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A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Sponsor: Bristol-Myers Squibb
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).
Official title: Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
154
Start Date
2023-11-15
Completion Date
2027-07-30
Last Updated
2024-11-06
Healthy Volunteers
No
Conditions
Interventions
Oral azacitidine
Maintenance therapy according to the approved label
Locations (2)
Local Institution - 0001
Seoul, South Korea
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea