Acute Myeloid Leukemia, NPM1 Mutation
Conditions
Brief 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.
Detailed description
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. Participating Centers will identify NPM1-mutated patients eligible for enrollment. The immune-phenotypic data will be evaluated to define a specific signature to be applied for the identification of APL-like AML. All patients will be followed for a minimum of 12 months until the study closure.
Interventions
OTHERobservation of incidence of early vascular events
observation of difference incidence of early vascular events in the two cohorts
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
CONTACTPaola Fazi
CONTACTEnrico Crea
PRINCIPAL_INVESTIGATORFrancesco Mannelli
SOD Ematologia, Università di Firenze, AOU Careggi
Outcome results
None listed