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
Assistance Publique - Hôpitaux de Paris
500 participants
May 31, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- 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
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)
Locations(28)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05772559