Status:
UNKNOWN
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Food and Drug Safety, Korea
Conditions:
Acute Leukemia
Chronic Leukemia
Eligibility:
All Genders
Up to 19 years
Phase:
PHASE2
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. Flud...
Eligibility Criteria
Inclusion
- Conditioning regimen including fludarabine
- Age: \< 19 years old
- Functional class: ECOG 0-2
- 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.
- No active viral or fungal infection
- Appropriate hematopoietic stem cell donor
- Informed consent from patients' parents
Exclusion
- Pregnant or breast feeding
- Disease progression due to clinical test
- Psychiatric disease may interfere with clinical test
- Whether attending physician consider the patient inappropriate for study enrollment
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01472055
Start Date
October 1 2011
End Date
September 1 2014
Last Update
August 20 2014
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Daehangno, Jongno-gu, South Korea