Observational Study on APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions

NCT07080970 · tracked via the Priya Life Science Italy tracker

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Phase

Observational

Started

2026-07

Last updated

2026-06-22

Condition(s) studied

Acute Myeloid LeukemiaNPM1 Mutation

Investigational drug(s) / intervention(s)

observation of incidence of early vascular events

observation of incidence of early vascular events: observation of difference incidence of early vascular events in the two cohorts

Study summary

This is a multicenter observational study with a retrospective and a prospective cohort investigating clinically and biologically the APL-like subset as a potential predictor of coagulopathy and susceptibility to early vascular events.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of early vascular events — 30 days from diagnosis
Evaluation of the incidence of early vascular events (haemorrhagic and/or thrombotic) in the APL-like and non-APL-like subsets.

Trial sites (1)

Facility	City	Region	Status
SOD Ematologia, Università di Firenze, AOU Careggi	Florence	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07080970 on ClinicalTrials.gov ↗ ← All trials in Italy