Observational study on infections in patients with B-cell acute lymphoblastic leukemia 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)
This study looks at how often infections happen in adults with B-cell acute lymphoblastic leukemia who have been treated with a drug called inotuzumab-ozogamicin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Drugs / interventions | inotuzumab, inotuzuumab |
| Locations | 1 site (Roma) |
| Trial ID | NCT06025682 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the incidence of infectious complications, including bacterial, fungal, and viral infections, in adult patients with B-cell acute lymphoblastic leukemia (ALL) who have been treated with inotuzumab-ozogamicin (INO). The study will collect retrospective data from approximately 20 hematologic centers over the past five years, focusing on patients who are not part of interventional clinical trials. By analyzing the outcomes of these patients, the study seeks to provide insights into the safety and complications associated with INO treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old with relapsed or refractory CD22 positive B-ALL treated with INO.
Not a fit: Patients currently enrolled in interventional clinical trials involving INO will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of infection risks in ALL patients treated with INO, potentially leading to improved management strategies.
How similar studies have performed: While similar studies on infectious complications in leukemia treatments exist, this specific observational approach focusing on INO is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma
- UOC Ematologia Fondazione Policlinico Universitario A.Gemelli — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Livio Pagano — Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.