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

Status: Enrolling

Conditions: Genetic Predisposition to Disease; Acute Myeloid Leukemia

Treatments: Other: Collection of blood sample of bone marrow (cohort 2 and 3); Other: Collection of blood sample of bone marrow (cohort 1)

Study type: Observational

Funder types: Other

Identifiers

NCT05772559

APHP220571

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Cohort 1 : Patients with acute myeloid leukemia

Description:

Patients with acute myeloid leukemia at initial diagnosis or relapse, aged less than 25 years

Treatment:

Other: Collection of blood sample of bone marrow (cohort 1)

Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemia

Treatment:

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

Cohort 3 : Patients who undergo bone marrow aspirate

Description:

Patients who undergo bone marrow aspirate as part of standard of care but without AML nor predisposition to develop AML, as controls

Treatment:

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