NCT07598838

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).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
725

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

5.5 years

First QC Date

May 14, 2026

Last Update Submit

May 14, 2026

Conditions

AML (Acute Myelogenous Leukemia

Keywords

fitnesselderlytreatment

Outcome Measures

Primary Outcomes (1)

  • overall survival according to fitness categories and treatment received

    "From enrollment to the end of treatment at 12 months"

Study Arms (1)

elderly aml patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elderly aml patients

* patients aged more 65 years with aml diagnosis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 20, 2026

Study Start

January 1, 2020

Primary Completion

June 30, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

IT(1)