Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-08 @ 7:08 AM
Study NCT ID:
NCT04931992
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients \\< 61 years with CBF and/or NPM1-mutated AML in CR1 after induction therapy who did not receive allogeneic stem transplantation and who were followed for measurable residual disease after completion of treatment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 61 years\n* Diagnosis between 2010 and 2019\n* Core binding factor and/or NPM1 acute myeloid leukemia\n* First complete remission after induction therapy\n* Measurable residual disease measurement after end of consolidation therapy\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia\n* Allogeneic stem cell transplantation in CR1'}, 'identificationModule': {'nctId': 'NCT04931992', 'acronym': 'MOLAM', 'briefTitle': 'Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.', 'orgStudyIdInfo': {'id': '202100042'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Molecular relapse', 'description': 'Confirmed molecular relapse, without overt cytological relapse', 'interventionNames': ['Other: No intervention']}, {'label': 'Cytological relapse', 'description': 'Overt cytological relapse, without prior molecular relapse', 'interventionNames': ['Other: No intervention']}, {'label': 'Persistent responders', 'description': 'No molecular or cytological relapse during follow-up', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Retrospective analysis', 'armGroupLabels': ['Cytological relapse', 'Molecular relapse', 'Persistent responders']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corentin Orvain, MD, PhD', 'role': 'CONTACT', 'email': 'corentin.orvain@chu-angers.fr', 'phone': '+33241354475'}], 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Corentin Orvain, MD, PhD', 'role': 'CONTACT', 'email': 'corentin.orvain@chu-angers.fr', 'phone': '+33241354475'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}