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

NCT ID: NCT07080970

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-11-30

Brief Summary

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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.

Detailed Description

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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.

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.

Conditions

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Acute Myeloid Leukemia NPM1 Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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APL-like

NPM1 AML patients identified as APL-like cohort

observation of incidence of early vascular events

Intervention Type OTHER

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

Non APL-like

NPM1 AML patients identified as no APL-like cohort

observation of incidence of early vascular events

Intervention Type OTHER

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

Interventions

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observation of incidence of early vascular events

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Mannelli

Role: PRINCIPAL_INVESTIGATOR

SOD Ematologia, Università di Firenze, AOU Careggi

Central Contacts

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Paola Fazi

Role: CONTACT

0670390528

Enrico Crea

Role: CONTACT

0670390514

Other Identifiers

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AML3025

Identifier Type: -

Identifier Source: org_study_id

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