Busulfan Sample Collection Study

NCT05711732 | Recruiting

• 1 other identifier: SBI-BSF-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Subjects Treated With Busulfan

Outcome Measures

Primary Outcomes (1)

• Method Comparison Study

  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 .

  Sample collection to take place over 1 year. Samples to be analyzed monthly.

Interventions

MyCare Oncology Busulfan Assay Kit DIAGNOSTIC_TEST

This is a sample collection study only. Patient treatment will not be determined by the outcome of the analytical test results.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 150 unique subjects across participating sites consisting of males and females who meet the protocol Inclusion/ Exclusion criteria as described above. Multiple (3 to 12) plasma samples by venous draw will be collected from each subject for a single day of busulfan dosing. Sample collection timing used to inform dose calculation shall be performed per the site standard of clinical care for patients prescribed busulfan.

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to follow protocol requirements or to give written informed consent;
• Patients receiving oral busulfan (e.g., Myleran®) treatment.

Sponsors & Collaborators

• Saladax Biomedical, Inc.: lead

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

human plasma samples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: February 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (2)