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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01472055 |
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Date of registration:
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06/11/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
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Scientific title:
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Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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46 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01472055 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Hyoung Jin Kang, MD, PhD |
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Address:
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Telephone:
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+82 2 2072 0177 |
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Email:
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kanghj@snu.ac.kr |
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Affiliation:
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Name:
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Hyoung Jin Kang, MD, PhD |
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Address:
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Telephone:
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+82 2 2072 0177 |
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Email:
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kanghj@snu.ac.kr |
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Affiliation:
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Name:
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Hyoung Jin Kang, MD., PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
19 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Leukemia
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Severe Aplastic Anemia
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Chronic Leukemia
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Intervention(s)
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Drug: Fludarabine
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Primary Outcome(s)
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Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
[Time Frame: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose]
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Secondary Outcome(s)
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Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine
[Time Frame: 1, 3, 6 and 12 months after transplantation]
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Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
[Time Frame: 3 years]
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Evaluation of therapy related toxicity, significant adverse reaction
[Time Frame: for 4 weeks]
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Secondary ID(s)
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SNUCH-SCT-1101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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