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Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Leukemia; Chronic Leukemia; Severe Aplastic Anemia

Intervention: Fludarabine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Hyoung Jin Kang, MD., PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Hyoung Jin Kang, MD, PhD, Phone: +82 2 2072 0177, Email: kanghj@snu.ac.kr

Summary

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

Clinical Details

Official title: Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine

Evaluation of therapy related toxicity, significant adverse reaction

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).

Eligibility

Minimum age: N/A. Maximum age: 19 Years. Gender(s): Both.

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

Locations and Contacts

Hyoung Jin Kang, MD, PhD, Phone: +82 2 2072 0177, Email: kanghj@snu.ac.kr

Seoul National University Hospital, Seoul, Daehangno, Jongno-gu, Korea, Republic of; Recruiting
Hyoung Jin Kang, MD, PhD, Phone: +82 2 2072 0177, Email: kanghj@snu.ac.kr
Ji Won Lee, MD, Phone: +82 2 2072 3452, Email: agnesjw@hanmail.net
Hyoung Jin Kang, MD, PhD, Principal Investigator
Additional Information

Starting date: October 2011
Last updated: August 18, 2014

Page last updated: August 20, 2015

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