Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia

N/AActive Not RecruitingNCT07458542

Bristol-Myers Squibb44 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Myeloid Leukemia (AML)

Interventions

AzacitidineDRUG

According to the product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

The University of Hong Kong

Hong Kong, China

Outcomes

Primary Outcomes

Relapse-free survival (RFS)

Time frame: Up to 40 months

Secondary Outcomes

Overall survival (OS)

Time frame: Up to 40 months

Incidence rates of adverse events (AEs)

Time frame: Up to 40 months

Incidence rates of adverse events serious adverse events (SAEs)

Time frame: Up to 40 months

Complete blood count (CBC) results

Time frame: Up to 40 months

Bone marrow biopsy/aspiration test results

Time frame: Up to 40 months

Number of participants with abnormal extended serum chemistry panel results

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

Time frame: Up to 40 months

Oral azacitidine treatment duration

Time frame: Up to 40 months

Total number of days dosed with oral azacitidine

Time frame: Up to 40 months

Number of treatment cycles

Time frame: Up to 40 months

Total cumulative oral azacitidine dose

Data from ClinicalTrials.gov

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