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RecruitingNCT07080970ACTIVATEUpdated Jun 22, 2026

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

An observational study in Acute Myeloid Leukemia and NPM1 Mutation, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Acute Myeloid Leukemia
  • NPM1 Mutation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study 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.

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

Exclusion Criteria:

  • No specific exclusion criteria are provided once eligibility criteria are met.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (estimated)
Patient registry
No

Groups and cohorts

  • APL-like

    NPM1 AML patients identified as APL-like cohort

    Other: observation of incidence of early vascular events

  • Non APL-like

    NPM1 AML patients identified as no APL-like cohort

    Other: observation of incidence of early vascular events

Interventions

  • Otherobservation of incidence of early vascular events

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

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • SOD Ematologia, Università di Firenze, AOU Careggi
    Florence, Italy
    Recruiting
07

Registry details

Key details

Study ID
NCT07080970
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Responsible party
Sponsor
First posted
Jul 23, 2025
Start date
Jul 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Nov 2028 (estimated)
Last update
Jun 22, 2026

Study contacts

Paola Fazi
Contact
p.fazi@gimema.it
0670390528
Enrico Crea
Contact
e.crea@gimema.it
0670390514
Francesco Mannelli
principal investigator · SOD Ematologia, Università di Firenze, AOU Careggi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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