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New hope for AML patients: oral drug aims to keep remission going

NCT ID NCT07458542

Disease control Sponsor: Bristol-Myers Squibb 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study looks at how well and how safely oral azacitidine (ONUREG) works as maintenance therapy for Chinese adults with acute myeloid leukemia (AML) who are in remission after initial chemotherapy. The 44 participants cannot or choose not to have a stem cell transplant. Researchers will track how long patients stay cancer-free and monitor side effects.

What this could mean

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

Active substance
oral azacitidine (ONUREG)
What this could lead to
If successful, this could confirm that oral azacitidine helps keep AML in remission longer for patients who cannot have a stem cell transplant.
What could go wrong
This is a small, real-world study in Hong Kong with only 44 participants, so results may not apply broadly. Side effects like low blood counts or infections are possible.

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

44 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

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

The study population will include adults diagnosed with acute myeloid leukemia (AML) who received oral azacitidine after first complete response (CR) or complete response with incomplete blood recovery (CRi) in real-world settings and routine clinical practices in Hong Kong.

Ages

18 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: * Documented diagnosis of Acute Myeloid Leukemia (AML). * Achieved first complete response (CR) or complete response with incomplete blood recovery (CRi) following intensive induction chemotherapy. * Not able or unwilling to undergo Hematopoietic Stem Cell Transplantation (HSCT). * Received oral azacitidine as maintenance therapy after first CR or CRi following intensive induction chemotherapy in real-world settings (Note: CR/CRi status at oral azacitidine treatment initiation is left to the judgment of the local clinicians depending on the treatment response and the condition of the patient in routine clinical practices). * Age ≥ 18 years at the index date (oral azacitidine initiation date). Exclusion Criteria: • Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia (AML)

Contacts and locations

Locations

  • The University of Hong Kong

    Hong Kong, China

More trials for these conditions

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