Assessing the safety of oral azacitidine for Korean patients with acute myeloid leukemia
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
This study is testing how safe oral azacitidine is for Korean adults with acute myeloid leukemia who have gone into remission after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 154 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06073769 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world safety of oral azacitidine maintenance therapy in Korean patients diagnosed with acute myeloid leukemia (AML) who have achieved first complete remission or complete remission with incomplete blood count recovery after initial chemotherapy. Participants must be adults aged 19 or older and not eligible for hematopoietic stem cell transplantation. The study will register all patients receiving oral azacitidine within the first two years of its marketing authorization in Korea. The focus is on monitoring safety outcomes in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are Korean adults aged 19 and older with AML who have achieved remission and are receiving oral azacitidine.
Not a fit: Patients who are prescribed oral azacitidine for unapproved therapeutic indications or have contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of oral azacitidine, potentially improving treatment strategies for AML patients.
How similar studies have performed: While this study focuses on a specific population and treatment, similar observational studies have shown promise in assessing the safety of therapies in real-world settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 1 other locations
- Local Institution - 0001 — Seoul, South Korea (Terminated)
- Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.