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NCT05750706 Clinical Trial

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

Invasive Fungal Infections Clinical Trial

Official title:
Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05750706
Other study ID # 4976
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 31, 2024

Study information
Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Chiara Cattaneo
Phone +390303996573
Email chiara.cattaneo@asst-spedalicivili.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - diagnosis of acute lymphoblastic leukemia Ph negative - age more than 18 yo Exclusion Criteria: - diagnosis of acute lymphoblastic leukemia Ph positive - acute lymphoblastic leukemia relapsed/refractory - lymphoblastic lymphoma

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• observation of invasive fungal infections
observation of invasive fungal infections during chemotherapy

Locations
Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Rome

Sponsors (2)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS ASST Spedali Civili, Brescia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of invasive fungal infections during first week of chemotherapy 18 months
Secondary Mortality rate among patients with invasive fungal infections 30 months
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