Actively Recruiting
Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients
Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2024-08-06
150
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with B Ph-neg or T acute lymphoblastic leukemia at onset
- Age greater than 18 years at the time of the study
- Signed informed consent
You will not qualify if you...
- Patients with Philadelphia chromosome-positive acute lymphoblastic leukemia
- Patients with relapsing acute lymphoblastic leukemia
- Patients with B or T lymphoblastic lymphoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
Research Team
C
chiara cattaneo, md
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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