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BESPONSA safety tracked in over 400 leukemia patients

NCT ID NCT05923112

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the safety of the drug BESPONSA in 421 people with a type of blood cancer called acute lymphocytic leukemia that had come back or stopped responding to treatment. All participants received BESPONSA as prescribed by their doctor. Researchers tracked side effects, especially liver problems, low blood cell counts, infections, and bleeding, for up to a year after starting the drug.

What this could mean

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

Active substance
BESPONSA (inotuzumab ozogamicin)
What this could lead to
If successful, this study could confirm the safety profile of BESPONSA for treating relapsed or refractory acute lymphocytic leukemia.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove effectiveness. Results may not apply outside Japan.

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

421 people

The number who actually took part.

Started

Jul 2018

Finished

Sep 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

All patients who received BESPONSA

Ages

0 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: * All patients prescribed BESPONSA Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphocytic leukemia

Contacts and locations

Locations

  • Pfizer

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.