Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies
NCT ID: NCT05772559
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-05-31
2033-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 : Patients with acute myeloid leukemia
Patients with acute myeloid leukemia at initial diagnosis or relapse, aged less than 25 years
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
Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemia
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)
Cohort 3 : Patients who undergo bone marrow aspirate
Patients who undergo bone marrow aspirate as part of standard of care but without AML nor predisposition to develop AML, as controls
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)
Interventions
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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
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Chronic myeloid leukemia (CML)
* Lack of health insurance (French social security)
* Under protection (tutelle, curatelle or sauvegarde de justice)
* Pregnancy or breastfeeding
25 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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CHU Amiens Picardie site Sud
Amiens, , France
CHU Angers
Angers, , France
Hopital Minjoz
Besançon, , France
CHU Pellegrin
Bordeaux, , France
CHRU Morvan
Brest, , France
CHU Caen
Caen, , France
CHU Estaing
Clermont-Ferrand, , France
CHU Francois Mitterand
Dijon, , France
CHU Grenoble
Grenoble, , France
CHU de la Réunion
La Réunion, , France
Hopital Jeanne de Flandre - CHRU
Lille, , France
CHU Limoges
Limoges, , France
HCL Lyon
Lyon, , France
Hôpital d'Enfants de la Timone
Marseille, , France
CHU Montpellier
Montpellier, , France
CHRU Nancy- Hopitaux de Brabois
Nancy, , France
CHU Nantes
Nantes, , France
CHU Nice
Nice, , France
Hopital Robert Debré
Paris, , France
Hopital Trousseau
Paris, , France
CHU Poitiers
Poitiers, , France
Hopital Américain
Reims, , France
CHU Hopital Sud
Rennes, , France
CHU Rouen
Rouen, , France
CHU Saint Etienne
Saint-Etienne, , France
Hopital Hautepierre
Strasbourg, , France
CHU Toulouse
Toulouse, , France
CHRU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Camille Leglise, MD
Role: primary
Isabelle Pellier, MD
Role: primary
Nathalie Cheikh, MD
Role: primary
Stéphane Ducassou, MD
Role: primary
Liana Carausu, MD
Role: primary
Jérémie Rouger, MD
Role: primary
Justyna Kanold, MD
Role: primary
Claire Desplante, MD
Role: primary
Corinne Armari Alla, MD
Role: primary
Yves Reguerre, MD
Role: primary
Brigitte Nelken, MD
Role: primary
Thomas Louvray, MD
Role: primary
Cécile Renard, MD
Role: primary
Paul Saultier, MD
Role: primary
Stéphanie Haouy, MD
Role: primary
Marion Lubnau, MD
Role: primary
Fanny Rialland, MD
Role: primary
Marilyne Poirée, MD
Role: primary
Marion Strullu, MD
Role: primary
Arnaud Petit, MD PhD
Role: primary
Frédéric Millot, MD
Role: primary
Claire Pluchart, MD
Role: primary
Virginie Gandemer, MD
Role: primary
Nimrod Buchbinde, MD
Role: primary
Sandrine Thouvenin-Doulet, MD
Role: primary
Catherine Paillard, MD
Role: primary
Marlène Pasquet, MD
Role: primary
Julien Lejeune, MD
Role: primary
Other Identifiers
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APHP220571
Identifier Type: -
Identifier Source: org_study_id
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