NCT02714790已完成不适用
Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta
A.O.U. Città della Salute e della Scienza0 个研究点目标入组 281 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 主要终点
- Response
研究概览
简要总结
Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. MRD results will be relate to treatment outcome and survival analysis variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)
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
- 19 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
- •Age > 18 years
- •Intensive chemotherapy as first line curative treatment
- •Observation period: March 2004 - September 2014
- •Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry performed at baseline
- •Written informed consent
排除标准
- •Diagnosis of Acute Promyelocytic Leukemia
- •Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry NOT performed at baseline
- •Patient ineligible to intensive chemotherapy
结局指标
主要结局
Response
时间窗: +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy
Complete remission after chemotherapy
次要结局
- Disease Free Survival(+28 days after End of induction chemotherapy -Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy - +30 days after Allogeneic Transplant - Date of Relapse for at least 1 year (up to 10 years))
- Overall Survival(Date of last follow-up for at least 1 year (up to 10 years) or Death)
- Cumulative Incidence of Relapse(Date of Allogeneic Transplant, Date of Relapse for at least 1 year (up to 10 years - assessed every 3 months), Date of last follow-up for at least 1 year (up to 10 years) or Death)
研究者
Ernesta Audisio
MD
A.O.U. Città della Salute e della Scienza
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