Status:

RECRUITING

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

Lead Sponsor:

Gruppo Italiano Malattie EMatologiche dell'Adulto

Conditions:

Acute Lymphoblastic Leukemia

Infections

Eligibility:

All Genders

18+ years

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 ...

Detailed Description

The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO)...

Eligibility Criteria

Inclusion

  • 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

  • • Patients treated with INO in interventional clinical trials.

Key Trial Info

Start Date :

April 4 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2025

Estimated Enrollment :

158 Patients enrolled

Trial Details

Trial ID

NCT06025682

Start Date

April 4 2024

End Date

January 1 2025

Last Update

April 11 2024

Active Locations (1)

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1

UOC Ematologia Fondazione Policlinico Universitario A.Gemelli

Roma, Italy