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

NCT ID: NCT06392581

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2025-12-30

Brief 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

Detailed 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

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

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with B Ph-neg or T ALL 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Chiara Cattaneo

Head of Hematology inpatient unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

chiara cattaneo, md

Role: PRINCIPAL_INVESTIGATOR

ASST Spedali Civili di Brescia

Locations

ASST degli Spedali Civili di Brescia

Brescia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

chiara cattaneo, md

Role: CONTACT

chiara.cattaneo@asst-spedalicivili.it

03039951

Facility Contacts

chiara cattaneo, md

Role: primary

chiara.cattaneo@asst-spedalicivili.it

03039951

aldo roccaro, md

Role: backup

coordinamento.ricerca@asst-spedalicivili.it

03039951

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

SEIFEM ALL-IFI 2022_NP 5250

Identifier Type: -

Identifier Source: org_study_id