AML (Acute Myelogenous LeukemiaAML-FITNESSNCT07598838
Fitness in Elderly AML Patients
An observational study of AML (Acute Myelogenous Leukemia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- AML (Acute Myelogenous Leukemia
- What is being tested?
- Fitness Categories: FIT, UNFIT and FRAIL
- How many people
- 725 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly aml patients
Acute Myeloid Leukemia Diagnosis no Acute Promyelocytic Leukemia aged more than 65 years
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the 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)
- Conditions
- AML (Acute Myelogenous Leukemia
- Being tested
- Fitness Categories: FIT, UNFIT and FRAIL
- Keywords
- fitness, elderly, treatment
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness Categories: FIT, UNFIT and FRAILOther
fitness categories and treatment received
| Study group | Role | What they receive |
|---|---|---|
| elderly aml patients | Not described Receives: Other: Fitness Categories: FIT, UNFIT and FRAIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival according to fitness categories and treatment received
Measured: "From enrollment to the end of treatment at 12 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jan 2020
- Primary completion30 Jun 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Borlenghi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598838
- Sponsor's protocol ID
- NP 5964
- Acronym
- AML-FITNESS
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07598838
- Acronym / sponsor ID
- AML-FITNESS / NP 5964
- Conditions
- AML (Acute Myelogenous Leukemia
- Keywords
- fitness, elderly, treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly aml patients | – | Other: Fitness Categories: FIT, UNFIT and FRAIL |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly aml patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness Categories: FIT, UNFIT and FRAILfitness categories and treatment received | Other | elderly aml patients |
Primary outcome
overall survival according to fitness categories and treatment received
Time frame: "From enrollment to the end of treatment at 12 months"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML (Acute Myelogenous Leukemia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival according to fitness categories and treatment received (time frame: "From enrollment to the end of treatment at 12 months"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.