Acute Myeloid Leukemia (AML)NCT07458542
Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia (AML), run by Bristol-Myers Squibb at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Azacitidine
- Type of treatment
- Pill or oral medicine
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Azacitidine
- Keywords
- Acute myeloid leukemia (AML)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants with acute myeloid leukemia (AML) receiving oral azacitidine Receives: Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
Measured: Up to 40 months
Secondary outcomes (13)
Overall survival (OS)
Measured: Up to 40 months
Incidence rates of adverse events (AEs)
Measured: Up to 40 months
Incidence rates of adverse events serious adverse events (SAEs)
Measured: Up to 40 months
Complete blood count (CBC) results
Measured: Up to 40 months
Bone marrow biopsy/aspiration test results
Measured: Up to 40 months
Number of participants with abnormal extended serum chemistry panel results
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
Measured: Up to 40 months
Oral azacitidine treatment duration
Measured: Up to 40 months
Total number of days dosed with oral azacitidine
Measured: Up to 40 months
Number of treatment cycles
Measured: Up to 40 months
Total cumulative oral azacitidine dose
Measured: Up to 40 months
Average daily dose of oral azacitidine
Measured: Up to 40 months
Oral azacitidine dose intensity
Measured: Up to 40 months
Oral azacitidine dose adjustments
Measured: Up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start9 Dec 2025
- Primary completion9 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458542
- Sponsor's protocol ID
- CA055-1055
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07458542
- Acronym / sponsor ID
- CA055-1055
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia (AML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: AzacitidineParticipants with acute myeloid leukemia (AML) receiving oral azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAccording to the product label | Drug | Group 1 |
Primary outcome
Relapse-free survival (RFS)
Time frame: Up to 40 months
13 secondary outcomes
Overall survival (OS)
Time frame: Up to 40 months
Incidence rates of adverse events (AEs)
Time frame: Up to 40 months
Incidence rates of adverse events serious adverse events (SAEs)
Time frame: Up to 40 months
Complete blood count (CBC) results
Time frame: Up to 40 months
Bone marrow biopsy/aspiration test results
Time frame: Up to 40 months
Number of participants with abnormal extended serum chemistry panel results
Time frame: Up to 40 months
Oral azacitidine treatment duration
Time frame: Up to 40 months
Total number of days dosed with oral azacitidine
Time frame: Up to 40 months
Number of treatment cycles
Time frame: Up to 40 months
Total cumulative oral azacitidine dose
Time frame: Up to 40 months
Average daily dose of oral azacitidine
Time frame: Up to 40 months
Oral azacitidine dose intensity
Time frame: Up to 40 months
Oral azacitidine dose adjustments
Time frame: Up to 40 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML), run by Bristol-Myers Squibb at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: Up to 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.