A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
- Registration Number
- NCT06073769
- Lead Sponsor
- Bristol-Myers Squibb
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants receiving oral azacitidine maintenance therapy Oral azacitidine -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AES) Up to 12 months The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Local Institution - 0001
🇰🇷Seoul, Korea, Republic of
Novotech Laboratory Korea Co., Ltd.
🇰🇷Seoul, Korea, Republic of