Recruiting NCT07080970

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

— Observational Acute Myeloid Leukemia NPM1 Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: observation of incidence of early vascular events.
Who it may be relevant to: Registry conditions: Acute Myeloid Leukemia, NPM1 Mutation. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Observational Study on APL-like Subset Within NPM1-mutated Acute Myeloid Leukemia: a Distinct Phenotypic Signature Correlating With Early-onset Vascular Complications. ACTIVATE (APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions)

Overview

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

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

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

Primary outcome measures

Incidence of early vascular events [Time frame: 30 days from diagnosis]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Italy · 1 center

SOD Ematologia, Università di Firenze, AOU Careggi — Florence

Identifiers

NCT: NCT07080970 · AML3025

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗