Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia
Conditions
Keywords
Hematopoietic stem cell transplantation with fludarabine based conditioning
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).
Interventions
DRUGFludarabine
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
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Evaluation of therapy related toxicity, significant adverse reaction | for 4 weeks |
Countries
South Korea
Contacts
Primary ContactHyoung Jin Kang, MD, PhD
Backup ContactJi Won Lee, MD
Outcome results
None listed