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Clinical trial Recruiting at 1 site Observational Ages 19 and up

Assessing the safety of oral azacitidine for Korean patients with acute myeloid leukemia

Official title: Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia

Run by Bristol-Myers Squibb · NCT06073769 · Data updated 2026-11-12

This study is testing how safe oral azacitidine is for Korean adults with acute myeloid leukemia who have gone into remission after chemotherapy.

More Acute Myeloid Leukemia trials

Quick facts

Study typeObservational
Ages19 Years and up
SexAll
Enrollment154 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionschemotherapy
Locations2 sites (Seoul and 1 other locations)
StatusRecruiting
StartedNovember 15, 2023
Main results expectedJuly 30, 2027
Study endsJuly 30, 2027
Registry record updatedNovember 6, 2024
Trial IDNCT06073769 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Korean adults aged 19 and older with AML who have achieved remission and are receiving oral azacitidine.

Probably not a fit

Patients who are prescribed oral azacitidine for unapproved therapeutic indications or have contraindications will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the real-world safety of oral azacitidine maintenance therapy in Korean patients diagnosed with acute myeloid leukemia (AML) who have achieved first complete remission or complete remission with incomplete blood count recovery after initial chemotherapy. Participants must be adults aged 19 or older and not eligible for hematopoietic stem cell transplantation. The study will register all patients receiving oral azacitidine within the first two years of its marketing authorization in Korea. The focus is on monitoring safety outcomes in this specific patient population.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety profile of oral azacitidine, potentially improving treatment strategies for AML patients.

How similar studies have gone: While this study focuses on a specific population and treatment, similar observational studies have shown promise in assessing the safety of therapies in real-world settings.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who receive oral azacitidine according to the approved label
* For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea
* Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety

Where it's running

  • Novotech Laboratory Korea Co., Ltd.
    Seoul, South Korea     Recruiting
  • Local Institution - 0001
    Seoul, South Korea     Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Acute Myeloid Leukemia 453Bristol-Myers Squibb 102
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.