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

Gruppo Italiano Malattie EMatologiche dell'Adulto158 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

158

Conditions

Acute Lymphoblastic Leukemia Infections Bacterial Infections Viral Infection Fungal Infection Acute Lymphoblastic Leukemia, Adult

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)

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

Time frame: 5 months