CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Inotuzumab Ozogamicindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05597085
NCT05597085N/ACompleted

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

Pfizer·observational·Posted Oct 27, 2022·Updated Feb 4, 2025

In Brief

An observational study evaluating Inotuzumab Ozogamicin for Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia. Completed, enrolled 32 participants across 5 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 27, 2022
Enrollment StartMar 8, 2023
Primary CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.7 years ago

Interventions

Inotuzumab Ozogamicindrug

Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL