A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral azacitidine.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
Overview
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).
Interventions
- Drug Oral azacitidine
Maintenance therapy according to the approved label
Primary outcome measures
- Number of participants with adverse events (AES) [Time frame: Up to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 2 centers
- Local Institution - 0001 — Seoul
- Novotech Laboratory Korea Co., Ltd. — Seoul
Identifiers
NCT: NCT06073769 · CA055-007