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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No specific exclusion criteria are provided once eligibility criteria are met.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • observation of incidence of early vascular events

    Other intervention

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: APL-like1 intervention
Group B: Non APL-like1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days from diagnosis

Secondary outcomes

Other outcomes

Sponsors and contacts

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