Clinical trial NCT05711732: Busulfan Sample Collection Study
Official title: Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subjects Treated With Busulfan
Lead sponsor: Saladax Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Method Comparison Study
timeFrame: Sample collection to take place over 1 year. Samples to be analyzed monthly.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: