A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia

The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Oral Azacitidine

Drug

Maintenance therapy according to the approved label

Primary outcomes

Number of participants with adverse events (AES)

Time frame: Up to 12 months

The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Oct 10, 2023
Registry last updated: Nov 6, 2024

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.

Published trials that share one or more normalized conditions with this study.

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