Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date.
The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.
详细描述
NOT PROVIDED
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)
- •Initial management by intensive chemotherapy, hypomethylants or targeted therapies
排除标准
- •- Opposition expressed to research
结局指标
主要结局
Event-free survival (EFS)
时间窗: December 2010 to December 2020
次要结局
- - Complete remission rate (CR / CRp)(December 2010 to December 2020)
- -Prognostic impact on OS, CR, EFS, DFS and CIR of recurrent somatic mutations(December 2010 to December 2020)
- - Cumulative incidence of molecular relapse.(December 2010 to December 2020)
- - Cumulative incidence of relapse (CIR) +/- censored at allograft(December 2010 to December 2020)
- - Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant(December 2010 to December 2020)
- - Second complete remission rate, OS, EFS, DFS and CIR post-relapse(December 2010 to December 2020)
- - Interaction between mutations and MRD on OS, CR, EFS, DFS and CIR(December 2010 to December 2020)
- - Prognostic impact on OS, CR, EFS, DFS, CIR and post-relapse survival of using first-line GO and relapsing(December 2010 to December 2020)
