Fitness in Elderly AML Patients (AML-FITNESS)

May 20, 2026 updated by: Erika Borlenghi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

725

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Asst Spedali Civili Di Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

elderly aml patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
elderly aml patients
Other: Fitness Categories: FIT, UNFIT and FRAIL
fitness categories and treatment received

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival according to fitness categories and treatment received
Time Frame: "From enrollment to the end of treatment at 12 months"
"From enrollment to the end of treatment at 12 months"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2025

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 5964

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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