Actively Recruiting

Age: 0 - 25Years
All Genders
ID05772559

Acute Myeloid Leukemia at Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing, and Mesenchymal Stem Cell Interaction Studies

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-06-26

500

Participants Needed

28

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Pediatric acute myeloid leukemias are serious diseases with a poor outlook and a high chance of relapse. This research aims to collect biological samples to study the genetic makeup of leukemic cells from children, teenagers, and young adults at diagnosis or relapse. The goal is to better understand the key genetic changes that cause resistance and may predict relapse risk. The study also explores bone marrow stem cells and tests how leukemic cells respond to multiple drugs outside the body. Participants include those under 25 years old with acute myeloid leukemia at first diagnosis or relapse, as well as patients with a genetic risk for leukemia or those undergoing bone marrow sampling without leukemia to serve as controls. Blood and bone marrow samples are collected, with multiple tubes taken at diagnosis and relapse for those with leukemia, and single samples for others. These samples are used for genetic sequencing, expression profiling, and drug testing. During the study, researchers will analyze the number of genetic mutations and other molecular features up to five years after sample collection. They will monitor relapse rates, survival without events, and disease-free survival. Other measurements include stem cell profiles, drug response patterns, and clearance of minimal residual disease. Participants may be followed for up to five years to assess these outcomes and better understand leukemia biology and treatment resistance.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0 to 25 years
  • Newly diagnosed de novo or secondary acute myeloid leukemia (AML)
  • Relapsed or refractory AML
  • Genetic predisposition to develop AML
  • Patients without hematological malignancy or AML genetic predisposition who undergo bone marrow aspirate as part of standard care
  • Signed informed consent from parents if under 18, or from the patient if 18 or older
Not Eligible

You will not qualify if you...

  • Refusal to participate
  • Diagnosis of chronic myeloid leukemia (CML)
  • Lack of health insurance (French social security)
  • Under legal protection (tutelle, curatelle, or sauvegarde de justice)
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 5 years

Participants provide blood and bone marrow samples at diagnosis, relapse, or inclusion depending on their cohort assignment. These samples are used for molecular profiling and multidrug testing studies.

1 to 3 visits depending on cohort and disease status

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored over time to assess disease progression, relapse incidence, survival outcomes, and molecular changes in leukemic cells.

Follow-up visits scheduled as part of routine care

Trial Site Locations

Total: 28 locations

1

CHU Amiens Picardie site Sud

Amiens, France

Actively Recruiting

2

CHU Angers

Angers, France

Actively Recruiting

3

Hopital Minjoz

Besançon, France

Actively Recruiting

4

CHU Pellegrin

Bordeaux, France

Actively Recruiting

5

CHRU Morvan

Brest, France

Actively Recruiting

6

CHU Caen

Caen, France

Actively Recruiting

7

CHU Estaing

Clermont-Ferrand, France

Actively Recruiting

8

CHU Francois Mitterand

Dijon, France

Actively Recruiting

9

CHU Grenoble

Grenoble, France

Actively Recruiting

10

CHU de la Réunion

La Réunion, France

Actively Recruiting

11

Hopital Jeanne de Flandre - CHRU

Lille, France

Actively Recruiting

12

CHU Limoges

Limoges, France

Actively Recruiting

13

HCL Lyon

Lyon, France

Actively Recruiting

14

Hôpital d'Enfants de la Timone

Marseille, France

Actively Recruiting

15

CHU Montpellier

Montpellier, France

Actively Recruiting

16

CHRU Nancy- Hopitaux de Brabois

Nancy, France

Actively Recruiting

17

CHU Nantes

Nantes, France

Actively Recruiting

18

CHU Nice

Nice, France

Actively Recruiting

19

Hopital Robert Debré

Paris, France

Actively Recruiting

20

Hopital Trousseau

Paris, France

Actively Recruiting

21

CHU Poitiers

Poitiers, France

Actively Recruiting

22

Hopital Américain

Reims, France

Actively Recruiting

23

CHU Hopital Sud

Rennes, France

Actively Recruiting

24

CHU Rouen

Rouen, France

Actively Recruiting

25

CHU Saint Etienne

Saint-Etienne, France

Actively Recruiting

26

Hopital Hautepierre

Strasbourg, France

Actively Recruiting

27

CHU Toulouse

Toulouse, France

Actively Recruiting

28

CHRU Tours

Tours, France

Actively Recruiting

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Research Team

A

Arnaud PETIT, Pr

J

Jérôme Lambert, Pr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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