A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
NCT06073769 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 154
Last updated 2024-11-06
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).
Conditions
Interventions
- DRUG
-
Oral azacitidine
Maintenance therapy according to the approved label
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-15
- Primary Completion
- 2027-07-30
- Completion
- 2027-07-30
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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