Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02842333
Status:
COMPLETED
Last Update Posted:
2025-05-25
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UCP-specific Th1 responses measured by ELISPOT assay', 'timeFrame': 'at inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Leukemia']}, 'descriptionModule': {'briefSummary': 'The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.\n\nThe aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For cohort A :\n\n * patient with chronic myelogenous leukemia in chronic phase in deep molecular response (MR4.0) persistent for 2 years or more after end of TKi treatments\n * patient with total cessation of TKi treatment\n * signed written informed consent\n* For cohort B :\n\n * patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with TKIs (inclusion of patient under TKi treatment after relapse is possible).\n * signed written informed consent\n\nExclusion Criteria (for all patients) :\n\n* patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed)\n* active autoimmune diseases, HIV, hepatitis C or B virus\n* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.\n* patient under guardianship, curator or under the protection of justice.'}, 'identificationModule': {'nctId': 'NCT02842333', 'acronym': 'PAMIR01', 'briefTitle': 'Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor', 'orgStudyIdInfo': {'id': 'P/2015/263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional biological samples', 'description': 'Blood samples will be realized at inclusion and 6 months after inclusion (optional).\n\nPeripheral Blood Mononuclear Cells (PBMC) will be collected.', 'interventionNames': ['Other: Additional biological samples']}], 'interventions': [{'name': 'Additional biological samples', 'type': 'OTHER', 'description': 'Blood samples', 'armGroupLabels': ['Additional biological samples']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}