Recruiting NCT06025682

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

Trial Parameters

Condition Acute Lymphoblastic Leukemia

Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Type OBSERVATIONAL

Phase N/A

Enrollment 158

Sex ALL

Min Age 18 Years

Max Age N/A

Start Date 2024-04-04

Completion 2025-01

All Conditions

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

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

Eligibility Criteria

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.

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