Trial Title:
Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies
NCT ID:
NCT05772559
Condition:
Acute Myeloid Leukemia
Genetic Predisposition to Disease
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Genetic Predisposition to Disease
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Collection of blood sample of bone marrow (cohort 1)
Description:
- 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
Arm group label:
Cohort 1 : Patients with acute myeloid leukemia
Intervention type:
Other
Intervention name:
Collection of blood sample of bone marrow (cohort 2 and 3)
Description:
- 1 additional tube of blood sample (cohort 2 and 3 at inclusion)
- Bone marrow aspirate: 1 additional tube (cohort 2 and 3 at inclusion)
Arm group label:
Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemia
Arm group label:
Cohort 3 : Patients who undergo bone marrow aspirate
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Amiens Picardie site Sud
Address:
City:
Amiens
Country:
France
Status:
Recruiting
Contact:
Last name:
Camille Leglise, MD
Facility:
Name:
CHU Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
Isabelle Pellier, MD
Facility:
Name:
Hopital Minjoz
Address:
City:
Besançon
Country:
France
Status:
Recruiting
Contact:
Last name:
Nathalie Cheikh, MD
Facility:
Name:
CHU Pellegrin
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphane Ducassou, MD
Facility:
Name:
CHRU Morvan
Address:
City:
Brest
Country:
France
Status:
Recruiting
Contact:
Last name:
Liana Carausu, MD
Facility:
Name:
CHU Caen
Address:
City:
Caen
Country:
France
Status:
Recruiting
Contact:
Last name:
Jérémie Rouger, MD
Facility:
Name:
CHU Estaing
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Recruiting
Contact:
Last name:
Justyna Kanold, MD
Facility:
Name:
CHU Francois Mitterand
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire Desplante, MD
Facility:
Name:
CHU Grenoble
Address:
City:
Grenoble
Country:
France
Status:
Recruiting
Contact:
Last name:
Corinne Armari Alla, MD
Facility:
Name:
CHU de la Réunion
Address:
City:
La Réunion
Country:
France
Status:
Recruiting
Contact:
Last name:
Yves Reguerre, MD
Facility:
Name:
Hopital Jeanne de Flandre - CHRU
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Brigitte Nelken, MD
Facility:
Name:
CHU Limoges
Address:
City:
Limoges
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas Louvray, MD
Facility:
Name:
HCL Lyon
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Contact:
Last name:
Cécile Renard, MD
Facility:
Name:
Hôpital d'Enfants de la Timone
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Paul Saultier, MD
Facility:
Name:
CHU Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphanie Haouy, MD
Facility:
Name:
CHRU Nancy- Hopitaux de Brabois
Address:
City:
Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
Marion Lubnau, MD
Facility:
Name:
CHU Nantes
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Contact:
Last name:
Fanny Rialland, MD
Facility:
Name:
CHU Nice
Address:
City:
Nice
Country:
France
Status:
Recruiting
Contact:
Last name:
Marilyne Poirée, MD
Facility:
Name:
Hopital Robert Debré
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Marion Strullu, MD
Facility:
Name:
Hopital Trousseau
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Arnaud Petit, MD PhD
Facility:
Name:
CHU Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Recruiting
Contact:
Last name:
Frédéric Millot, MD
Facility:
Name:
Hopital Américain
Address:
City:
Reims
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire Pluchart, MD
Facility:
Name:
CHU Hopital Sud
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Virginie Gandemer, MD
Facility:
Name:
CHU Rouen
Address:
City:
Rouen
Country:
France
Status:
Recruiting
Contact:
Last name:
Nimrod Buchbinde, MD
Facility:
Name:
CHU Saint Etienne
Address:
City:
Saint-Étienne
Country:
France
Status:
Recruiting
Contact:
Last name:
Sandrine Thouvenin-Doulet, MD
Facility:
Name:
Hopital Hautepierre
Address:
City:
Strasbourg
Country:
France
Status:
Recruiting
Contact:
Last name:
Catherine Paillard, MD
Facility:
Name:
CHU Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Marlène Pasquet, MD
Facility:
Name:
CHRU Tours
Address:
City:
Tours
Country:
France
Status:
Recruiting
Contact:
Last name:
Julien Lejeune, MD
Start date:
May 31, 2023
Completion date:
May 31, 2033
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772559
