Spots Global Cancer Trial Database for Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO

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Trial Identification

Brief Title: Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO

Official Title: Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)

Study ID: NCT06025682

Conditions

Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia, Adult

Acute Lymphoblastic Leukemia, in Relapse

Interventions

Study Description

Brief Summary: The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is: • incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment

Detailed Description: The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).