Acute Lymphoblastic Leukemia, AdultSEIFEMNCT05750706
Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
An observational study of Acute Lymphoblastic Leukemia, Adult and Invasive Fungal Infections, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult, Invasive Fungal Infections
- What is being tested?
- observation of invasive fungal infections
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 31 Mar 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients with B or T acute lymphoblastic leukemia Ph negative
Who may be able to join
- diagnosis of acute lymphoblastic leukemia Ph negative
- age more than 18 yo
Who cannot join
- diagnosis of acute lymphoblastic leukemia Ph positive
- acute lymphoblastic leukemia relapsed/refractory
- lymphoblastic lymphoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment
- Being tested
- observation of invasive fungal infections
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of invasive fungal infectionsOther
observation of invasive fungal infections during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients without invasive fungal infection | Acute lymphoblastic leukemia, no invasive fungal infection | |
| Patients with invasive fungal infection | Acute lymphoblastic leukemia, invasive fungal infection Receives: Other: observation of invasive fungal infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of invasive fungal infections
Incidence of invasive fungal infections during first week of chemotherapy
Measured: 18 months
Secondary outcomes (1)
Mortality rate
Mortality rate among patients with invasive fungal infections
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Jun 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, AdultStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Asst Degli Spedali Civili Di Brescia, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Campus Bio-Medico University, Azienda Sanitaria Universitaria Friuli Centrale, San Gallicano Dermatological Institute IRCCS, University of Rome Tor Vergata, University of Modena and Reggio Emilia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Vito Fazzi Hospital, Azienda Ospedaliera di Padova, San Raffaele University Hospital, Italy, Azienda Ospedaliera Universitaria Integrata Verona, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera "Sant'Andrea", S.Eugenio Hospital, San Giovanni Addolorata Hospital, IRCCS Casa Sollievo della Sofferenza, ASST Sette Laghi, Ospedale San Bortolo di Vicenza, Fondazione IRCCS Policlinico San Matteo di Pavia, A.O.U. Città della Salute e della Scienza, Istituto Oncologico Veneto IRCCS, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Responsible party
- Sponsor
- Investigators
- Marianna Criscuolo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750706
- Sponsor's protocol ID
- 4976
- Acronym
- SEIFEM
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2023
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative
- ClinicalTrials.gov ID
- NCT05750706
- Acronym / sponsor ID
- SEIFEM / 4976
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Asst Degli Spedali Civili Di Brescia, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Campus Bio-Medico University, Azienda Sanitaria Universitaria Friuli Centrale, San Gallicano Dermatological Institute IRCCS, University of Rome Tor Vergata, University of Modena and Reggio Emilia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Vito Fazzi Hospital, Azienda Ospedaliera di Padova, San Raffaele University Hospital, Italy, Azienda Ospedaliera Universitaria Integrata Verona, Azienda Ospedaliero-Universitaria di Parma, Azienda Ospedaliera "Sant'Andrea", S.Eugenio Hospital, San Giovanni Addolorata Hospital, IRCCS Casa Sollievo della Sofferenza, ASST Sette Laghi, Ospedale San Bortolo di Vicenza, Fondazione IRCCS Policlinico San Matteo di Pavia, A.O.U. Città della Salute e della Scienza, Istituto Oncologico Veneto IRCCS, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 2 Mar 2023 (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 incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without invasive fungal infection | – | –Acute lymphoblastic leukemia, no invasive fungal infection |
| Patients with invasive fungal infection | – | Other: observation of invasive fungal infectionsAcute lymphoblastic leukemia, invasive fungal infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with B or T acute lymphoblastic leukemia Ph negative
Key inclusion criteria (2 listed)
- diagnosis of acute lymphoblastic leukemia Ph negative
- age more than 18 yo
Key exclusion criteria (3 listed)
- diagnosis of acute lymphoblastic leukemia Ph positive
- acute lymphoblastic leukemia relapsed/refractory
- lymphoblastic lymphoma
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 |
|---|---|---|
| observation of invasive fungal infectionsobservation of invasive fungal infections during chemotherapy | Other | Patients with invasive fungal infection |
Primary outcome
Incidence of invasive fungal infections
Time frame: 18 months
Incidence of invasive fungal infections during first week of chemotherapy
1 secondary outcome
Mortality rate
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marianna Criscuolo principal investigator
Fondazione Policlinico Universitario Agostino 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 Lymphoblastic Leukemia, Adult and Invasive Fungal Infections, 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 2 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: finished, as of the sponsor's last update on 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of invasive fungal infections (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 6 May 2026.