NCT06025682

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 158 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Acute Lymphoblastic Leukemia
• Infections
• Bacterial Infections
• Viral Infection
• Fungal Infection
• Acute Lymphoblastic Leukemia, Adult
• Acute Lymphoblastic Leukemia, in Relapse

Timeline

• Start date: 2024-04-04
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-09-06
• Last updated: 2024-04-11

Locations

1 site across 1 country: Italy