MyCare Oncology Busulfan Assay Kit
Diagnostic TestThis is a sample collection study only. Patient treatment will not be determined by the outcome of the analytical test results.
Recruiting
NCT Number: NCT05711732
Busulfan Sample Collection Study
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States
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About this study
This protocol is sponsored by Saladax Biomedical, Inc (SBI). The protocol involves the use of sodium heparin plasma sample collected from human subjects receiving intravenous busulfan treatment for the use in the development of a diagnostic test for this drug. A subset of 10 enrolled subject samples will be tested on site using an automated immunoassay MyCareTM Oncology Busulfan Assay Kit manufactured by SBI.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Pediatric and adult female or male subjects;
- Current treatment with intravenous busulfan with documentation of diagnosed malignant hematologic or non-malignant disease condition requiring treatment;
- Adult participants must be capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study-specific procedures. Participants less than 18 years old must provide written assent with appropriate consent provided by legal guardian, who must be capable of understanding and providing informed consent, per Institutional Review Board (IRB) procedures, prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
- Unwilling or unable to follow protocol requirements or to give written informed consent;
- Patients receiving oral busulfan (e.g., Myleran®) treatment.
Treatment and study plan
Primary outcomes
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Method Comparison Study
Time frame: Sample 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 .
Sponsors and collaborators
Lead sponsor
Saladax Biomedical, Inc.
Industry
Registry information
Official study title
Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 3, 2023
- Registry last updated
- Jul 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.