NCT02011022已完成不适用
Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Acute Lymphoblastic Leukemia: Significant Impact Factors and Establishment of a Clinically Relevant Model
The Children's Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2009年5月最近更新:
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
- 发起方
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- elimination delay
研究概览
简要总结
* The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
详细描述
- Methotrexate (MTX) is one of the critical components for treating all forms of acute lymphoblastic leukemia (ALL), which is the most common pediatric cancer. Unfortunately, high dose MTX has several undesirable side effects and MTX toxicity vastly differs from patient to patient.
- The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
- The final model was validated using nonparametric bootstrap analysis. Body surface area (BSA), pre-hydration, baseline serum creatinine and 24 h creatinine clearance rate were statistically significant covariates for distributional volume (V) and renal clearance (CL). Herein, is the first report of analysis of the importance of a series of patient factors on pharmacokinetics of MTX by one-compartment model. Using these data, we have established an efficient population pharmacokinetic model for MTX, which can be used to predict safe clinical application of MTX especially in children with ALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old
排除标准
- •Non lymphoblastic malignancies or older than 18 years
研究组 & 干预措施
3g group
Experimental
The dose of MTX is 3 g/m2
干预措施: 3g MTX (Drug)
5g group
Experimental
The dose of MTX is 5g/m2
干预措施: 5g MTX (Drug)
结局指标
主要结局
elimination delay
时间窗: 3 days
The serum MTX is higher than 1umol/L in 48 hours or 0.1umol/L in 96 hours
次要结局
未报告次要终点
研究者
Weiqun Xu
Doctor
The Children's Hospital of Zhejiang University School of Medicine
研究点 (1)
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