Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling
NCT ID: NCT01018446
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2008-12-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Busulfan, Pharmacokinetic
To develop a method to determine optimal dose of busulfan through pharmacokinetic study in hematopoietic stem cell transplantation.
Busulfan
First dose: busulfan (120 mg/m2 ivs once daily) (if age\<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Interventions
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Busulfan
First dose: busulfan (120 mg/m2 ivs once daily) (if age\<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Eligibility Criteria
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Inclusion Criteria
2. Age: no limits.
3. Performance status: ECOG 0-2.
4. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
5. Patients must lack any active viral infections or active fungal infection.
6. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
7. Patients (or one of parents if patients age \< 19) should sign informed consent.
Exclusion Criteria
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Korea National Enterprise for Clinical Trials
Principal Investigators
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Hyoung Jin Kang, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Daehangno, Jongno-gu, South Korea
Countries
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Other Identifiers
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SNUCH-SCT-0802
Identifier Type: -
Identifier Source: org_study_id