Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies
ALARM3
1 other identifier
observational
500
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2033
June 26, 2024
June 1, 2024
10 years
March 6, 2023
June 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS)
Up to 5 years
Secondary Outcomes (23)
Cumulative incidence of relapse (CIR) from remission status.
Up to 5 years
Event Free Survival (EFS)
Up to 5 years
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
- +18 more secondary outcomes
Study Arms (3)
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
Interventions
* 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
* 1 additional tube of blood sample (cohort 2 and 3 at inclusion) * Bone marrow aspirate: 1 additional tube (cohort 2 and 3 at inclusion)
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
CHU Amiens Picardie site Sud
Amiens, France
CHU Angers
Angers, France
Hopital Minjoz
Besançon, France
CHU Pellegrin
Bordeaux, France
CHRU Morvan
Brest, France
CHU Caen
Caen, France
CHU Estaing
Clermont-Ferrand, France
CHU Francois Mitterand
Dijon, France
CHU Grenoble
Grenoble, France
CHU de la Réunion
La Réunion, France
Hopital Jeanne de Flandre - CHRU
Lille, France
CHU Limoges
Limoges, France
HCL Lyon
Lyon, France
Hôpital d'Enfants de la Timone
Marseille, France
CHU Montpellier
Montpellier, France
CHRU Nancy- Hopitaux de Brabois
Nancy, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
Hopital Robert Debré
Paris, France
Hopital Trousseau
Paris, France
CHU Poitiers
Poitiers, France
Hopital Américain
Reims, France
CHU Hopital Sud
Rennes, France
CHU Rouen
Rouen, France
CHU Saint Etienne
Saint-Etienne, France
Hopital Hautepierre
Strasbourg, France
CHU Toulouse
Toulouse, France
CHRU Tours
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 16, 2023
Study Start
May 31, 2023
Primary Completion (Estimated)
May 31, 2033
Study Completion (Estimated)
May 31, 2033
Last Updated
June 26, 2024
Record last verified: 2024-06