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Acute Myeloid LeukemiaALARM3NCT05772559

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

An observational study of Acute Myeloid Leukemia and Genetic Predisposition to Disease, run by Assistance Publique - Hôpitaux de Paris at 28 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 25 years
What is being tested?
Collection of blood sample of bone marrow (cohort 1) and Collection of blood sample of bone marrow (cohort 2 and 3)
How many people
500 participants
Where
28 sitesFrance
Study dates
31 May 2023to 31 May 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: 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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arnaud PETIT, Pr contact

+33 1 44 73 53 14

arnaud.petit@aphp.fr

Jérôme Lambert, Pr contact

142499742 ext. +33

jerome.lambert@u-paris.fr

28 sites in 1 country

France28 sites, 28 recruiting

  • CHU Amiens Picardie site Sud

    Amiens

    Camille Leglise, MD

    Recruiting

  • CHU Angers

    Angers

    Isabelle Pellier, MD

    Recruiting

  • Hopital Minjoz

    Besançon

    Nathalie Cheikh, MD

    Recruiting

  • CHU Pellegrin

    Bordeaux

    Stéphane Ducassou, MD

    Recruiting

  • CHRU Morvan

    Brest

    Liana Carausu, MD

    Recruiting

  • CHU Caen

    Caen

    Jérémie Rouger, MD

    Recruiting

  • CHU Estaing

    Clermont-Ferrand

    Justyna Kanold, MD

    Recruiting

  • CHU Francois Mitterand

    Dijon

    Claire Desplante, MD

    Recruiting

  • CHU Grenoble

    Grenoble

    Corinne Armari Alla, MD

    Recruiting

  • CHU de la Réunion

    La Réunion

    Yves Reguerre, MD

    Recruiting

  • Hopital Jeanne de Flandre - CHRU

    Lille

    Brigitte Nelken, MD

    Recruiting

  • CHU Limoges

    Limoges

    Thomas Louvray, MD

    Recruiting

  • HCL Lyon

    Lyon

    Cécile Renard, MD

    Recruiting

  • Hôpital d'Enfants de la Timone

    Marseille

    Paul Saultier, MD

    Recruiting

  • CHU Montpellier

    Montpellier

    Stéphanie Haouy, MD

    Recruiting

  • CHRU Nancy- Hopitaux de Brabois

    Nancy

    Marion Lubnau, MD

    Recruiting

  • CHU Nantes

    Nantes

    Fanny Rialland, MD

    Recruiting

  • CHU Nice

    Nice

    Marilyne Poirée, MD

    Recruiting

  • Hopital Robert Debré

    Paris

    Marion Strullu, MD

    Recruiting

  • Hopital Trousseau

    Paris

    Arnaud Petit, MD PhD

    Recruiting

  • CHU Poitiers

    Poitiers

    Frédéric Millot, MD

    Recruiting

  • Hopital Américain

    Reims

    Claire Pluchart, MD

    Recruiting

  • CHU Hopital Sud

    Rennes

    Virginie Gandemer, MD

    Recruiting

  • CHU Rouen

    Rouen

    Nimrod Buchbinde, MD

    Recruiting

  • CHU Saint Etienne

    Saint-Etienne

    Sandrine Thouvenin-Doulet, MD

    Recruiting

  • Hopital Hautepierre

    Strasbourg

    Catherine Paillard, MD

    Recruiting

  • CHU Toulouse

    Toulouse

    Marlène Pasquet, MD

    Recruiting

  • CHRU Tours

    Tours

    Julien Lejeune, MD

    Recruiting

Other trials in France

About this study

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

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.

Being tested
Collection of blood sample of bone marrow (cohort 1), Collection of blood sample of bone marrow (cohort 2 and 3)
Medical subject headings
Leukemia, Myeloid, Acute, Genetic Predisposition to Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    • 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

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

    • 1 additional tube of blood sample (cohort 2 and 3 at inclusion)
    • Bone marrow aspirate: 1 additional tube (cohort 2 and 3 at inclusion)
Study groups in NCT05772559
Study groupRoleWhat they receive
Cohort 1 : Patients with acute myeloid leukemiaPatients with acute myeloid leukemia at initial diagnosis or relapse, aged less than 25 years
Receives: Other: Collection of blood sample of bone marrow (cohort 1)
Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemiaNot described
Receives: Other: Collection of blood sample of bone marrow (cohort 2 and 3)
Cohort 3 : Patients who undergo bone marrow aspiratePatients who undergo bone marrow aspirate as part of standard of care but without AML nor predisposition to develop AML, as controls
Receives: Other: Collection of blood sample of bone marrow (cohort 2 and 3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS)

    Measured: Up to 5 years

Secondary outcomes (23)

  1. Cumulative incidence of relapse (CIR) from remission status.

    Relapse is defined as:

    Bone marrow blasts ≥ 5% and/or evidence of extramedullary disease

    Measured: Up to 5 years

  2. Event Free Survival (EFS)

    Event Free Survival (EFS) is defined as the time from start of chemotherapy to failure, relapse, or death which ever occurs first

    Measured: Up to 5 years

  3. Disease Free Survival (DFS)

    Disease Free Survival (DFS) is defined as the time from remission status to relapse or death.

    Measured: Up to 5 years

  4. Number of mutations identified by WGS

    Number of mutations identified by Whole-Genome-Sequencing (WGS) as compared to Next-Generation Sequencing (NGS) in leukemic cells

    Measured: Up to 5 years

  5. Expression profile (transcriptome) of mesenchymal stem cells

    Expression profile (transcriptome) of mesenchymal stem cells at AML diagnosis and relapse compared to age matched controls without AML

    Measured: Up to 5 years

  6. Engraftment rate of primary leukemic cells

    Engraftment rate of primary leukemic cells in Patient-derived xenografts (PDX) or other experimental models

    Measured: Up to 5 years

  7. Matched rate of genetic mutational (or expression) profile between derived cells from experimental models to primary leukemic cells

    Measured: Up to 5 years

  8. Comparison of LSC signature profile of leukemic primary blasts at diagnosis and at relapse

    Measured: Up to 5 years

  9. Cumulative incidence of relapse according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse

    Cumulative incidence of relapse according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

    Measured: Up to 5 years

  10. EFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse

    Event Free Survival according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

    Measured: Up to 5 years

  11. DFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse

    Disease-Free Survival (DFS) according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

    Measured: Up to 5 years

  12. Ex vivo multidrug testing profile of leukemic primary blasts

    Comparison of ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

    Measured: Up ot 5 years

  13. Cumulative incidence of relapse according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

    Measured: Up to 5 years

  14. EFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

    Event-Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

    Measured: Up to 5 years

  15. DFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

    Disease Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

    Measured: Up to 5 years

  16. Mutational profile of patients

    Comparison of mutational profile of patients with a predisposition syndrome compared to mutational profile of patients with AML at diagnosis and relapse

    Measured: Up ot 5 years

  17. Percentage of MRD clearance

    MRD clearance is defined as MRD below 10-3 Evaluated by flow cytometry and high sensitivity NGS (defined as MRD below 10-4) after each chemotherapy course

    Measured: Up to 5 years

  18. Cumulative incidence of relapse according to MRD clearance

    Evaluated by flow cytometry at a sensitivity threshold of 10-3

    Measured: Up to 5 years

  19. EFS according to MRD clearance

    Evaluated by flow cytometry at a sensitivity threshold of 10-3

    Measured: Up to 5 years

  20. DFS according to MRD clearance

    Evaluated by flow cytometry at a sensitivity threshold of 10-3

    Measured: Up to 5 years

  21. Cumulative incidence of relapse according to MRD clearance

    Evaluated by high sensitivity NGS at a threshold of 10-4

    Measured: Up to 5 years

  22. EFS according to MRD clearance

    Evaluated by high sensitivity NGS at a threshold of 10-4

    Measured: Up to 5 years

  23. DFS according to MRD clearance

    Evaluated by high sensitivity NGS at a threshold of 10-4

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start31 May 2023
  3. Primary completion31 May 2033 (estimated)
  4. Study completion31 May 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772559
Sponsor's protocol ID
APHP220571
Acronym
ALARM3
Status last verified
Jun 2024
First submitted
6 Mar 2023
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia and Genetic Predisposition to Disease, run by Assistance Publique - Hôpitaux de Paris at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arnaud PETIT, Pr (+33 1 44 73 53 14, arnaud.petit@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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