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

NCT ID NCT04307134

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

108 people

The number who actually took part.

Started

Jul 2020

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL). 2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion criteria Patients meeting any of the following criteria will not be included in the study: 1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information. 2. Patients to whom BESPONSA® is contraindicated as per the local labeling. \-

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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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