Acute Leukemia Clinical Trial
Official title:
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 19 Years |
Eligibility |
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 ? upper limit of normal; ALT < 3 ? upper limit of normal. - Kidney: creatinine < 2 ? 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Daehangno, Jongno-gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Ministry of Food and Drug Safety, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients | 3 years | No | |
Secondary | Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine | 1, 3, 6 and 12 months after transplantation | No | |
Secondary | Evaluation of therapy related toxicity, significant adverse reaction | for 4 weeks | No |
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