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

Pfizer

Status: Completed

Conditions: Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Treatments: Drug: Inotuzumab Ozogamicin

Study type: Observational

Funder types: Industry

Identifiers

NCT05597085

NCT05597085 (Registry Identifier)

B1931043

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy

Trial design

32 participants in 1 patient group

Adult relapsed or refractory B Cell ALL

Description:

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

Treatment:

Drug: Inotuzumab Ozogamicin