Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-05 @ 11:30 PM
Study NCT ID:
NCT03663894
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival after relapse (SAR) post ASCT in follicular lymphoma', 'timeFrame': 'Year 6', 'description': 'Factors that predicted SAR'}], 'secondaryOutcomes': [{'measure': 'Histological Transformation at relapse', 'timeFrame': 'Year 6', 'description': 'A biopsy was performed at the first relapse or progression after ASCT.'}, {'measure': 'treatment of relapse', 'timeFrame': 'Year 6', 'description': 'Chemotherapy, radiotherapy…'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous stem cell transplantation', 'rituximab', 'Follicular Lymphoma', 'prognosis'], 'conditions': ["Patient's Outcome Prognostic Factors"]}, 'descriptionModule': {'briefSummary': "Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.\n\nPatients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '95 consecutive patients who fulfilled the eligibility criteria for this study were reviewed retrospectively with data cut-off of December 2014. FL patients in relapse after ASCT. All patients presented at diagnosis a grade 1, 2, or 3A follicular lymphoma confirmed by either excisional or core needle biopsy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* they were older than 18 years\n* presented FL at diagnosis (Grade 1, 2, or 3a).\n* received high-dose therapy (HDT) with ASCT from 2000 to 2014\n\nExclusion Criteria:\n\n1. they had already been treated with a 1st ASCT,\n2. had a previous history of histological transformation before ASCT\n3. if they were rituximab naive prior to ASCT.'}, 'identificationModule': {'nctId': 'NCT03663894', 'briefTitle': 'Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era', 'orgStudyIdInfo': {'id': 'ASCT Sesques'}}, 'contactsLocationsModule': {'locations': [{'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud, Hematology department', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Pierre SESQUES, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}