Fitness in Elderly AML Patients | NCT07598838

Studies
Fitness in Elderly AML Patients

NCT07598838

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status

Active, not recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

725Actual

Phase

Not provided

Conditions

AML (Acute Myelogenous Leukemia

Interventions

Fitness Categories: FIT, UNFIT and FRAIL

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

May 30, 2026Estimated

First Submitted Date

May 14, 2026

First Submission Date that Met QC Criteria

May 14, 2026

First Posted Date

May 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erika Borlenghi, Dr., Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaPrincipal Investigator

Lead Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

725Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
elderly aml patients			Other: Fitness Categories: FIT, UNFIT and FRAIL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fitness Categories: FIT, UNFIT and FRAIL	Other	fitness categories and treatment received	elderly aml patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

elderly aml patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASST Spedali Civili di Brescia		Brescia		25123	Italy

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided