RecruitingNCT06025682

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

Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)


Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Enrollment

158 participants

Start Date

Apr 4, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study (no experimental treatment) is tracking outcomes for adult patients with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) who were treated with a drug called inotuzumab ozogamicin (INO). The study focuses specifically on complications like infections and liver problems that can occur after this treatment. **You may be eligible if...** - You are an adult (over 18) with relapsed or hard-to-treat B-ALL that has a CD22-positive marker - You received inotuzumab ozogamicin (INO) as part of your standard medical care (not as part of another trial) - You had a certain genetic mutation (Philadelphia chromosome-positive ALL) and failed at least one prior targeted therapy **You may NOT be eligible if...** - You received inotuzumab ozogamicin as part of an interventional clinical trial (vs. standard care) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

UOC Ematologia Fondazione Policlinico Universitario A.Gemelli

Roma, Italy

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NCT06025682


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