Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT06392581
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Patients with B Ph-neg or T ALL at onset
- Age > 18 yr at the time of the study
- Signature informed consent
- Patients with Ph-pos ALL
- Patients with relapsing ALL
- Patients with B/T lymphoblastic lymphoma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients 16 weeks Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
- Secondary Outcome Measures
Name Time Method - Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted 16 weeks - 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 16 weeks - Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI 16 weeks - Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no) 16 weeks - Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
Patient mortality rate in Ph-neg ALL patients with IFI 16 weeks Patient mortality rate in Ph-neg ALL patients with IFI
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia 16 weeks - Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
Trial Locations
- Locations (1)
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy