Prospective observational study on invasive fungal infection (IFI) incidence in Ph-negative acute lymphoblastic leukemia (ALL) patients. SEIFEM ALL-IFI 2022 Study

Objectives of the study: 

Primary

To evaluate the incidence of invasive fungal infections (IFI) during the first 3 courses.

Secondary

To evalute IFI incidence in relation to:

• Age
• Antifungal prophylaxis
• Duration of neutropenia
• Type of steroid treatment

– To evaluate treatment delay in ALL patients with IFI
– To evaluate the outcome of ALL patients with IFI

Study design:

The proposed clinical-epidemiological study is a prospective, observational, multicenter, real-life study. All patients with Ph-negative ALL treated with intensive chemotherapy starting from 06/01/22 for a duration of 18 months (+12 months of follow-up) will be enrolled

Population:

Inclusion Criteria:

• Patients with B or T-cell ALL at diagnosis.
• Age > 18 years at the time of study enrollment.
• Signed informed consent

Exclusion Criteria:

• Patients with Philadelphia chromosome-positive ALL.
• Patients with relapsed ALL.
• Patients with B/T-cell lymphoblastic lymphoma.