BESPONSA under the microscope: korean study tracks Real-World safety

NCT ID NCT04307134

Completed Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study monitored the safety and effectiveness of BESPONSA (inotuzumab ozogamicin) in 108 Korean adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug is already approved in Korea, and this post-marketing surveillance was required to check for any problems in everyday use. Researchers tracked side effects and how well the drug worked, focusing on serious events like liver damage (VOD/SOS).

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: inotuzumab ozogamicin (BESPONSA)
What this could lead to: If results confirm its safety profile, it supports BESPONSA as a treatment option for relapsed/refractory B-cell ALL in routine practice.
What could go wrong: This is a post-marketing surveillance study, not a new clinical trial. It mainly tracks known side effects like liver problems (VOD/SOS) and does not test a new approach.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm precursor B-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEMATOLOGIC MALIGNANCY

Contacts and locations

Locations

Pfizer

Seoul, South Korea

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