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Busulfan Sample Collection Study
Sponsor: Saladax Biomedical, Inc.
Summary
Busulfan (Busulfex®) is an alkylating drug used as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. Busulfan has wide inter- and intra-patient pharmacokinetic variability resulting in variable exposure leading to increased risk of toxicities or sub-optimal treatment outcomes. Therapeutic drug monitoring of busulfan using patient plasma samples would benefit clinicians by providing the ability to personalize the dose to achieve a target busulfan exposure.
Official title: Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2024-02-08
Completion Date
2026-01-31
Last Updated
2025-04-03
Healthy Volunteers
No
Conditions
Interventions
MyCare Oncology Busulfan Assay Kit
This is a sample collection study only. Patient treatment will not be determined by the outcome of the analytical test results.
Locations (2)
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States