NCT02483325已完成2 期
Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- rates progression free survival 2 years
研究概览
简要总结
Determine the efficiency of a myéloablative conditioning associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in preparation for a allogenic transplant family or not family compatible HLA.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Busulfan with adapted doses
Other
Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)
干预措施: Allogeneic transplant conditioning (Drug)
结局指标
主要结局
rates progression free survival 2 years
时间窗: Time to progression or death
次要结局
- Plasmatic concentration of Busulfan(Time from inclusion until Day -1 before allogenic transplantation)
研究者
研究点 (1)
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