Collecting samples from patients treated with busulfan
Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
This study is trying to collect blood samples from patients getting busulfan treatment to see if they can create a test that helps tailor the right dose for each person before their stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Saladax Biomedical, Inc. Industry-sponsored |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05711732 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients receiving intravenous busulfan, an alkylating drug used before hematopoietic stem cell transplantation. It aims to collect sodium heparin plasma samples to develop a diagnostic test that can help personalize busulfan dosing based on individual pharmacokinetics. A subset of samples will be tested using the MyCare Oncology Busulfan Assay Kit to assess drug exposure and optimize treatment outcomes. The study is sponsored by Saladax Biomedical, Inc.
Who should consider this trial
Good fit: Ideal candidates include pediatric and adult patients currently receiving intravenous busulfan for malignant or non-malignant diseases.
Not a fit: Patients receiving oral busulfan or those unable to comply with protocol requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective dosing of busulfan, reducing the risk of toxicities and improving treatment outcomes for patients.
How similar studies have performed: While this approach is focused on developing a specific diagnostic test, similar studies in therapeutic drug monitoring have shown promise in optimizing treatment regimens.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pediatric and adult female or male subjects; 2. Current treatment with intravenous busulfan with documentation of diagnosed malignant hematologic or non-malignant disease condition requiring treatment; 3. 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: 1. Unwilling or unable to follow protocol requirements or to give written informed consent; 2. Patients receiving oral busulfan (e.g., Myleran®) treatment.
Where this trial is running
Chicago, Illinois and 1 other locations
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.