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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 : Patients with acute myeloid leukemia | Patients with acute myeloid leukemia at initial diagnosis or relapse, aged less than 25 years |
| |
| Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemia |
| ||
| Cohort 3 : Patients who undergo bone marrow aspirate | Patients who undergo bone marrow aspirate as part of standard of care but without AML nor predisposition to develop AML, as controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of blood sample of bone marrow (cohort 1) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of relapse (CIR) from remission status. | Relapse is defined as: Bone marrow blasts ≥ 5% and/or evidence of extramedullary disease | Up to 5 years |
| Event Free Survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Children or young adult with 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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud PETIT, Pr | Contact | +33 1 44 73 53 14 | arnaud.petit@aphp.fr | |
| Jérôme Lambert, Pr | Contact | 142499742 | +33 | jerome.lambert@u-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie site Sud | Recruiting | Amiens | France |
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| Collection of blood sample of bone marrow (cohort 2 and 3) | Other |
|
|
Event Free Survival (EFS) is defined as the time from start of chemotherapy to failure, relapse, or death which ever occurs first
| Up to 5 years |
| Disease Free Survival (DFS) | Disease Free Survival (DFS) is defined as the time from remission status to relapse or death. | Up to 5 years |
| Number of mutations identified by WGS | Number of mutations identified by Whole-Genome-Sequencing (WGS) as compared to Next-Generation Sequencing (NGS) in leukemic cells | Up to 5 years |
| Expression profile (transcriptome) of mesenchymal stem cells | Expression profile (transcriptome) of mesenchymal stem cells at AML diagnosis and relapse compared to age matched controls without AML | Up to 5 years |
| Engraftment rate of primary leukemic cells | Engraftment rate of primary leukemic cells in Patient-derived xenografts (PDX) or other experimental models | 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 |
| 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 | Cumulative incidence of relapse according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse | Up to 5 years |
| EFS according to 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 | Up to 5 years |
| DFS according to 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 | Up to 5 years |
| Ex vivo multidrug testing profile of leukemic primary blasts | Comparison of ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse | 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 |
| EFS according to 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 | Up to 5 years |
| DFS 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 | Up to 5 years |
| Mutational profile of patients | Comparison of mutational profile of patients with a predisposition syndrome compared to mutational profile of patients with AML at diagnosis and relapse | Up ot 5 years |
| Percentage of MRD clearance | MRD clearance is defined as MRD below 10-3 Evaluated by flow cytometry and high sensitivity NGS (defined as MRD below 10-4) after each chemotherapy course | Up to 5 years |
| Cumulative incidence of relapse according to MRD clearance | Evaluated by flow cytometry at a sensitivity threshold of 10-3 | Up to 5 years |
| EFS according to MRD clearance | Evaluated by flow cytometry at a sensitivity threshold of 10-3 | Up to 5 years |
| DFS according to MRD clearance | Evaluated by flow cytometry at a sensitivity threshold of 10-3 | Up to 5 years |
| Cumulative incidence of relapse according to MRD clearance | Evaluated by high sensitivity NGS at a threshold of 10-4 | Up to 5 years |
| EFS according to MRD clearance | Evaluated by high sensitivity NGS at a threshold of 10-4 | Up to 5 years |
| DFS according to MRD clearance | Evaluated by high sensitivity NGS at a threshold of 10-4 | Up to 5 years |
| CHU Angers | Recruiting | Angers | France |
|
| Hopital Minjoz | Recruiting | Besançon | France |
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| CHU Pellegrin | Recruiting | Bordeaux | France |
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| CHRU Morvan | Recruiting | Brest | France |
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| CHU Caen | Recruiting | Caen | France |
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| CHU Estaing | Recruiting | Clermont-Ferrand | France |
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| CHU Francois Mitterand | Recruiting | Dijon | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| CHU de la Réunion | Recruiting | La Réunion | France |
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| Hopital Jeanne de Flandre - CHRU | Recruiting | Lille | France |
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| CHU Limoges | Recruiting | Limoges | France |
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| HCL Lyon | Recruiting | Lyon | France |
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| Hôpital d'Enfants de la Timone | Recruiting | Marseille | France |
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| CHU Montpellier | Recruiting | Montpellier | France |
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| CHRU Nancy- Hopitaux de Brabois | Recruiting | Nancy | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| CHU Nice | Recruiting | Nice | France |
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| Hopital Robert Debré | Recruiting | Paris | France |
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| Hopital Trousseau | Recruiting | Paris | France |
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| CHU Poitiers | Recruiting | Poitiers | France |
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| Hopital Américain | Recruiting | Reims | France |
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| CHU Hopital Sud | Recruiting | Rennes | France |
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| CHU Rouen | Recruiting | Rouen | France |
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| CHU Saint Etienne | Recruiting | Saint-Etienne | France |
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| Hopital Hautepierre | Recruiting | Strasbourg | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| CHRU Tours | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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