Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients (ALL-IFI)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status

Enrolling

Conditions

Acute Lymphoblastic Leukemia

Study type

Observational

Funder types

Other

Identifiers

NCT06392581

SEIFEM ALL-IFI 2022_NP 5250

Details and patient eligibility

About

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

Full description

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

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

Inclusion criteria

Patients with ALL B Ph-neg or T at onset
Age > 18 yr at the time of the study
Signature informed consent Exclusion criteria
Patients with Ph-pos ALL
Patients with relapsing ALL
Patients with B/T lymphoblastic lymphoma Primary endpoint
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients.

Secondary endpoints

Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
Patient mortality rate in Ph-neg ALL patients with IFI Study Duration All eligible patients will be enrolled from 01.03.2022 for a duration of 18 months. The follow-up time after enrollment will be 12 months.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria