Status:
RECRUITING
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
19+ years
Brief Summary
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06073769
Start Date
November 15 2023
End Date
July 30 2027
Last Update
November 6 2024
Active Locations (2)
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1
Local Institution - 0001
Seoul, South Korea, 06234
2
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea, 06234