Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
N/A
19 Years
Both
Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia
Trial Information
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
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).
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Outcome Time Frame:
0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose
Safety Issue:
Yes
Principal Investigator
Hyoung Jin Kang, MD., PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
SNUCH-SCT-1101
NCT ID:
NCT01472055
Start Date:
October 2011
Completion Date:
September 2014
Related Keywords:
- Acute Leukemia
- Chronic Leukemia
- Severe Aplastic Anemia
- Hematopoietic stem cell transplantation with fludarabine based conditioning
- Anemia
- Anemia, Aplastic
- Leukemia
- Chronic Disease
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