Busulfan Dosing for Bone Marrow Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this pilot study is to determine if scaling the first busulfan dose to Body Surface Area (BSA) in children with a BSA ≥0.5 m2 and using a BSA-banded dosing table for infants (BSA \<0.5 m2) increases the fraction of patients achieving a therapeutic drug exposure after the first dose.
Are You a Good Fit for This Trial?
This trial is for children who need a bone marrow transplant and will be receiving busulfan. It includes both infants (with smaller body size) and older children, as long as their body surface area can be measured.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Busulfan
Trial Overview
The study is testing if adjusting the first dose of busulfan based on each child's body size helps more kids reach the right drug level after one dose. Different dosing methods are used for infants versus bigger children.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receiving once daily busulfan in their pre-transplant conditioning regimen will have the first busulfan dose scaled to their BSA instead of their body weight. On day 1, patients with BSA \<0.5 m2 the dose will be selected from a BSA-banded dosing table. Subsequent doses of busulfan on days 2-4 will be guided by standard care, including therapeutic drug monitoring (TDM) to achieve an AUC within the therapeutic range.
Patients receiving once daily busulfan in their pre-transplant conditioning regimen will have the first busulfan dose scaled to their BSA instead of their body weight. On day 1, patients with BSA ≥0.5 m2 will receive 100 mg/m2 Busulfan. Subsequent doses of busulfan on days 2-4 will be guided by standard care, including therapeutic drug monitoring (TDM) to achieve an AUC within the therapeutic range.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
Alex's Lemonade Stand Foundation
Industry Sponsor
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