Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-18 @ 5:45 PM
Study NCT ID:
NCT01650467
Status:
WITHDRAWN
Last Update Posted:
2017-02-01
First Post:
2012-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], 'ancestors': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two 7 ml EDTA tubes for genotyping abl and bcr-abl polymorphisms'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding is late, unforseeable.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2012-07-24', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abl genotype', 'timeFrame': 'baseline ; at diagnosis', 'description': 'The abl genotype will be determined for all subjects'}], 'secondaryOutcomes': [{'measure': 'abl genotype', 'timeFrame': '12 months after diagnosis', 'description': 'The abl genotype will be determined for all subjects'}, {'measure': 'bcr-abl leucemic fraction genotype', 'timeFrame': '12 months after diagnosis', 'description': 'The bcr-able leucemic fraction genotype will be determined for CML patients'}, {'measure': 'bcr-abl leucemic fraction genotype', 'timeFrame': 'baseline ; at diagnosis', 'description': 'The bcr-able leucemic fraction genotype will be determined for CML patients'}, {'measure': 'abl non-leucemic fraction genotype', 'timeFrame': 'baseline ; at diagnosis', 'description': 'The abl non-leucemic fraction genotype will be determined for CML patients'}, {'measure': 'abl non-leucemic fraction genotype', 'timeFrame': '12 months after diagnosis', 'description': 'The abl non-leucemic fraction genotype will be determined for CML patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abl polymorphisms'], 'conditions': ['Leukemia, Myeloid, Chronic-Phase']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.', 'detailedDescription': 'The first secondary objective of this study is to identify, in patients not responding to treatment, possible changes in the polymorphisms of interest during the course of the disease, reclassifying such polymorphisms as mutations.\n\nThe second secondary objective is to compare the control patients in terms of polymorphism frequency on the nonpathological abl fraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will include 60 healthy controls (free of hematologic pathology, seen in genetic counseling) and stratify the recruitment of patients with CML among 30 patients with optimal imatinib response and 30 with primary resistance.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n\nInclusion Criteria for all CML patients\n\n* Patients diagnosed with CML\n* Treatment with Imatinib in first-line monotherapy and this for at least 12 months\n* RNA and / or cDNA used for diagnosis correctly stored in the biobank\n\nInclusion Criteria for CML patients already having undergone a follow-up visit at 12 months\n\n* RNA and / or cDNA used for diagnosis/follow-up correctly stored in the biobank\n* Cytogenetic results are available\n* Absence of ITK mutation for the primary resistance subgroup\n* Validated compliance\n\nInclusion Criteria for the optimal response group:\n\n* bcr-abl typing is less than 0.1% at 12 months\n\nInclusion criteria for the primary resistance group\n\n* bcr-abl typings is \\>1% and/or Philadelphia+ is greater than 0\n\nInclusion Criteria for the control population\n\n* Absence of hematologic malignancy\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* The patient has a contraindication for a treatment used in this study\n\nExclusion Criteria for CML patients already having undergone a follow-up visit at 12 months\n\n* Known or suspected cause for resistance (dose reduced due to intolerance, digestive disease responsible for malabsorption ...)\n\nExclusion Criteria for the control population\n\n* History or suspicion of hemopathy'}, 'identificationModule': {'nctId': 'NCT01650467', 'acronym': 'abl LMC', 'briefTitle': 'Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms', 'orgStudyIdInfo': {'id': 'LOCAL/2012/JBG-02'}, 'secondaryIdInfos': [{'id': '2012-A00639-34', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy controls', 'description': '60 healthy controls with no hematological pathologies'}, {'label': 'Imatinib optimal response', 'description': '30 CML patients who are optimal responders to imatinib treatment'}, {'label': 'Imatinib primary resistance', 'description': '30 CML patients who have primary resistance to imatinib treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34170', 'city': 'Castelnau-le-Lez', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 43.63605, 'lon': 3.90137}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Saint-Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Jean-Baptiste Gaillard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}