NCT07080970

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Nov 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Nov 2025Nov 2028

First Submitted

Initial submission to the registry

July 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

July 15, 2025

Last Update Submit

July 15, 2025

Conditions

Acute Myeloid LeukemiaNPM1 Mutation

Outcome Measures

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.

    30 days from diagnosis

Study Arms (2)

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

observation of incidence of early vascular eventsOTHER

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

APL-likeNon APL-like

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Francesco Mannelli

    SOD Ematologia, Università di Firenze, AOU Careggi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514e.crea@gimema.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 23, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

July 23, 2025

Record last verified: 2025-07