Can a simple blood test make a key transplant drug safer?
NCT ID NCT05711732
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study collects blood samples from children and adults receiving the chemotherapy drug busulfan before a stem cell transplant. The goal is to compare a new, faster test with standard lab methods for measuring drug levels in the blood. If the new test works well, it could help doctors adjust each patient's dose to avoid toxic side effects or underdosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- busulfan (the drug being monitored, not tested as an intervention)
- What this could lead to
- If the new test proves accurate, doctors could personalize busulfan doses for each patient, potentially reducing side effects and improving transplant outcomes.
- What could go wrong
- This is an early method-comparison study, not a treatment trial. The test may not prove reliable enough for routine use, and no direct patient benefit is guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Robert H. Lurie Comprehensive Cancer Center of Northwestern University
ACTIVE_NOT_RECRUITINGChicago, Illinois, 60611, United States
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Rutgers Cancer Institute
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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The University of Texas MD Anderson Cancer Center
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
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