Trials / Recruiting
RecruitingNCT06073769
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 154 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Oral azacitidine | Maintenance therapy according to the approved label |
Timeline
- Start date
- 2023-11-15
- Primary completion
- 2027-07-30
- Completion
- 2027-07-30
- First posted
- 2023-10-10
- Last updated
- 2024-11-06
Locations
2 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06073769. Inclusion in this directory is not an endorsement.