Clinical trial · Interventional
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
NCT01472055CI-TRIAL-00015424unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Chronic Leukemia | Chronic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Severe Aplastic Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine
- description
- Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
- interventionNames
- Drug: Fludarabine
Primary outcomes (1)
- measure
- Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
- timeFrame
- 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose
Secondary outcomes (3)
- measure
- Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.