TCTR20190528003
Completed
未知
A Pilot Therapeutic Drug Monitoring of Intravenous Busulfan in Thai Children Undergoing Hematopoietic Stem Cell Transplantation
Faculty of Medicine, Mahidol University, Thailand0 sites10 target enrollmentMay 28, 2019
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Allogeneic hematopoietic stem cell transplantation (HSCT) is widely used as a primary treatment for various malignant disorders (eg,
- Sponsor
- Faculty of Medicine, Mahidol University, Thailand
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pediatric patients undergoing allogeneic HSCT were enrolled in this study.
- •\-The age range was from one year after birth to less than 18 years.
- •\-The eligibility criteria are the patients must have adequate organ system function (cardiac, pulmonary, renal, and hepatic systems). That are, serum creatinine \< 2 times of the upper limit of normal (ULN) values, serum total bilirubin \< 1\.5 times of the ULN, and AST and ALT \< 3 times of the ULN.
- •\-Histocompatibility was determined by DNA typing with intermediate\- or high\-resolution in class I (A, B, C) and II (DR, DQ) for 10 loci, using standard technique.
- •\-The protocol and informed consent forms were approved by institutional review boards, Mahidol University, with full compliance of international Guidelines for Human Research Protection, such as Declaration of Helsinki, The Belmont Report, CIOMS Guidelines and the International Conference on Harmonization in Good Clinical Practice (ICG\-GCP).
- •\-Written consent or assent in children were informed before they were enrolled in this study.
Exclusion Criteria
- •Patients previously undergoing HSCT were excluded.
Outcomes
Primary Outcomes
Not specified
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