Acute Myeloid Leukemia (AML)
Conditions
Keywords
Acute myeloid leukemia (AML)
Brief summary
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
Interventions
DRUGAzacitidine
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS) | Up to 40 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 40 months | — |
| Incidence rates of adverse events (AEs) | Up to 40 months | — |
| Incidence rates of adverse events serious adverse events (SAEs) | Up to 40 months | — |
| Complete blood count (CBC) results | Up to 40 months | — |
| Bone marrow biopsy/aspiration test results | Up to 40 months | — |
| Number of participants with abnormal extended serum chemistry panel results | Up to 40 months | Extended serum chemistry panel: sodium, potassium, chloride, calcium, phosphorus, blood urea nitrogen, creatinine, glucose, albumin, total protein, alkaline phosphatase, total bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, and uric acid |
| Oral azacitidine treatment duration | Up to 40 months | — |
| Total number of days dosed with oral azacitidine | Up to 40 months | — |
| Number of treatment cycles | Up to 40 months | — |
| Total cumulative oral azacitidine dose | Up to 40 months | — |
| Average daily dose of oral azacitidine | Up to 40 months | — |
| Oral azacitidine dose intensity | Up to 40 months | — |
| Oral azacitidine dose adjustments | Up to 40 months | — |
Countries
China
Contacts
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed