Ireland
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Recruiting Observational

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

NCT05772559 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-05-31
Last updated
2024-06-26

Condition(s) studied

Acute Myeloid LeukemiaGenetic Predisposition to Disease

Investigational drug(s) / intervention(s)

Collection of blood sample of bone marrow (cohort 1)Collection of blood sample of bone marrow (cohort 2 and 3)

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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
25 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS) — Up to 5 years

Trial sites (28)

FacilityCityRegionStatus
CHU Amiens Picardie site Sud Amiens France Recruiting
CHU Angers Angers France Recruiting
Hopital Minjoz Besançon France Recruiting
CHU Pellegrin Bordeaux France Recruiting
CHRU Morvan Brest France Recruiting
CHU Caen Caen France Recruiting
CHU Estaing Clermont-Ferrand France Recruiting
CHU Francois Mitterand Dijon France Recruiting
CHU Grenoble Grenoble France Recruiting
CHU de la Réunion La Réunion France Recruiting
Hopital Jeanne de Flandre - CHRU Lille France Recruiting
CHU Limoges Limoges France Recruiting
HCL Lyon Lyon France Recruiting
Hôpital d'Enfants de la Timone Marseille France Recruiting
CHU Montpellier Montpellier France Recruiting
CHRU Nancy- Hopitaux de Brabois Nancy France Recruiting
CHU Nantes Nantes France Recruiting
CHU Nice Nice France Recruiting
Hopital Robert Debré Paris France Recruiting
Hopital Trousseau Paris France Recruiting
CHU Poitiers Poitiers France Recruiting
Hopital Américain Reims France Recruiting
CHU Hopital Sud Rennes France Recruiting
CHU Rouen Rouen France Recruiting
CHU Saint Etienne Saint-Etienne France Recruiting
Hopital Hautepierre Strasbourg France Recruiting
CHU Toulouse Toulouse France Recruiting
CHRU Tours Tours France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05772559 on ClinicalTrials.gov ↗ ← All trials in France