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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-07-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adult relapsed or refractory B Cell ALL

Adult patients whose B Cell ALL has occurred again after the last treatment or patients who never responded to prior treatment

Inotuzumab Ozogamicin

Intervention Type DRUG

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

Interventions

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Inotuzumab Ozogamicin

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

Intervention Type DRUG

Other Intervention Names

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Besponsa Inonza

Eligibility Criteria

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Inclusion Criteria

* Patients aged ≥18 years old at the initiation of InO treatment

* Patients with relapsed/refractory B-cell ALL
* Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive
* Ph+ patients who have failed treatment with at least 1 TKI