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

NCT07458542 | Active Not Recruiting FDA Drug

• 1 other identifier: CA055-1055
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute myeloid leukemia (AML)

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS)

  Up to 40 months

Secondary Outcomes (13)

• 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)

  Up to 40 months

• Complete blood count (CBC) results

  Up to 40 months

• Bone marrow biopsy/aspiration test results

  Up to 40 months

Study Arms (1)

Group 1

Participants with acute myeloid leukemia (AML) receiving oral azacitidine

Drug: Azacitidine

Interventions

Azacitidine DRUG

According to the product label

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 9, 2026
• Study Start: December 9, 2025
• Primary Completion: January 9, 2026
• Study Completion: March 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)