LVEF >/=40% or LVSF >/=26%
- •Serum creatinine < 2x ULN
- •Liver enzymes </= 5x ULN
- •Negative pregnancy test
- •Suitably matched donor (6/6 matched sib UCB, 8/8 matched sib BM or PBSC, 5-6/6 matched unrelated UCB, 7-8/8 matched unrelated BM, double cord)
排除标准
- •Known diagnosis of HIV I/II
- •Pregnant or breastfeeding
- •Uncontrolled invasive fungal or bacterial infections within 1 month prior to starting alemtuzumab
- •Uncontrolled viral infection within 1 week prior to starting alemtuzumab
研究组 & 干预措施
Preparative
Experimental
干预措施: Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan (Drug)
结局指标
主要结局
Number of participants with donor engraftment
时间窗: 1 year post transplant
次要结局
- Number of patient with acute GVHD(180 days post transplant)
- Major Transplant Related Toxicities(1 years post transplant)
- Time to neutrophil recovery(within 100 days post transplant)
- Number of participants with infectious complications(2 years post transplant)
- Time to immune reconstitution(2 years post transplant)
- Overall survival(2 years post transplant)
- Time to platelet recovery(within 100 days post transplant)
- Number of patients with chronic GVHD(2 years post transplant)
- Disease free survival(2 years post transplant)
研究者
研究点 (1)
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