Population Pharmacokinetics of the Nucleoside Analogues Clofarabine and Fludarabine in Pediatric Patients Undergoing Hematopoietic Cell Transplantation (alloHCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of fludarabine and clofarabine dual therapy for HCT in pediatric patients.
研究概览
简要总结
Fludarabine and clofarabine are chemotherapy drugs used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of clofarabine and fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that clinical and individual factors cause changes in clofarabine and fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.
详细描述
Fludarabine and clofarabine are nucleoside analogs with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation (alloHCT) to promote stem cell engraftment.
This is a single-center, prospective, non-interventional pharmacokinetic (PK) study investigating the clinical pharmacology of combination nucleoside analogue therapy in 24 children undergoing alloHCT at University of California, San Francisco Benioff Children's Hospital.
Patients would receive clofarabine and fludarabine regardless of whether or not they decide to consent to PK sampling.
Clofarabine and fludarabine doses will not be adjusted based on PK data.
The investigators will apply the combination of a limited sampling strategy and population PK methodologies to determine specific factors influencing clofarabine and fludarabine exposure in pediatric alloHCT recipients and identify exposure-response relationships.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 0-17 years of age
- •Undergoing alloHCT for the treatment of malignant or nonmalignant disorder
- •Receiving clofarabine and fludarabine-based preparative regimen
排除标准
- •Any child 7-17 years of age unwilling to provide assent
研究组 & 干预措施
Pediatric Bone Marrow Transplantation Recipients
Children undergoing alloHCT at UCSF Benioff Children's Hospital.
干预措施: Clofarabine (Drug)
Pediatric Bone Marrow Transplantation Recipients
Children undergoing alloHCT at UCSF Benioff Children's Hospital.
干预措施: Fludarabine Injection (Drug)
结局指标
主要结局
Analysis of the Area under the Plasma Concentration versus Time Curve (AUC) of fludarabine and clofarabine dual therapy for HCT in pediatric patients.
时间窗: 24hours post start of infusion
次要结局
- Evaluate the event free survival according to the AUC of fludarabine and clofarabine dual therapy(1 year post transplant)