NCT04937634招募中1 期
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Melphalan concentration
研究概览
简要总结
This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT).
- •Age is below 19 at the time of diagnosis of a disease which is HSCT indication
- •Written Study Informed consent and/or assent from the patient, parent, or guardian
排除标准
- •Female patients who are pregnant or breast feeding
- •Study treatment would deteriorate patient's disease.
- •The patient may have problems with study participation due to a psychotic disorder.
- •Any condition that would, in the Investigator's judgement, interfere with participation in the study
研究组 & 干预措施
Melphalan
Experimental
干预措施: Melphalan (Drug)
结局指标
主要结局
Melphalan concentration
时间窗: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
Analysis: Half lite (T1/2)
次要结局
未报告次要终点
研究者
研究点 (1)
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