Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Ministry of Food and Drug Safety, Korea
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

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