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

Recruiting

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

• Registration Number: NCT06025682
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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).

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Status Verified: 2024-04
• Study Start: 2024-04-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	5 months	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).

Trial Locations

Locations (1)

UOC Ematologia Fondazione Policlinico Universitario A.Gemelli; 🇮🇹 Roma, Italy