Children's Hospital of Philadelphia
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.
Busulfan is a drug used in conditioning regimens for bone marrow transplantation. Busulfan levels outside the desired range can cause excessive side effects or failure of bone marrow engraftment. The initial dose of busulfan is currently scaled to body weight; on subsequent days the dose may be adjusted to achieve busulfan levels in a therapeutic range. However, only half of children receiving a busulfan dose scaled to body weight achieve therapeutic blood levels after the first dose. We performed computer simulations of alternative dosing methods for infants and children, and identified that…
Inclusion Criteria: 1. Subject age: ≤21 years 2. Body Surface Area (BSA): 1. Group A: BSA ≥0.5 m2 2. Group B: BSA \<0.5 m2 3. Planned for once-daily busulfan-containing conditioning regimen pre-bone marrow transplant 4. Scheduled to have TDM after the first dose of busulfan 5. Diagnosis: both benign and malignant conditions are eligible Exclusion Criteria: 1\. At the time of enrollment, patients may not receive medications that significantly alter busulfan clearance, as specified below. a. If patients had received the drugs listed below prior to enrollment, the following washout per…
Busulfan is a cell cycle non-specific alkylating agent which is approved by the Food and Drug Administration (FDA) and is commercially available.
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