RecruitingNot Applicable

Busulfan Sample Collection Study

United States150 participantsStarted 2024-02-08

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Method Comparison Study

Timeframe: Sample collection to take place over 1 year. Samples to be analyzed monthly.

Trial details

NCT IDNCT05711732

SponsorSaladax Biomedical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Subjects Treated With Busulfan trials