Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 210
- 试验地点
- 40
- 主要终点
- 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 induction chemotherapy in Canada.
Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). 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 induction chemotherapy will be enrolled. Around 200 participants will be enrolled in the study in approximately 15-20 sites in Canada.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 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 36 months.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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
- Diagnosis of Acute Myeloid Leukemia (AML).
- Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice.
- Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.
排除标准
- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
研究组 & 干预措施
Venetoclax Participants
Participants treated with Venetoclax in accordance with approved local label.
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 36 Months
OS as defined by number of days from start of treatment to the completion of treatment or death from any cause.
次要结局
- Number of Participants with Transfusions(Up to 36 Months)
- Number of Participants with Change in Venetoclax Dose(Up to 36 Months)
- Number of Hospital Admission(Up to 36 Months)
- Number of Participants with Change in use of Antiinfectives(Up to 36 Months)
- Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk(Up to 36 Months)
- Occurrence of any Adverse Events(Up to 36 Months)
- Change in Composite Complete Remission Rate(Up to 36 Months)
- Event-Free Survival (EFS)(Up to 36 Months)
- Number of Participants with Change in Other Medications(Up to 36 Months)
- Venetoclax Administration Setting(Up to 36 Months)
- Percentage of Participants with Presence Transfusion Independence(Up to 36 Months)
研究者
研究点 (40)
标识符
- NCT 编号
- NCT05424562
- 其他研究编号
- P23-363
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (上个月)
- 研究完成日期
- (上个月)
- 最近核实
- (11个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否