Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia

March 5, 2026 updated by: Bristol-Myers Squibb
The purpose of this study is to assess real-world effectiveness and safety of oral azacitidine in adults diagnosed with acute myeloid leukemia (AML) in Hong Kong

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Participants with acute myeloid leukemia (AML) receiving oral azacitidine
Drug: Azacitidine
According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival (RFS)
Time Frame: Up to 40 months
Up to 40 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 40 months
Up to 40 months
Incidence rates of adverse events (AEs)
Time Frame: Up to 40 months
Up to 40 months
Incidence rates of adverse events serious adverse events (SAEs)
Time Frame: Up to 40 months
Up to 40 months
Complete blood count (CBC) results
Time Frame: Up to 40 months
Up to 40 months
Bone marrow biopsy/aspiration test results
Time Frame: Up to 40 months
Up to 40 months
Number of participants with abnormal extended serum chemistry panel results
Time Frame: Up to 40 months
Extended serum chemistry panel: sodium, potassium, chloride, calcium, phosphorus, blood urea nitrogen, creatinine, glucose, albumin, total protein, alkaline phosphatase, total bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, and uric acid
Up to 40 months
Oral azacitidine treatment duration
Time Frame: Up to 40 months
Up to 40 months
Total number of days dosed with oral azacitidine
Time Frame: Up to 40 months
Up to 40 months
Number of treatment cycles
Time Frame: Up to 40 months
Up to 40 months
Total cumulative oral azacitidine dose
Time Frame: Up to 40 months
Up to 40 months
Average daily dose of oral azacitidine
Time Frame: Up to 40 months
Up to 40 months
Oral azacitidine dose intensity
Time Frame: Up to 40 months
Up to 40 months
Oral azacitidine dose adjustments
Time Frame: Up to 40 months
Up to 40 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Actual)

January 9, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA055-1055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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