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

Phase

N/A

Condition

Leukemia

Bacterial Infections

Candidemia/candidiasis

Treatment

N/A

Clinical Study ID

NCT06025682

INF0123

Ages > 18
All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adult patients (>18 years old)
Patients with relapsed/refractory CD22 positive B-ALL treated with INO or withrelapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failingat least one TKI inhibitor
Signed informed consent if applicable.

Exclusion

Exclusion Criteria:

• Patients treated with INO in interventional clinical trials.

Study Design

April 04, 2024

January 31, 2025

Study 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).

Connect with a study center

UOC Ematologia Fondazione Policlinico Universitario A.Gemelli
Roma,
Italy
Active - Recruiting

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