Busulfan Sample Collection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyCare Oncology Busulfan Assay Kit.
- Who it may be relevant to
- Registry conditions: Subjects Treated With Busulfan. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test 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.
Primary outcome measures
- Method Comparison Study [Time frame: Sample collection to take place over 1 year. Samples to be analyzed monthly.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
- Rutgers Cancer Institute — New Brunswick
- The University of Texas MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT05711732 · SBI-BSF-001