Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-23 @ 12:12 PM
Study NCT ID:
NCT00113802
Status:
TERMINATED
Last Update Posted:
2021-08-19
First Post:
2005-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C448700', 'term': 'epratuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 31}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2005-06-10', 'studyFirstSubmitQcDate': '2005-06-10', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum measurements of IgM will be the primary determination of efficacy.'}]}, 'conditionsModule': {'keywords': ['Epratuzumab (hLL2- anti-CD22 humanized antibody)', "Waldenstrom's Macroglobulinemia", 'Waldenstrom Macroglobulinemia', 'Hematologic Disease', 'Hematologic Diseases', 'Paraproteinemias', 'Vascular Hemostatic Disorders', 'Lymphoproliferative Disorders'], 'conditions': ['Waldenstrom Macroglobulinemia']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether epratuzumab provides effective therapy in Waldenström's Macroglobulinemia (WM).", 'detailedDescription': "This multi-center, single-arm study of epratuzumab is in patients with Waldenström's Macroglobulinemia (WM) who failed chemotherapy. After baseline evaluations, patients receive epratuzumab infused over approximately 30-60 minutes at 360 mg/m2, administered once weekly for 4 consecutive weeks (days 1, 8, 15, 22). Post-treatment evaluations occur on the day of the last infusion, then at 6 and 12 weeks. Patients without progression of disease continue long-term follow up until disease progression or for at least 5 years, with evaluations every 3 months for 2 years, then semi-annually. Otherwise, follow-up is only required until resolution of any treatment related abnormalities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of Waldenström's Macroglobulinemia using criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.\n* Measurable disease, defined as serum monoclonal IgM protein ≥1000 mg/dL by electrophoresis.\n* Lymphoplasmacytic infiltration of the bone marrow \\>10% involvement.\n* Failed at least one, but no more than 3, regimen(s) of prior therapy.\n\n(Please consult with study site for full eligibility criteria)"}, 'identificationModule': {'nctId': 'NCT00113802', 'briefTitle': "Study of Epratuzumab (hLL2) in Patients With Waldenstrom's Macroglobulinemia", 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': "A Phase II, Single-Arm Trial of Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients With Waldenstrom's Macroglobulinemia", 'orgStudyIdInfo': {'id': 'IM-T-hLL2-18-US'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epratuzumab (hLL2- anti-CD22 humanized antibody)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell/ New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University College of Physicans & Surgeons', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}}}}