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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Not yet enrolling

Conditions: NPM1 Mutation; Acute Myeloid Leukemia

Treatments: Other: observation of incidence of early vascular events

Study type: Observational

Funder types: Other

Identifiers

NCT07080970

AML3025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

220 participants in 2 patient groups

APL-like

Description:

NPM1 AML patients identified as APL-like cohort

Treatment:

Other: observation of incidence of early vascular events

Non APL-like

Description:

NPM1 AML patients identified as no APL-like cohort

Treatment:

Other: observation of incidence of early vascular events