Busulfan Sample Collection Study
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Saladax Biomedical, Inc.
- Study ID
- NCT05711732
- Status
- Recruiting
Conditions
- Subjects Treated With Busulfan
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- First listed
- Feb 3, 2023
- Start date
- Feb 8, 2024
- Status verified
- Jul 2026
- Primary completion
- Jan 31, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 150 participants (estimated)
Primary Outcome Measure
Method Comparison Study [ Time Frame: Sample collection to take place over 1 year. Samples to be analyzed monthly. ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | - |
| Rutgers Cancer Institute | New Brunswick | New Jersey | 08903 | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |