Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
UOC Ematologia Fondazione Policlinico Universitario A.Gemelli
RECRUITING
Roma
Contact Information
Primary
Paola Fazi
p.fazi@gimema.it
0670390528
Backup
Enrico Crea
e.crea@gimema.it
0670390514
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2025-01
Participants
Target number of participants: 158
Related Therapeutic Areas
Sponsors
Leads: Gruppo Italiano Malattie EMatologiche dell'Adulto