NCT05597085

A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

A Retrospective Analysis of Inotuzumab Ozogamicin (InO) Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment. This retrospective Study enroll adult patients who: * were CD22 positive (a molecule in the body that stops the over activity of the immune system) * Received only InO for the treatment of B-cell ALL that occurred again after the last treatment * were Philadelphia chromosome positive (which occurs because of changes in genes) * failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division). The patient data except their personal details are collected from a hospital based electronic medical record in India. In this study the effectiveness and safety of InO will be studied after it was released to the market. To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India: * in whom the disease occurred again * or those who never showed any improvement to earlier treatments * now being treated with InO alone Around 55 patients who have taken InO are likely to be enrolled in the study. Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.

Conditions

• Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Inotuzumab Ozogamicin	Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL

Timeline

• Start date: 2023-03-08
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-10-27
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

5 sites across 1 country: India

Regulatory

• FDA-regulated drug study