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