Multicenter retrospective observational study analyzing infective complications and the clinical outcome of patients with acute lymphoblastic leukemia treated with inotuzumab ozogamicin (INO-FIRST) . GIMEMA INF0123

Principal Investigator: Livio Pagano

Co-Principal Investigator: Anna Candoni

Objectives of the study: 

Primary

To evaluate the clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia (ALL) patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).

Secondary

To evaluate:

• the infection-related mortality in patients receiving INO up to 60 days after the end of treatment (last dose administered);
• the impact of infective complications on therapeutic program;
• overall survival (OS);
• hospital admission due to infective and non-infective complications;
• allo-SCT feasibility after INO;
• the mortality attributable to non-infective complications;
• the use of antibacterial, antifungal and antiviral prophylaxis and therapy;
• infectious and non-infectious complications occurring in patients receiving allo-stem cell transplant after INO;
• incidence of infective complications according to clinico-biological features of the disease;
• impact of infective complications on the OS.

Study design:

The present study is a multicenter, retrospective, observational clinical-epidemiological study. The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B- ALL patients with INO over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).

Population:

Inclusion Criteria:

• Adult patients (>18 years old)
• Patients with relapsed/refractory CD-22 positive B-ALL treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one tyrosine-kinase inhibitor

Signed informed consent if applicable.