NCT01472055

Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

Detailed description

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).

Conditions

• Acute Leukemia
• Chronic Leukemia
• Severe Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Fludarabine	1. Fludarabine 40 mg/m\^2 once a day intravenous administration over 30 min 2. Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr 3. Population pharmacokinetics analysis 4. Comparative analysis of population pharmacokinetics in pediatric and adult patients 5. Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-11-16
• Last updated: 2014-08-20

Locations

1 site across 1 country: South Korea