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NCT Number: NCT07458542

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Azacitidine

Drug

According to the product label

Primary outcomes

  1. Relapse-free survival (RFS)

    Time frame: Up to 40 months

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 40 months

  2. Incidence rates of adverse events (AEs)

    Time frame: Up to 40 months

  3. Incidence rates of adverse events serious adverse events (SAEs)

    Time frame: Up to 40 months

  4. Complete blood count (CBC) results

    Time frame: Up to 40 months

  5. Bone marrow biopsy/aspiration test results

    Time frame: Up to 40 months

  6. 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

  7. Oral azacitidine treatment duration

    Time frame: Up to 40 months

  8. Total number of days dosed with oral azacitidine

    Time frame: Up to 40 months

  9. Number of treatment cycles

    Time frame: Up to 40 months

  10. Total cumulative oral azacitidine dose

    Time frame: Up to 40 months

  11. Average daily dose of oral azacitidine

    Time frame: Up to 40 months

  12. Oral azacitidine dose intensity

    Time frame: Up to 40 months

  13. Oral azacitidine dose adjustments

    Time frame: Up to 40 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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