Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-28 @ 7:50 PM
Study NCT ID:
NCT05772559
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2033-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of somatic mutations in leukemic cells between diagnosis and relapse identified by Next-Generation Sequencing (NGS)', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of relapse (CIR) from remission status.', 'timeFrame': 'Up to 5 years', 'description': 'Relapse is defined as:\n\nBone marrow blasts ≥ 5% and/or evidence of extramedullary disease'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'Up to 5 years', 'description': 'Event Free Survival (EFS) is defined as the time from start of chemotherapy to failure, relapse, or death which ever occurs first'}, {'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'Up to 5 years', 'description': 'Disease Free Survival (DFS) is defined as the time from remission status to relapse or death.'}, {'measure': 'Number of mutations identified by WGS', 'timeFrame': 'Up to 5 years', 'description': 'Number of mutations identified by Whole-Genome-Sequencing (WGS) as compared to Next-Generation Sequencing (NGS) in leukemic cells'}, {'measure': 'Expression profile (transcriptome) of mesenchymal stem cells', 'timeFrame': 'Up to 5 years', 'description': 'Expression profile (transcriptome) of mesenchymal stem cells at AML diagnosis and relapse compared to age matched controls without AML'}, {'measure': 'Engraftment rate of primary leukemic cells', 'timeFrame': 'Up to 5 years', 'description': 'Engraftment rate of primary leukemic cells in Patient-derived xenografts (PDX) or other experimental models'}, {'measure': 'Matched rate of genetic mutational (or expression) profile between derived cells from experimental models to primary leukemic cells', 'timeFrame': 'Up to 5 years'}, {'measure': 'Comparison of LSC signature profile of leukemic primary blasts at diagnosis and at relapse', 'timeFrame': 'Up to 5 years'}, {'measure': 'Cumulative incidence of relapse according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse', 'timeFrame': 'Up to 5 years', 'description': 'Cumulative incidence of relapse according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse'}, {'measure': 'EFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse', 'timeFrame': 'Up to 5 years', 'description': 'Event Free Survival according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse'}, {'measure': 'DFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse', 'timeFrame': 'Up to 5 years', 'description': 'Disease-Free Survival (DFS) according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse'}, {'measure': 'Ex vivo multidrug testing profile of leukemic primary blasts', 'timeFrame': 'Up ot 5 years', 'description': 'Comparison of ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse'}, {'measure': 'Cumulative incidence of relapse according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse', 'timeFrame': 'Up to 5 years'}, {'measure': 'EFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse', 'timeFrame': 'Up to 5 years', 'description': 'Event-Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse'}, {'measure': 'DFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse', 'timeFrame': 'Up to 5 years', 'description': 'Disease Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse'}, {'measure': 'Mutational profile of patients', 'timeFrame': 'Up ot 5 years', 'description': 'Comparison of mutational profile of patients with a predisposition syndrome compared to mutational profile of patients with AML at diagnosis and relapse'}, {'measure': 'Percentage of MRD clearance', 'timeFrame': 'Up to 5 years', 'description': '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'}, {'measure': 'Cumulative incidence of relapse according to MRD clearance', 'timeFrame': 'Up to 5 years', 'description': 'Evaluated by flow cytometry at a sensitivity threshold of 10-3'}, {'measure': 'EFS according to MRD clearance', 'timeFrame': 'Up to 5 years', 'description': 'Evaluated by flow cytometry at a sensitivity threshold of 10-3'}, {'measure': 'DFS according to MRD clearance', 'timeFrame': 'Up to 5 years', 'description': 'Evaluated by flow cytometry at a sensitivity threshold of 10-3'}, {'measure': 'Cumulative incidence of relapse according to MRD clearance', 'timeFrame': 'Up to 5 years', 'description': 'Evaluated by high sensitivity NGS at a threshold of 10-4'}, {'measure': 'EFS according to MRD clearance', 'timeFrame': 'Up to 5 years', 'description': 'Evaluated by high sensitivity NGS at a threshold of 10-4'}, {'measure': 'DFS according to MRD clearance', 'timeFrame': 'Up to 5 years', 'description': 'Evaluated by high sensitivity NGS at a threshold of 10-4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Genetic Predisposition to Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0-25 years old\n* Newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML) or\n* Relapsed or refractory AML or\n* Patients with genetic predisposition to develop AML or\n* Patients without haematological malignancy nor AML genetic predisposition syndrome who undergo bone marrow aspirate as part of standard of care\n* 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.\n\nExclusion Criteria:\n\n* Refuse to participate\n* Chronic myeloid leukemia (CML)\n* Lack of health insurance (French social security)\n* Under protection (tutelle, curatelle or sauvegarde de justice)\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05772559', 'acronym': 'ALARM3', 'briefTitle': 'Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies - ALARM3', 'orgStudyIdInfo': {'id': 'APHP220571'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 : Patients with acute myeloid leukemia', 'description': 'Patients with acute myeloid leukemia at initial diagnosis or relapse, aged less than 25 years', 'interventionNames': ['Other: Collection of blood sample of bone marrow (cohort 1)']}, {'label': 'Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemia', 'interventionNames': ['Other: Collection of blood sample of bone marrow (cohort 2 and 3)']}, {'label': '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', 'interventionNames': ['Other: Collection of blood sample of bone marrow (cohort 2 and 3)']}], 'interventions': [{'name': 'Collection of blood sample of bone marrow (cohort 1)', 'type': 'OTHER', 'description': '* 3 additional tubes of blood sample (cohort 1), at diagnosis and upon relapse if relapse occurs\n* Bone marrow aspirate : 3 additional tubes (cohort 1), at diagnosis and upon relapse if relapse occurs', 'armGroupLabels': ['Cohort 1 : Patients with acute myeloid leukemia']}, {'name': 'Collection of blood sample of bone marrow (cohort 2 and 3)', 'type': 'OTHER', 'description': '* 1 additional tube of blood sample (cohort 2 and 3 at inclusion)\n* Bone marrow aspirate: 1 additional tube (cohort 2 and 3 at inclusion)', 'armGroupLabels': ['Cohort 2 : Patients with genetic predisposition to develop acute myeloid leukemia', 'Cohort 3 : Patients who undergo bone marrow aspirate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Camille Leglise, MD', 'role': 'CONTACT'}], 'facility': 'CHU Amiens Picardie site Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle Pellier, MD', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie Cheikh, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Ducassou, MD', 'role': 'CONTACT'}], 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Liana Carausu, MD', 'role': 'CONTACT'}], 'facility': 'CHRU Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémie Rouger, MD', 'role': 'CONTACT'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Justyna Kanold, MD', 'role': 'CONTACT'}], 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire Desplante, MD', 'role': 'CONTACT'}], 'facility': 'CHU Francois Mitterand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corinne Armari Alla, MD', 'role': 'CONTACT'}], 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'La Réunion', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves Reguerre, MD', 'role': 'CONTACT'}], 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': 44.29707, 'lon': 0.11776}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte Nelken, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Jeanne de Flandre - CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas Louvray, MD', 'role': 'CONTACT'}], 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile Renard, MD', 'role': 'CONTACT'}], 'facility': 'HCL Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Paul Saultier, MD', 'role': 'CONTACT'}], 'facility': "Hôpital d'Enfants de la Timone", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie Haouy, MD', 'role': 'CONTACT'}], 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion Lubnau, MD', 'role': 'CONTACT'}], 'facility': 'CHRU Nancy- Hopitaux de Brabois', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fanny Rialland, MD', 'role': 'CONTACT'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marilyne Poirée, MD', 'role': 'CONTACT'}], 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion Strullu, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud Petit, MD PhD', 'role': 'CONTACT'}], 'facility': 'Hopital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric Millot, MD', 'role': 'CONTACT'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire Pluchart, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Américain', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Virginie Gandemer, MD', 'role': 'CONTACT'}], 'facility': 'CHU Hopital Sud', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nimrod Buchbinde, MD', 'role': 'CONTACT'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sandrine Thouvenin-Doulet, MD', 'role': 'CONTACT'}], 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine Paillard, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marlène Pasquet, MD', 'role': 'CONTACT'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Lejeune, MD', 'role': 'CONTACT'}], 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Arnaud PETIT, Pr', 'role': 'CONTACT', 'email': 'arnaud.petit@aphp.fr', 'phone': '+33 1 44 73 53 14'}, {'name': 'Jérôme Lambert, Pr', 'role': 'CONTACT', 'email': 'jerome.lambert@u-paris.fr', 'phone': '142499742', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}