NCT00578045撤回1 期
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The researchers on this study want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.
研究概览
简要总结
The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.
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
- 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 with advanced hematological malignancies who have failed at least two lines of therapy.
- •Karnofsky performance score > 60, unless due to disease and then >
- •Age > 18 years.
- •An expected survival of > 3 months.
- •Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study.
- •Cord blood must have negative serology for HIV.
- •Release of cord blood.
- •The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight.
排除标准
- •Liver function: total bilirubin > 2x ULN or AST/ALT > 3x ULN.
- •Creatinine > 3.0 mg/dL.
结局指标
主要结局
The researchers on this study want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.
时间窗: 12 months
次要结局
- The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment.(12 months)
研究者
研究点 (2)
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