A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
Bristol-Myers Squibb
154 participants
Nov 15, 2023
OBSERVATIONAL
Conditions
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 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).
Eligibility
Inclusion Criteria4
- 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 Criteria2
- 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
Interventions
Maintenance therapy according to the approved label
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06073769