Therapeutic Drug Monitoring of Intravenous Busulfan in Thai Children Undergoing Hematopoietic Stem Cell Transplantation: A Pilot Study

Not Applicable

Completed

• Conditions: Allogeneic hematopoietic stem cell transplantation (HSCT) is widely used as a primary treatment for various malignant disorders (eg, acute myeloid leukemia) and non- malignant disorders (eg, thalassemi; busulfan; therapeutic drug monitoring; area under the curve; transplantation; children

• Registration Number: TCTR20190528003
• Lead Sponsor: Faculty of Medicine, Mahidol University, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-04-30
• Study Start: 2019-05-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Report the proportion of IV Bu within target AUC At 3 months after end of the Bu intervention each patients % target AUC

Secondary Outcome Measures

Name	Time	Method
Report the PK parameters and early clinical outcomes in the first three months after HSCT. At 3 months after end of the Bu intervention each patients % of early clinical outcomes