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

NCT06392581 | Recruiting

• 1 other identifier: SEIFEM ALL-IFI 2022_NP 5250
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Lymphoblastic Leukemia

Keywords

invasive fungal infections; acute lymphoblastic leukemia; outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• - Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted

  16 weeks

• - Incidence of IFI in patients with Ph-neg ALL during induction in relation to age

  16 weeks

• - 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 in relation to type of steroid treatment adopted (dexamethasone yes vs no)

  16 weeks

• - Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI

  16 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by Ph-pos ALL

You may qualify if:

• Patients with B Ph-neg or T ALL at onset
• Age \> 18 yr at the time of the study
• Signature informed consent

You may not qualify if:

• Patients with Ph-pos ALL
• Patients with relapsing ALL
• Patients with B/T lymphoblastic lymphoma

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• chiara cattaneo, md

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chiara cattaneo, md

CONTACT

03039951; chiara.cattaneo@asst-spedalicivili.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology inpatient unit

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 30, 2024
• Study Start: April 14, 2022
• Primary Completion: March 12, 2024
• Study Completion: December 30, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)