Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
研究概览
简要总结
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
详细描述
Fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. However, no pharmacokinetic study has thus far been conducted in pediatric patients. Fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. Pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients.
Through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics.
Through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free 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
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conditioning regimen including fludarabine
- •Age: < 19 years old
- •Functional class: ECOG 0-2
- •No loss of function of major organs. Criteria may be individualized.
- •Heart: shortening fraction > 30%, ejection fraction > 45%.
- •Liver: total bilirubin < 2 ⅹ upper limit of normal; ALT < 3 ⅹ upper limit of normal.
- •Kidney: creatinine < 2 ⅹ normal or a creatinine clearance (GFR) > 60 ml/min/1.73m
- •No active viral or fungal infection
- •Appropriate hematopoietic stem cell donor
- •Informed consent from patients' parents
排除标准
- •Pregnant or breast feeding
- •Disease progression due to clinical test
- •Psychiatric disease may interfere with clinical test
- •Whether attending physician consider the patient inappropriate for study enrollment
研究组 & 干预措施
Fludarabine
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
干预措施: Fludarabine (Drug)
结局指标
主要结局
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
时间窗: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose
次要结局
- Evaluation of therapy related toxicity, significant adverse reaction(for 4 weeks)
- Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients(3 years)
- Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine(1, 3, 6 and 12 months after transplantation)