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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APL-like | NPM1 AML patients identified as APL-like cohort |
| |
| Non APL-like | NPM1 AML patients identified as no APL-like cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation of incidence of early vascular events | Other | observation of difference incidence of early vascular events in the two cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early vascular events | Evaluation of the incidence of early vascular events (haemorrhagic and/or thrombotic) in the APL-like and non-APL-like subsets. | 30 days from diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Fazi | Contact | 0670390528 | p.fazi@gimema.it | |
| Enrico Crea | Contact | 0670390514 | e.crea@gimema.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Mannelli | SOD Ematologia, Università di Firenze, AOU Careggi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOD Ematologia, Università di Firenze, AOU Careggi | Recruiting | Florence | Italy |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |