Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
Recruitment status was: Recruiting
Severe Aplastic Anemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation|
- Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients [ Time Frame: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose ] [ Designated as safety issue: Yes ]
- Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine [ Time Frame: 1, 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
- Evaluation of therapy related toxicity, significant adverse reaction [ Time Frame: for 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472055
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Daehangno, Jongno-gu, Korea, Republic of|
|Principal Investigator:||Hyoung Jin Kang, MD., PhD||Seoul National University Hospital|