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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with B Ph-neg or T ALL at onset

Age > 18 yr at the time of the study

Signature informed consent

Disqualifiers

Patients with Ph-pos ALL

Patients with relapsing ALL

Patients with B/T lymphoblastic lymphoma

Trial population

Patients affected by Ph-pos ALL

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients

Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients

Time frame
16 weeks

Secondary outcomes

1

- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted

\- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted

Time frame
16 weeks
2

- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age

\- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age

Time frame
16 weeks
3

- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia

\- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia

Time frame
16 weeks
4

- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)

\- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)

Time frame
16 weeks

Other outcomes

Sponsors and contacts

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