NCT00144729已完成1 期
Conditioning Regimens for Patients With Severe Aplastic Anemia Transplanted With Marrow From an Unrelated Donor
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Sustained engraftment; survival
研究概览
简要总结
A single arm dose optimization study in which all patients are given a fixed dose of Cytoxan (4 x 50 mg/kg) plus ATG (3 x 30 mg/kg) and the TBI dose starting at 3 x 200 cGy is escalated or de-escalated dependent upon engraftment and toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life-threatening marrow failure of nonmalignant etiology;
- •failure to respond to the best available immunosuppressive treatment;
- •lack of a HLA-identical family member
排除标准
- •Severe disease other than aplastic anemia that would severly limit the probability of survival during the graft procedure;
- •HIV seropositive patients;
- •clonal abnormalities or myelodysplastic syndrome;
结局指标
主要结局
Sustained engraftment; survival
次要结局
- Acute and chronic GVHD
研究者
研究点 (2)
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