NCT05772559招募中不适用
Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies - ALARM3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 28
- 主要终点
- Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS)
研究概览
简要总结
Pediatric acute myeloid leukemias are disease with poor prognosis (overall survival of 60-75%) and high relapse rate of 35-45% require further understanding of the underlying biological mechanisms.
The main objective of this study is to establish a biological collection to evaluate the genomic profiling of leukemic cells from primary blasts at diagnosis and/or relapse to improve identification of the main genetic hits involved in resistance and could predict a high risk of relapse. Other objectives include the study of bone marrow mesenchymal stem cells and ex vivo drug testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0-25 years old
- •Newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML) or
- •Relapsed or refractory AML or
- •Patients with genetic predisposition to develop AML or
- •Patients without haematological malignancy nor AML genetic predisposition syndrome who undergo bone marrow aspirate as part of standard of care
- •Signed informed consent of parents for patients aged less than 18 years old or signed informed consent of the patient for patients aged 18 and over.
排除标准
- •Refuse to participate
- •Chronic myeloid leukemia (CML)
- •Lack of health insurance (French social security)
- •Under protection (tutelle, curatelle or sauvegarde de justice)
- •Pregnancy or breastfeeding
结局指标
主要结局
Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS)
时间窗: Up to 5 years
次要结局
- Disease Free Survival (DFS)(Up to 5 years)
- Number of mutations identified by WGS(Up to 5 years)
- Expression profile (transcriptome) of mesenchymal stem cells(Up to 5 years)
- EFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse(Up to 5 years)
- Engraftment rate of primary leukemic cells(Up to 5 years)
- Comparison of LSC signature profile of leukemic primary blasts at diagnosis and at relapse(Up to 5 years)
- Cumulative incidence of relapse according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse(Up to 5 years)
- EFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse(Up to 5 years)
- Percentage of MRD clearance(Up to 5 years)
- EFS according to MRD clearance(Up to 5 years)
- DFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse(Up to 5 years)
- Ex vivo multidrug testing profile of leukemic primary blasts(Up ot 5 years)
- Cumulative incidence of relapse according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse(Up to 5 years)
- DFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse(Up to 5 years)
- Mutational profile of patients(Up ot 5 years)
- DFS according to MRD clearance(Up to 5 years)
- Cumulative incidence of relapse according to MRD clearance(Up to 5 years)
- Cumulative incidence of relapse (CIR) from remission status.(Up to 5 years)
- Event Free Survival (EFS)(Up to 5 years)
- Matched rate of genetic mutational (or expression) profile between derived cells from experimental models to primary leukemic cells(Up to 5 years)
研究者
研究点 (28)
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