Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (G… (NCT05544032) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)
Plain-language summary
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.
Who can participate
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:
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Exclusion Criteria:
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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.
1Since axatilimab has now been approved for marketing rather than being in an experimental trial phase, can you walk me through how that changes my access to it and whether it could be prescribed to me directly instead of through an expanded access program?
2This was originally set up as expanded access for a single patient with chronic GVHD — does that history tell us anything about how limited the real-world safety and outcomes data still is for this drug, and what that means for my situation?
3Given that chronic GVHD can vary a lot in severity and which organs are affected, do you think my specific type and stage of chronic GVHD is the kind this drug was designed to target?
4Are there standard treatments for chronic GVHD that I should try first, or that might work alongside axatilimab, before or instead of going this route?
5What would you be watching for to know whether axatilimab is actually working for me, and what side effects should I be prepared to report to you right away?
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.