Busulfan Sample Collection Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-08

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Subjects Treated With Busulfan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No