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NCT Number: NCT07080970

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute NPM1 Mutation Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SOD Ematologia, Università di Firenze, AOU Careggi

Florence, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation of incidence of early vascular events

Other

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

Primary outcomes

  1. Incidence of early vascular events

    Time frame: 30 days from diagnosis

    Evaluation of the incidence of early vascular events (haemorrhagic and/or thrombotic) in the APL-like and non-APL-like subsets.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

0670390514

Paola Fazi

CONTACT

[email protected]

0670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study 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)

Acronym: ACTIVATE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 23, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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