Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-28 @ 2:30 PM
Study NCT ID:
NCT01057459
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Analysis in Predicting Response to Antibody Therapy in Patients With Follicular Lymphoma Treated on Clinical Trials CALGB-50402 or CALGB-50701
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2014-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Baseline'}, {'measure': 'Overall survival', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stage II Grade 1 Contiguous Follicular Lymphoma', 'Stage II Grade 1 Non-Contiguous Follicular Lymphoma', 'Stage II Grade 2 Contiguous Follicular Lymphoma', 'Stage II Grade 2 Non-Contiguous Follicular Lymphoma', 'Stage II Grade 3 Contiguous Follicular Lymphoma', 'Stage II Grade 3 Non-Contiguous Follicular Lymphoma', 'stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'This research trial studies deoxyribonucleic acid (DNA) analysis in predicting response to antibody therapy in patients with follicular lymphoma treated on clinical trials Cancer and Leukemia Group B (CALGB)-50402 or CALGB-50701. Studying samples of blood from patients with follicular lymphoma in the laboratory may help doctors predict how well patients will respond to treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nl. To test the hypothesis that killer immunoglobulin-like receptor (KIR) and human leukocyte antigen (HLA) genotypes predict overall response (partial response \\[PR\\], complete response\\[CR\\], and unconfirmed complete response \\[CRu\\]) within 12 months to rituximab-containing monoclonal antibody combinations in follicular lymphoma patients treated on CALGB protocols 50402 and 50701.\n\nSECONDARY OBJECTIVES:\n\nI. To test the hypothesis that KIR and HLA genotypes are associated with survival outcomes (progression-free survival \\[PFS\\] and overall survival \\[OS\\]) in follicular lymphoma patients treated with rituximab-containing monoclonal antibody combinations on CALGB protocols 50402 and 50701.\n\nOUTLINE:\n\nGenomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with follicular lymphoma treated on CALGB 50402 or 50701 protocols', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Untreated follicular lymphoma\n* Has received rituximab-containing monoclonal antibody therapy on CALGB-50402 or CALGB-50701\n* Patients have previously provided informed consent allowing correlative studies on genomic DNA'}, 'identificationModule': {'nctId': 'NCT01057459', 'briefTitle': 'DNA Analysis in Predicting Response to Antibody Therapy in Patients With Follicular Lymphoma Treated on Clinical Trials CALGB-50402 or CALGB-50701', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Natural Killer Cell KIR and HLA Genotypes May Predict Response to Antibody Therapy in Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'CALGB-150905'}, 'secondaryIdInfos': [{'id': 'CDR0000664103'}, {'id': 'NCI-2011-02204', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}, {'id': 'U10CA180821', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180821', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (biomarkers and treatment outcomes)', 'description': 'Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.', 'interventionNames': ['Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (biomarkers and treatment outcomes)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Venstrom, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}