Busulfan Sample Collection Study

This study is collecting samples from people who are currently receiving intravenous (IV) busulfan (Busulfex®) treatment. Busulfan is a drug used before stem cell transplants for certain blood cancers or other non-cancerous conditions. The purpose is to develop a diagnostic test called the MyCare™ Oncology Busulfan Assay Kit. This test aims to help doctors personalize busulfan dosing, as the drug's effects can vary greatly among individuals, potentially leading to side effects or less effective treatment. Your treatment will not be changed based on the results of this test. We are looking for 150 pediatric and adult participants.

Study design
This is an observational study involving 150 participants. It is designed to compare different methods for detecting busulfan levels.
What's involved
Sample collection will take place over one year. The specific procedures for sample collection are not detailed in the record.
Compensation
Not stated in the trial record.
Follow-up
Samples will be analyzed monthly over a one-year period after collection.

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NCT05711732

Busulfan Sample Collection Study

Recruiting
Not specifiedAll AgesObservational
Saladax Biomedical, Inc.
~150 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:MyCare Oncology Busulfan Assay Kit

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Method Comparison Study
Measured over Sample collection to take place over 1 year. Samples to be analyzed monthly.
Subjects Treated With Busulfan
3 sites across 3 states
Illinois1
New Jersey1
Texas1

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  • Method Comparison StudySample collection to take place over 1 year. Samples to be analyzed monthly.

    The samples being collected according to the protocol, SBI-BSI-001, will be used to compare the quantitate determination of BSF in patient samples based on the immunoassay vs. LC-MS/MS methods .