Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO (INO-FIRST)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Fungal Infection; Acute Lymphoblastic Leukemia, Adult; Viral Infection; Infections; Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia, in Relapse; Bacterial Infections

Study type: Observational

Funder types: Other

Identifiers

NCT06025682

INF0123

Details and patient eligibility

About

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

Full 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).

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18 years old)
• Patients with relapsed/refractory CD22 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 TKI inhibitor
• Signed informed consent if applicable.

Exclusion criteria

• Patients treated with INO in interventional clinical trials.