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

RECRUITINGSponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto
Actively Recruiting
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
Started2024-04-04
Est. completion2025-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06025682

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions8

Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia, AdultAcute Lymphoblastic Leukemia, in RelapseBacterial InfectionsCancerFungal InfectionInfectionsViral Infection

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