Busulfan Sample Collection Study

Sponsor

Saladax Biomedical, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05711732

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subjects Treated With Busulfan	Diagnostic Test: MyCare Oncology Busulfan Assay Kit

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

Jun 15, 2024

Outcome Measures

Primary Outcome Measures

Method Comparison Study [Sample collection to take place over 1 year. Samples to be analyzed monthly.]
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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Saladax Biomedical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saladax Biomedical, Inc.

ClinicalTrials.gov Identifier:

NCT05711732

Other Study ID Numbers:

SBI-BSF-001

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 3, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Busulfan

Study Results

No Results Posted as of Feb 3, 2023