Acute Myeloid LeukemiaEPIAMLINFNCT06797648
Epidemiology of Infection in Acute Myeloid Leukemia (AML)
An observational study of Acute Myeloid Leukemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In recent years, multiple factors have strongly impacted the epidemiology of infections in patients with acute myeloid leukemia. On the one hand, the availability of new effective antileukemic drugs (i.e. venetoclax, FLT-3 inhibitors, CPX-351) have expanded the pharmacological armamentarium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- data analysis
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 30 Jun 2029
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population must be ≥18 years of age with a new diagnosis AML and microbiologically/clinically documented bacterial/fungal/viral infection. Patients with fever of unidentified origin (FUO) could be included. In order to obtain a denominator for all cases of AML, it is required to fill out the eCRF. The form must be filled out for each phase of treatment (i.e. induction, consolidation, relapsed, refractory). Patients stop recording when they go to HSCT.
Who may be able to join
- Ability to sign the consent form
- Age ≥18 years
- New diagnosis of AML (only cases diagnosed after 01/03/2025), APL are included
- Patients not elegible to any kind of chemotherapy but only best supportive care (BSC)
- AML patients treated with induction treatment, consolidation treatment, or relapsed/refractory (for these latter patients the first diagnosis must not be prior to March 01, 2025)
- All kind of infectious diseases, including parasites.
- Clincally or microbiologically diagnosed infections, including FUO
Who cannot join
- Hematological diseases, other than AML
- Patients with an AML diagnosis prior to March 2025 but who relapsed during the period under examination
- Patients relapsed after allo or auto-HSCT (Inclusion of post-transplant patients would create an evaluation bias due to the immunological alterations that the transplant procedure causes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli Irccs, Uoc Ematologia
Rome, 00168
LIVIO PAGANO, PROF, +390630155530, LIVIO.PAGANO@POLICLINICOGEMELLI.IT
LIVIO PAGANO, PROF
About this study
Official title: Epidemiology of Infection in AML, A European Haematology Association Survey
In recent years, multiple factors have strongly impacted the epidemiology of infections in patients with acute myeloid leukemia. On the one hand, the availability of new effective antileukemic drugs (i.e. venetoclax, FLT-3 inhibitors, CPX-351) have expanded the pharmacological armamentarium. On the other hand, first, many of them inhere drug-drug interactions with azoles and fluoroquinolones, facing clinicians with the choice of whether to administer antimicrobial prophylaxis or not. Secondly, there is an increase in infections due to multi-resistant agents from both the bacterial and fungal field. Third, the onset of a viral pandemic that had high relevance in these patients in terms of morbidity and mortality.
The aim of this survey is to collect information on the largest possible sample of patients with AML during induction/consolidation/relapsed-refractory treatment, regarding bacterial, viral, fungal infections. We will evaluate the incidence of the various types of infection in relation to the type of treatment that patients will undergo, in order to identify what should be the best antimicrobial prophylactic approach in each subset of patients.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- data analysis
- 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.
data analysisOther
follow up after 15 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bacterial/fungal/viral infections in AML patients
To evaluate the incidence of bacterial/fungal/viral infections in AML patients undergoing induction, consolidation or salvage chemotherapy.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LIVIO PAGANO, PROF, Principal investigator, FONDAZIONE POLICLINICO GEMELLI, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797648
- Sponsor's protocol ID
- 7283
- Acronym
- EPIAMLINF
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Infection in AML, A European Haematology Association Survey
- ClinicalTrials.gov ID
- NCT06797648
- Acronym / sponsor ID
- EPIAMLINF / 7283
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 Jan 2025 (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.
In recent years, multiple factors have strongly impacted the epidemiology of infections in patients with acute myeloid leukemia. On the one hand, the availability of new effective antileukemic drugs (i.e. venetoclax, FLT-3 inhibitors, CPX-351) have expanded the pharmacological armamentarium. On the other hand, first, many of them inhere drug-drug interactions with azoles and fluoroquinolones, facing clinicians with the choice of whether to administer antimicrobial prophylaxis or not. Secondly, there is an increase in infections due to multi-resistant agents from both the bacterial and fungal field. Third, the onset of a viral pandemic that had high relevance in these patients in terms of morbidity and mortality.
The aim of this survey is to collect information on the largest possible sample of patients with AML during induction/consolidation/relapsed-refractory treatment, regarding bacterial, viral, fungal infections. We will evaluate the incidence of the various types of infection in relation to the type of treatment that patients will undergo, in order to identify what should be the best antimicrobial prophylactic approach in each subset of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population must be ≥18 years of age with a new diagnosis AML and microbiologically/clinically documented bacterial/fungal/viral infection. Patients with fever of unidentified origin (FUO) could be included. In order to obtain a denominator for all cases of AML, it is required to fill out the eCRF. The form must be filled out for each phase of treatment (i.e. induction, consolidation, relapsed, refractory). Patients stop recording when they go to HSCT.
Key inclusion criteria (7 listed)
- Ability to sign the consent form
- Age ≥18 years
- New diagnosis of AML (only cases diagnosed after 01/03/2025), APL are included
- Patients not elegible to any kind of chemotherapy but only best supportive care (BSC)
- AML patients treated with induction treatment, consolidation treatment, or relapsed/refractory (for these latter patients the first diagnosis must not be prior to March 01, 2025)
Key exclusion criteria (3 listed)
- Hematological diseases, other than AML
- Patients with an AML diagnosis prior to March 2025 but who relapsed during the period under examination
- Patients relapsed after allo or auto-HSCT (Inclusion of post-transplant patients would create an evaluation bias due to the immunological alterations that the transplant procedure causes)
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 |
|---|---|---|
| data analysisfollow up after 15 months | Other | – |
Primary outcome
Incidence of bacterial/fungal/viral infections in AML patients
Time frame: 18 months
To evaluate the incidence of bacterial/fungal/viral infections in AML patients undergoing induction, consolidation or salvage chemotherapy.
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 28 Jan 2025.
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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.
LIVIO PAGANO, PROF principal investigator
FONDAZIONE POLICLINICO GEMELLI, IRCCS
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 Acute Myeloid Leukemia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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?
The sponsor lists 7 inclusion and 3 exclusion criteria. 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: opening soon, as of the sponsor's last update on 28 Jan 2025. 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?
Contact LIVIO PAGANO (+390630155530, LIVIO.PAGANO@POLICLINICOGEMELLI.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bacterial/fungal/viral infections in AML patients (time frame: 18 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 28 Jan 2025.