Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
NCT ID: NCT01472055
Last Updated: 2014-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
46 participants
INTERVENTIONAL
2011-10-31
2014-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fludarabine
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Fludarabine
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
Interventions
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Fludarabine
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 Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Ministry of Food and Drug Safety, Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Principal Investigators
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Hyoung Jin Kang, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Daehangno, Jongno-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SNUCH-SCT-1101
Identifier Type: -
Identifier Source: org_study_id
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