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百时美施贵宝Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia 44 真实世界证据
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临床试验NCT07458542是一项针对急性髓系白血病的观察研究试验，目前试验状态为进行中（不再招募）。试验始于2025年12月9日，计划招募44名患者。该研究由百时美施贵宝主导，预计于2026年3月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月9日。
简要概括
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
官方标题
Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia
疾病
急性髓系白血病其他研究标识符
- CA055-1055
NCT编号
实际开始日期
2025-12-09
最近更新发布
2026-03-09
预计完成日期
2026-03-31
计划入组人数
44
研究类型
观察研究
试验状态
进行中（不再招募）
关键词
Acute myeloid leukemia (AML)
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Group 1 Participants with acute myeloid leukemia (AML) receiving oral azacitidine | Azacitidine According to the product label |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Relapse-free survival (RFS) | Up to 40 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 | 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 | Up to 40 months |
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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).
• Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).
百时美施贵宝没有联系数据。
1 位于 1 个国家/地区的研究中心
The University of Hong Kong, Hong Kong, China