Allogeneic hematopoietic stem cell transplantation (HSCT) is widely used as a primary treatment for various malignant disorders (eg,
Conditions
Interventions
Bu was administered for two hours via IV infusion into patients every six hours for a total of 16 doses over four days.
Five-
fixed doses of Bu schedules were calculated based on actual body weight (ABW) as the preceding EMA labeling.
Basic Science
Pediatric received IV Bu
Sponsors
Faculty of Medicine, Mahidol University, Thailand
Faculty of Pharmacy,
Mahidol University,
Thailand
Siam University,
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion 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
Exclusion criteria: Patients previously undergoing HSCT were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Report the proportion of IV Bu within target AUC At 3 months after end of the Bu intervention each patients % target AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactThaksin Jansing
Unaffiliated
Outcome results
None listed