New study investigates why some AML patients face early bleeding or clotting risks
NCT ID NCT07080970
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This observational study examines a specific group of patients with a type of acute myeloid leukemia (AML) that has an NPM1 mutation. Researchers want to see if a particular subset, called APL-like, is linked to early blood vessel problems like bleeding or clots. The study will look back at past cases and also follow new patients to better understand this connection. It does not test any new treatment, but aims to improve knowledge about this disease.
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 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study cohort will include NPM1mut AML patients with an immunophenotypic characterization at diagnosis that allows the classification into APL-like and non-APL-like AML.
- Ages
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18 years and older
- 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: * Patients with de novo AML, untreated, newly diagnosed, according to WHO/ICC 2022 criteria from January 2015 onwards. * Presence of NPM1 mutation. * Availability of immunophenotypic characterization at diagnosis * Age \>= 18 years * Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable) Exclusion Criteria: * No specific exclusion criteria are provided once eligibility criteria are met.
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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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SOD Ematologia, Università di Firenze, AOU Careggi
RECRUITINGFlorence, Italy
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