Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Phase 2

• Conditions: Acute Leukemia; Chronic Leukemia; Severe Aplastic Anemia
• Interventions: Drug: Fludarabine

• Registration Number: NCT01472055
• Lead Sponsor: Seoul National University Hospital

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-06
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Conditioning regimen including fludarabine

2. Age: < 19 years old

3. Functional class: ECOG 0-2

4. No loss of function of major organs. Criteria may be individualized.

   • Heart: shortening fraction > 30%, ejection fraction > 45%.
   • Liver: total bilirubin < 2 ⅹ upper limit of normal; ALT < 3 ⅹ upper limit of normal.
   • Kidney: creatinine < 2 ⅹ normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.

5. No active viral or fungal infection

6. Appropriate hematopoietic stem cell donor

7. Informed consent from patients' parents

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Exclusion Criteria

1. Pregnant or breast feeding
2. Disease progression due to clinical test
3. Psychiatric disease may interfere with clinical test
4. Whether attending physician consider the patient inappropriate for study enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fludarabine	Fludarabine	Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients

Primary Outcome Measures

Name	Time	Method
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients	0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose

Secondary Outcome Measures

Name	Time	Method
Evaluation of therapy related toxicity, significant adverse reaction	for 4 weeks
Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients	3 years
Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine	1, 3, 6 and 12 months after transplantation

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Daehangno, Jongno-gu, Korea, Republic of