Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Pharmacokinetics parameter of melphalan
研究概览
简要总结
This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation
- •Patients age <19 years
- •Written Study Informed consent and/or assent from the patient, parent, or guardian
排除标准
- •Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
- •Patients in a medically critical condition such as severe infection or unstable vital signs
- •Any condition that would, in the Investigator's judgment, interfere with full participation in the study
- •Subjects who are pregnant or breast-feeding
- •Subjects with psychiatric conditions that may interfere with the study
- •Subjects who have a possibility of the disease getting worse as a treatment for clinical trials
研究组 & 干预措施
Cyclophosphamide
干预措施: Drug: Cyclophosphamide (Other)
结局指标
主要结局
Pharmacokinetics parameter of melphalan
时间窗: D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT)
Analysis: Area under the plasma concentration-time curve (AUC)
Pharmacokinetics parameter of melphalan
时间窗: Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)
Analysis: Maximum plasma drug concentration (Cmax)
Pharmacokinetics parameter of melphalan
时间窗: Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT)
Analysis: Maximum plasma drug concentration (Cmax)
次要结局
未报告次要终点
研究者
Hyoung Jin Kang
professor
Seoul National University Hospital