Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-06 @ 7:00 PM
Study NCT ID:
NCT02938858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Registry of First-line Treatment of Acute Promyelocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015473', 'term': 'Leukemia, Promyelocytic, Acute'}], 'ancestors': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'From date of induction until the date of first documented event, assessed up to 60 months', 'description': 'events are: no achievement of haematological complete remission after induction therapy; no achievement of molecular remission after the consolidation courses; relapse; death including early death'}], 'secondaryOutcomes': [{'measure': 'Rate of hematological complete remission', 'timeFrame': 'up to 30 days', 'description': 'from date of inclusion until end of induction therapy'}, {'measure': 'Rate of overall survival', 'timeFrame': 'at 5 years', 'description': 'Overall survival defined as the time from inclusion until death or end of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Promyelocytic Leukemia']}, 'descriptionModule': {'briefSummary': "The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.", 'detailedDescription': '* Collection of epidemiological data on non-high-risk APL patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, Performance status…).\n* Documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk APL patients.\n* Documentation of Minimal Residual Disease (MRD).\n* Correlation of clinical outcomes with the chosen therapy.\n* Validation of published prognostic factors and identification of new prognostic factors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count \\< 10000/μl) aged ≤ 70 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly-diagnosed APL (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript PML/RARα.\n* Non-high-risk APL (White Blood Count \\< 10000/μl at presentation)\n* Age ≤ 70 years\n\nExclusion Criteria:\n\n* Relapsed APL\n* Newly-diagnosed High-risk APL (White Blood Count \\> 10000/μl at presentation)\n* Age \\> 70 years'}, 'identificationModule': {'nctId': 'NCT02938858', 'briefTitle': 'French Registry of First-line Treatment of Acute Promyelocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Francophone des Myelodysplasies'}, 'officialTitle': 'The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years', 'orgStudyIdInfo': {'id': 'French registry APL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ATRA-chimio', 'description': 'according to usual practice center'}, {'label': 'ATRA-ATO', 'description': 'according to usual practice center'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13616', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': "Centre Hospitalier d'Aix en Provence", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Groupe Hospitalier SUD', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '95107', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier V. Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux Pellegrin enfant', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest - Pédiatrie Spécialisée', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '63100', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94100', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Hopital Andre Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '62307', 'city': 'Lens', 'country': 'France', 'facility': 'CH Dr Schaffner', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Chru - Hopital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hôpital universitaire Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Chu Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville - Hôpital de Marcy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34095', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44035', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'facility': 'Hôpital de la Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital TROUSSEAU', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35203', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Hôpital Sud - service Hémato-oncologie Pédiatrique', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '59056', 'city': 'Roubaix', 'country': 'France', 'facility': 'Hôpital V. Provo', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancerologie de La Loire', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'IUCT Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Pierre FENAUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French APL Cooperative Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Francophone des Myelodysplasies', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}