Effectiveness and Safety of ONUREG (Oral Azacitidine) in... | NCT07458542

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

NCT07458542

Sponsor

Bristol-Myers Squibb

Status

Active, not recruiting

Last Update Posted

Mar 9, 2026Actual

Enrollment

44Actual

Phase

Not provided

Conditions

Acute Myeloid Leukemia (AML)

Interventions

Azacitidine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2025Actual

Primary Completion Date

Jan 9, 2026Actual

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Feb 25, 2026

First Submission Date that Met QC Criteria

Mar 5, 2026

First Posted Date

Mar 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2026

Last Update Posted Date

Mar 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Participants with acute myeloid leukemia (AML) receiving oral azacitidine	Drug: Azacitidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azacitidine	Drug	According to the product label	Group 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)		Up to 40 months
Incidence rates of adverse events (AEs)		Up to 40 months
Incidence rates of adverse events serious adverse events (SAEs)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bristol Myers Squibb	Bristol-Myers Squibb	Study Director

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides