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

Plain-language summary

This is an observational study that examines outcomes in people who received Inotuzumab Ozogamicin for relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (a blood cancer). Adults aged 18 and older who were CD22-positive and started Inotuzumab Ozogamicin monotherapy within the defined dates were included. It is a non-interventional (observational) study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Pfizer

Intervention

Inotuzumab Ozogamicin

Start date

3/8/2023

Estimated completion

7/10/2023

Countries

India

Related genes

Locations

• Gurugram, India
• Thalassery, India
• New Delhi, India
• Hyderabad, India
• Kolkata, India

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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