Acute Leukemia Clinical Trial
Official title:
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
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).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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