Clinical trial · Observational
Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia
NCT07458542CI-TRIAL-00105020active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess real-world effectiveness and safety of oral azacitidine in adults diagnosed with acute myeloid leukemia (AML) in Hong Kong
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Participants with acute myeloid leukemia (AML) receiving oral azacitidine
- interventionNames
- Drug: Azacitidine
Primary outcomes (1)
- measure
- Relapse-free survival (RFS)
- timeFrame
- Up to 40 months
Secondary outcomes (13)
- measure
- Overall survival (OS)
- timeFrame
- Up to 40 months
- measure
- Incidence rates of adverse events (AEs)
- timeFrame
- Up to 40 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented diagnosis of Acute Myeloid Leukemia (AML). * Achieved first complete response (CR) or complete response with incomplete blood recovery (CRi) following intensive induction chemotherapy. * Not able or unwilling to undergo Hematopoietic Stem Cell Transplantation (HSCT). * Received oral azacitidine as maintenance therapy after first CR or CRi following intensive induction chemotherapy in real-world settings (Note: CR/CRi status at oral azacitidine treatment initiation is left to the judgment of the local clinicians depending on the treatment response and the condition of the patient in routine clinical practices). * Age ≥ 18 years at the index date (oral azacitidine initiation date). Exclusion Criteria: • Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).
References
Publications (0)
Data not yet available
No reference posted for this study.