Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO
INO-FIRST
Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)
1 other identifier
observational
158
1 country
1
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedStudy Start
First participant enrolled
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedApril 11, 2024
April 1, 2024
9 months
August 29, 2023
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)
To estimate the rate of clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).
5 months
Eligibility Criteria
Adult patients with relapsed/refractory CD22 positive acute lymphoblastic leukemia treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
You may qualify if:
- 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.
You may not qualify if:
- Patients treated with INO in interventional clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UOC Ematologia Fondazione Policlinico Universitario A.Gemelli
Roma, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Livio Pagano
Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2023
First Posted
September 6, 2023
Study Start
April 4, 2024
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
April 11, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share