MedTrace Logo

Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients

NCT06392581 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-08-06

No results posted yet for this study

Summary

Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives

* To document the occurrence of IFI in relation to antifungal prophylaxis adopted
* To document the occurrence of IFI in relation to the age of the patients
* Document the occurrence of IFI in relation to the duration of neutropenia
* Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
* Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
* Document the outcome of patients with ALL with IFI

Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.

The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:

* Age
* Sex
* Type of AF prophylaxis performed
* LLA risk classification according to ESMO 2016 criteria
* Dose of dexamethasone administered
* Duration of neutropenia
* Hematologic and molecular response

Conditions

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • chiara cattaneo, md · ASST Spedali Civili di Brescia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2024-03-12
Completion
2025-12-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392581 on ClinicalTrials.gov