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Fitness in Elderly AML Patients

Multicenter Retrospective Observational Study to Verify the Application of SIE/SIES/GITMO FITNESS CRITERIA to Guide Therapeutic Choice in Elderly Patients With Acute Myeloid Leukemia in Light of the Availability of New Drugs - AML FITNESS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07598838
Acronym
AML-FITNESS
Enrollment
725
Registered
2026-05-20
Start date
2020-01-01
Completion date
2026-05-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML (Acute Myelogenous Leukemia

Keywords

fitness, elderly, treatment

Brief summary

The study aims to evaluate the outcome of patients (overall survival) who received treatments commensurate with the proposed "Fitness" parameters compared to that of patients whose treatment differed either in the direction of greater or lesser aggressiveness than that proposed (evaluation of survival through Kaplan-Meier analysis and comparison with the log-rank test).

Detailed description

Evaluate adherence to SIE/SIES/GITMO criteria in therapeutic choice: assess the treatment actually received by the different patient groups and any deviations from those proposed (descriptive statistics) * Evaluate whether the SIE/SIES/GITMO criteria are still current after the introduction of new drugs (descriptive statistics) * Evaluate the treatment actually received by the different patient groups and any deviations from those proposed * Evaluate the possibility of potentially identifying new criteria to better define fitness categories in light of the therapy actually administered to the patient (descriptive statistics)

Interventions

OTHERFitness Categories: FIT, UNFIT and FRAIL

fitness categories and treatment received

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Acute Myeloid Leukemia Diagnosis no Acute Promyelocytic Leukemia aged more than 65 years

Design outcomes

Primary

MeasureTime frame
overall survival according to fitness categories and treatment received"From enrollment to the end of treatment at 12 months"

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026