Checks safety of oral azacitidine in Korean patients with acute myeloid leukemia
Studies safety of oral azacitidine maintenance in Korean adults with leukemia in remission.
Plain-language title generated from the registry record
Registry title: A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Key facts
- Where
- Seoul, South KoreaSee the 2 sites
Where in South Korea
- Novotech Laboratory Korea Co., Ltd.Seoul, South KoreaTaking people
- SeoulSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06073769
- Record updated
- 6 November 2024
- Original description
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).Read full original descriptionShow less
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
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).
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 for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety; Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea.