Recruiting

Busulfan

Sponsor:

Saladax Biomedical, Inc.

Code:

NCT05711732

Conditions

Subjects Treated With Busulfan

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

MyCare Oncology Busulfan Assay Kit

Study Details

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

Study ID

NCT05711732

Start date

Feb 8, 2024

Status verified date

Jul, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Niketa C Shah, MD

732-235-2465ns1586@cinj.rutgers.edu

More Information

Sponsor

Saladax Biomedical, Inc.

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Saladax Biomedical, Inc. on 2026-07-30.