Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

Phase 2UnknownNCT01472055

Seoul National University Hospital46 enrolled

Overview

The purpose of this study is to 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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Leukemia Chronic Leukemia Severe Aplastic Anemia

Interventions

FludarabineDRUG

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

Eligibility

Sex: ALLMax age: 19 Years

Medical Language ↔ Plain English

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 (1)

Seoul National University Hospital

Seoul, Daehangno, Jongno-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients

Time frame: 3 years

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

Time frame: 1, 3, 6 and 12 months after transplantation

Evaluation of therapy related toxicity, significant adverse reaction

Time frame: for 4 weeks

Central Contacts

Hyoung Jin Kang, MD, PhD

CONTACT

+82 2 2072 0177 kanghj@snu.ac.kr

Ji Won Lee, MD

CONTACT

+82 2 2072 3452 agnesjw@hanmail.net

Data from ClinicalTrials.gov

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