VILMA: Therapeutic Results in Acute Mieloblastic Leukemia in Patients Older Than 60 Years or Not Candidates for Intensive Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,910
- 试验地点
- 20
- 主要终点
- Response Rate
研究概览
简要总结
This is a retrospective study to analyze the therapeutic results and clinical evolution all patients diagnosed with AML and aged ≥ 60años or not candidates for chemotherapy intensive, treated according to the different schemes available, including supportive care or palliative.
详细描述
Approximately in 6 months, collect and review the retrospective data.
During this period, and in order to ensure an excellent quality of the collected data, perform constant monitoring and real-time data received in 2 phases:
- Monitoring "in situ" in the focal point: once the information is received before shall enter in the database, will be reviewed each case report data (CRD) for screening for inconsistencies and issue unresolved issues (queries) to sender data center. After entering the information in the database is carry out and resolve those queries that have arisen after consultation Data tables in order to locate inconsistencies or unavailable fields.
- Telephone Monitoring: data shall be verified through telephone consultations all centers to verify and update recruitment and monitoring patients . To ensure the completion, accuracy and data quality is monitored by telephone at least 30% of registered patients.
- Final statistical analysis (approximately 8 months from baseline).
- Publication of results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients aged ≥60 years, diagnosed of AML or not candidates to intensive chemotherapy
排除标准
- •No exclusion criteria
结局指标
主要结局
Response Rate
时间窗: 8 months
The main objective of this study is to retrospectively evaluate the therapeutic results in the LMA in all patients older than 60 years or not candidates for intensive chemotherapy in different stages of the disease, regardless of the treatment received, and even if they do not have received (support or palliative treatment, exclusively
次要结局
未报告次要终点