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NCT06025682 Clinical Trial

Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO

Acute Lymphoblastic Leukemia Clinical Trial

— INO-FIRST  

Official title:
Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06025682
Other study ID # INF0123
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 4, 2024
Est. completion date January 2025

Study information
Verified date April 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).

Recruitment information / eligibility
Status Recruiting
Enrollment 158
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy UOC Ematologia Fondazione Policlinico Universitario A.Gemelli Roma

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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