Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392581
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-01
Brief Title:
Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALL-IFI
Brief Summary:
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy from onset to TP2 ie 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 010622 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
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 010622 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 ie 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 010622 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 BT lymphoblastic lymphoma Primary endpoint
Incidence of IFI during the early stages of chemotherapy from onset to TP2 ie 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 01032022 for a duration of 18 months The follow-up time after enrollment will be 12 months
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 010622 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 BT lymphoblastic lymphoma Primary endpoint
Incidence of IFI during the early stages of chemotherapy from onset to TP2 ie 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 01032022 for a duration of 18 months The follow-up time after enrollment will be 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None