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NCT05711732 | Not yet recruiting | Subjects Treated With Busulfan

Busulfan Sample Collection Study
Sponsor:

Saladax Biomedical, Inc.

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

Subjects Treated With Busulfan

Intervention/treatment

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 Type : Observational
Estimated Enrollment : 150 participants
Official Title : Collection of Plasma Samples Using Sodium Heparin From Subjects Undergoing Intravenous Busulfan Treatment
Actual Study Start Date : May 15, 2023
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : June 15, 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
Busulfan Sample Collection Study

Location Details

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Busulfan Sample Collection Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

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