Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative (SEIFEM)

April 30, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with B or T acute lymphoblastic leukemia Ph negative

Description

Inclusion Criteria:

  • diagnosis of acute lymphoblastic leukemia Ph negative
  • age more than 18 yo

Exclusion Criteria:

  • diagnosis of acute lymphoblastic leukemia Ph positive
  • acute lymphoblastic leukemia relapsed/refractory
  • lymphoblastic lymphoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients without invasive fungal infection
Acute lymphoblastic leukemia, no invasive fungal infection
Patients with invasive fungal infection
Acute lymphoblastic leukemia, invasive fungal infection
Other: observation of invasive fungal infections
observation of invasive fungal infections during chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of invasive fungal infections
Time Frame: 18 months
Incidence of invasive fungal infections during first week of chemotherapy
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 30 months
Mortality rate among patients with invasive fungal infections
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Azienda Ospedaliera Universitaria Integrata Verona
Azienda Sanitaria Universitaria Friuli Centrale
University of Rome Tor Vergata
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Azienda Ospedaliera di Padova
Istituto Oncologico Veneto IRCCS
Campus Bio-Medico University
Azienda Ospedaliero-Universitaria di Parma
University of Modena and Reggio Emilia
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Azienda Ospedaliera San Gerardo di Monza
San Raffaele University Hospital, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
San Giovanni Addolorata Hospital
Azienda Ospedaliera "Sant'Andrea"
Ospedale San Bortolo di Vicenza
S.Eugenio Hospital
Vito Fazzi Hospital
A.O.U. Città della Salute e della Scienza
Asst Degli Spedali Civili Di Brescia
Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo
ASST Sette Laghi
San Gallicano Dermatological Institute IRCCS

Investigators

  • Principal Investigator: Marianna Criscuolo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Fungal Infections

Clinical Trials on observation of invasive fungal infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe