Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-04 @ 9:54 PM
Study NCT ID:
NCT00285428
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2006-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C493846', 'term': 'veltuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2006-01-31', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerance of different dose levels', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Lack of immunogenicity', 'timeFrame': '8 and 12 weeks'}, {'measure': 'Pharmacodynamics', 'timeFrame': 'over 12 weeks'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'over 12 weeks'}, {'measure': 'Efficacy', 'timeFrame': '4, 8 and 12 wks, every 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment', 'NHL', 'CD20+ B-cell NHL', 'Lymphoma'], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'referencesModule': {'references': [{'pmid': '20214444', 'type': 'BACKGROUND', 'citation': 'Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.'}, {'pmid': '19451441', 'type': 'RESULT', 'citation': "Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18."}]}, 'descriptionModule': {'briefSummary': "This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease"}, 'identificationModule': {'nctId': 'NCT00285428', 'briefTitle': "Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma", 'nctIdAliases': ['NCT00112970'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': "A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'IM-T-hA20-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose level 1', 'description': '120 mg/m2', 'interventionNames': ['Drug: hA20-humanized anti-CD20 antibody']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level 2', 'description': '200 mg/m2', 'interventionNames': ['Drug: hA20-humanized anti-CD20 antibody']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'description': '375 mg/m2', 'interventionNames': ['Drug: hA20-humanized anti-CD20 antibody']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level 1B', 'description': '80 mg/m2', 'interventionNames': ['Drug: hA20-humanized anti-CD20 antibody']}], 'interventions': [{'name': 'hA20-humanized anti-CD20 antibody', 'type': 'DRUG', 'otherNames': ['veltuzumab', 'IMMU-106', 'hA20'], 'description': 'once weekly iv dosing for 4 weeks', 'armGroupLabels': ['Dose Level 3', 'Dose level 1', 'Dose level 1B', 'Dose level 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital/Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Hospital of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'William Wegener, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'William Wegener, MD, PhD', 'oldOrganization': 'Immunomedics, Inc.'}}}}