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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

Acute Lymphoblastic LeukemiaInfectionsViral InfectionAcute Lymphoblastic Leukemia, in RelapseBacterial InfectionsAcute Lymphoblastic Leukemia, AdultFungal Infection

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

Inclusion Criteria3

  • 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 Criteria1

  • • Patients treated with INO in interventional clinical trials.

Locations(1)

UOC Ematologia Fondazione Policlinico Universitario A.Gemelli

Roma, Italy

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NCT06025682

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