A Center-Based Chart Review Study to Assess Treatment Outcomes of Venetoclax for the Treatment of Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.
Data from up to 700 participants will be collected. No participants will be enrolled in this study.
Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.
There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant received a diagnosis for acute myeloid leukemia (AML).
- •The participant was initiated on the studied line of therapy for previously untreated AML, as noted in the protocol.
- •The participant was treated with the studied line of therapy at least 28 days prior to date of data collection.
- •Information on the participant's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards.
排除标准
- •The participant received the studied line of therapy as part of a clinical trial.
- •Participant received prior lines of therapy for AML.
- •The participant has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of what is noted in the protocol.
结局指标
主要结局
Event-free survival (EFS)
时间窗: Up to 10 Months
EFS will be measured as the number of days between the initiation of the studied line of therapy and disease progression, or refractory disease, or death.
Duration of Response (DoR)
时间窗: Up to 10 Months
DoR is is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi), complete remission with partial hematologic recovery (CRh), morphologic leukemia-free state (MLFS); in days.
Overall Survival (OS)
时间窗: Up to 10 Months
OS will be measured as the number of days between the initiation of the studied line of therapy and death.
Percentage of Participants with Transfusion Independence (TI)
时间窗: Up to 10 Months
TI from initiation of the studied line of therapy until disease progression, refractory disease, relapse, or switch to a new line of therapy.
Percentage of Participants Achieving Best Overall Response
时间窗: Up to 10 Months
Physician-reported best response achieved from initiation of the studied line of therapy until the earliest of disease progression, refractory disease, relapse, switch to a new line of therapy, or end of follow-up or death.
次要结局
- Number of Participants with Healthcare Resource Utilization (HRU)(Up to 10 Months)