Menu
Recruiting NCT05772559

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

— Observational Acute Myeloid Leukemia Genetic Predisposition to Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collection of blood sample of bone marrow (cohort 1), Collection of blood sample of bone marrow (cohort 2 and 3).
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Genetic Predisposition to Disease. Basic parameters: up to 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies - ALARM3

Overview

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.

Interventions

  • Other 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
  • Other 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)

Primary outcome measures

  • Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS) [Time frame: Up to 5 years]
Secondary outcome measures (12)
  • Cumulative incidence of relapse (CIR) from remission status. [Time frame: Up to 5 years]
  • Event Free Survival (EFS) [Time frame: Up to 5 years]
  • Disease Free Survival (DFS) [Time frame: Up to 5 years]
  • Number of mutations identified by WGS [Time frame: Up to 5 years]
  • Expression profile (transcriptome) of mesenchymal stem cells [Time frame: Up to 5 years]
  • Engraftment rate of primary leukemic cells [Time frame: Up to 5 years]
  • Matched rate of genetic mutational (or expression) profile between derived cells from experimental models to primary leukemic cells [Time frame: Up to 5 years]
  • Comparison of LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Time frame: Up to 5 years]
  • Cumulative incidence of relapse according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Time frame: Up to 5 years]
  • EFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Time frame: Up to 5 years]
  • DFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse [Time frame: Up to 5 years]
  • Ex vivo multidrug testing profile of leukemic primary blasts [Time frame: Up ot 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 28 centers
  • CHU Amiens Picardie site Sud — Amiens
  • CHU Angers — Angers
  • Hopital Minjoz — Besançon
  • CHU Pellegrin — Bordeaux
  • CHRU Morvan — Brest
  • CHU Caen — Caen
  • CHU Estaing — Clermont-Ferrand
  • CHU Francois Mitterand — Dijon
  • … and 20 more centers

Identifiers

NCT: NCT05772559 · APHP220571

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗