Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO
Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Aug 29, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how often patients with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) develop infections after receiving a specific treatment known as inotuzumab-ozogamicin (INO). Researchers want to understand how common infections—like bacterial, viral, and fungal—are for patients during the 60 days after they finish their treatment. This study is important because it could help doctors better manage and support patients by knowing what risks they may face.
To participate in this study, you need to be an adult over 18 years old and have a specific type of B-ALL, especially if your cancer has come back or hasn't responded to other treatments. If you are interested and meet the criteria, you will be asked to provide consent to take part. Participants will have their health monitored to track any infections and outcomes following the treatment. This information may ultimately lead to improving care for future patients with similar conditions.
Gender
ALL
Eligibility criteria
- 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.
About Gruppo Italiano Malattie Ematologiche Dell'adulto
The Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) is a prestigious Italian research group dedicated to advancing the understanding and treatment of adult hematological diseases. Comprising a network of leading hematologists and clinical researchers, GIMEMA conducts innovative clinical trials aimed at improving patient outcomes through the development of novel therapeutic strategies and evidence-based practices. With a strong emphasis on collaboration and scientific rigor, GIMEMA plays a pivotal role in enhancing the landscape of hematology both in Italy and internationally, contributing significantly to the global body of research and clinical knowledge in this critical field.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Livio Pagano
Principal Investigator
Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported