A Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Percentage of Participants Achieving Overall Survival (OS)
研究概览
简要总结
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece.
Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled.
Around 100 participants will be enrolled in the study in approximately 15 sites in Greece.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
- •Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.
排除标准
- •Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
结局指标
主要结局
Percentage of Participants Achieving Overall Survival (OS)
时间窗: Up to 30 Months
OS is defined as the time from treatment initiation to death from any cause.
次要结局
- Total Time of Treatment with Venetoclax Combination Therapy(Up to 30 Months)
- Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important(Up to 30 Months)
- Percentage of Participants Achieving Composite Complete Remission(Up to 30 Months)
- Time to Transfusion Independence(Up to 30 Months)
- Post Baseline RBC and Platelet Transfusion Independence Rate(Up to 30 Months)
- Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment(Up to 30 Months)
- Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment(Up to 30 Months)
- Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner(Up to 30 Months)
- Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs)(Up to 30 Months)
- Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other)(Up to 30 Months)
- Healthcare Resource Utilization as the Type of Laboratory Tests(Up to 30 Months)
- Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting(Up to 30 Months)
- Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other)(Up to 30 Months)
- Healthcare Resource Utilization as the Number of Laboratory Tests(Up to 30 Months)