NCT00582894已完成不适用
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Transplant Related Mortality (TRM)
研究概览
简要总结
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases
详细描述
Primary Endpoints:
- Engraftment of donor cells
- Regimen related toxicities
Secondary Endpoints:
- Disease-free survival
- Overall survival
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status 0-2
- •Ejection fraction > 30%
- •AST/ALT and bilirubin not > 4 times normal
- •Creatinine clearance greater than 70 ml/min.
- •FEV1 greater than 1.0 and diffusion capacity greater than 40%
- •Age 18-75 years
- •Patients must be at high risk for conventional regimen related toxicity
- •Malignant hematologic disease that would otherwise be considered treatable with ASCT
排除标准
- •Does not meet the above Inclusion criteria
研究组 & 干预措施
A
Other
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
干预措施: Busulfex, Fludarabine, ALemtuzumab (Drug)
结局指标
主要结局
Number of Participants Experiencing Transplant Related Mortality (TRM)
时间窗: At Day 100 post trans-plant
Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
时间窗: At time of study termination
次要结局
- Number of Participants Relapse-Free(100 days post-transplant)
- Number of Participants Overall Survival as a Function of Time.(100 days post transplant)
研究者
研究点 (1)
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