Observational Study on APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions
NCT ID: NCT07080970
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
220 participants
OBSERVATIONAL
2025-11-30
2028-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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APL-like
NPM1 AML patients identified as APL-like cohort
observation of incidence of early vascular events
observation of difference incidence of early vascular events in the two cohorts
Non APL-like
NPM1 AML patients identified as no APL-like cohort
observation of incidence of early vascular events
observation of difference incidence of early vascular events in the two cohorts
Interventions
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observation of incidence of early vascular events
observation of difference incidence of early vascular events in the two cohorts
Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Francesco Mannelli
Role: PRINCIPAL_INVESTIGATOR
SOD Ematologia, Università di Firenze, AOU Careggi
Central Contacts
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Other Identifiers
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AML3025
Identifier Type: -
Identifier Source: org_study_id
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