Brief Title
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
Official Title
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Secondary Outcome
Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
Condition
Acute Leukemia
Intervention
Fludarabine
Study Arms / Comparison Groups
Fludarabine
Description: Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
46
Start Date
October 2011
Completion Date
September 2014
Primary Completion Date
September 2014
Eligibility Criteria
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 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
Gender
All
Ages
N/A - 19 Years
Accepts Healthy Volunteers
No
Contacts
Hyoung Jin Kang, MD., PhD, +82 2 2072 0177, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01472055
Organization ID
SNUCH-SCT-1101
Study Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
Study Sponsor
Hyoung Jin Kang, MD., PhD, Principal Investigator, Seoul National University Hospital
Verification Date
August 2014