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

Acute Lymphoblastic Leukemia Clinical Trial

— ALL-IFI  

Official title:

Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392581
• Other study ID #: SEIFEM ALL-IFI 2022_NP 5250
• Status: Recruiting
• Start date: April 14, 2022
• Est. completion date: June 14, 2024

Study information

• Verified date: April 2024
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: chiara cattaneo, md
• Phone: 03039951
• Email: chiara.cattaneo[@]asst-spedalicivili.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 14, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Infections
• Invasive Fungal Infections
• Leukemia
• Leukemia, Lymphoid
• Mycoses
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Italy	ASST degli Spedali Civili di Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	16 weeks
Secondary	- 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	16 weeks
Secondary	- 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	16 weeks
Secondary	- 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	16 weeks
Secondary	- 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)	16 weeks
Secondary	- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI	- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI	16 weeks
Secondary	Patient mortality rate in Ph-neg ALL patients with IFI	Patient mortality rate in Ph-neg ALL patients with IFI	16 weeks