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OpenTrials
Active, Not Recruiting

NCT Number: NCT07598838

Fitness in Elderly AML Patients

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

AML (Acute Myelogenous Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fitness Categories: FIT, UNFIT and FRAIL

Other

fitness categories and treatment received

Primary outcomes

  1. overall survival according to fitness categories and treatment received

    Time frame: "From enrollment to the end of treatment at 12 months"

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

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

Acronym: AML-FITNESS

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 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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