Neoplasms

Blood and Lymph Conditions

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Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Genetic Predisposition to Disease

Disease Susceptibility

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Patients with acute myeloid leukemia at initial diagnosis or relapse, aged less than 25 years

Patients who undergo bone marrow aspirate as part of standard of care but without AML nor predisposition to develop AML, as controls

* 3 additional tubes of blood sample (cohort 1), at diagnosis and upon relapse if relapse occurs
* Bone marrow aspirate : 3 additional tubes (cohort 1), at diagnosis and upon relapse if relapse occurs

Collection of blood sample of bone marrow (cohort 1)

* 1 additional tube of blood sample (cohort 2 and 3 at inclusion)
* Bone marrow aspirate: 1 additional tube (cohort 2 and 3 at inclusion)

Collection of blood sample of bone marrow (cohort 2 and 3)

Arnaud PETIT, Pr

Matthieu RESCHE-RIGON, Pr

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.

Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies

Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies - ALARM3

Relapse is defined as:

Bone marrow blasts ≥ 5% and/or evidence of extramedullary disease

Event Free Survival (EFS) is defined as the time from start of chemotherapy to failure, relapse, or death which ever occurs first

Disease Free Survival (DFS) is defined as the time from remission status to relapse or death.

Number of mutations identified by Whole-Genome-Sequencing (WGS) as compared to Next-Generation Sequencing (NGS) in leukemic cells

Expression profile (transcriptome) of mesenchymal stem cells at AML diagnosis and relapse compared to age matched controls without AML

Engraftment rate of primary leukemic cells in Patient-derived xenografts (PDX) or other experimental models

Cumulative incidence of relapse according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

Event Free Survival according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

Disease-Free Survival (DFS) according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

Comparison of ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Event-Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Disease Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Comparison of mutational profile of patients with a predisposition syndrome compared to mutational profile of patients with AML at diagnosis and relapse

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies	NCT05772559	Acute Myeloid L... Genetic Predisp...	Collection of b... Collection of b...	- 25 Years	Assistance Publique - Hôpitaux de Paris
Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies	NCT05772559	Acute Myeloid L... Genetic Predisp...	Collection of b... Collection of b...	- 25 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for collection of blood sample of bone marrow (cohort 2 and 3)