Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 1:21 AM
Study NCT ID:
NCT00373906
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2006-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Velcade in MALT Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2006-09-07', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the clinical potential of bortezomib'}, {'measure': 'to induce objective/histologic responses in patients with MALT-Lymphoma'}], 'secondaryOutcomes': [{'measure': 'to evaluate the impact of bortezomib on progression free survival'}]}, 'conditionsModule': {'keywords': ['MALT Lymphoma, Bortezomib'], 'conditions': ['MALT Lymphoma']}, 'referencesModule': {'references': [{'pmid': '19336742', 'type': 'DERIVED', 'citation': 'Troch M, Jonak C, Mullauer L, Puspok A, Formanek M, Hauff W, Zielinski CC, Chott A, Raderer M. A phase II study of bortezomib in patients with MALT lymphoma. Haematologica. 2009 May;94(5):738-42. doi: 10.3324/haematol.2008.001537. Epub 2009 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.', 'detailedDescription': 'The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation.\n\nIt is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV)\n* with first or greater relapse after HP-eradication, radiation or chemotherapy ,\n* age \\> 18 years\n* must be able to tolerate therapy and have adequate cardiac, renal and hepatic function\n* ECOG status of \\<\\_ 2\n* must be capable of understanding the purpose of the study and given written informed consent'}, 'identificationModule': {'nctId': 'NCT00373906', 'briefTitle': 'Velcade in MALT Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type', 'orgStudyIdInfo': {'id': 'Velcade-MALT-Lymphoma'}, 'secondaryIdInfos': [{'id': 'Eudract No 2005-003077-25'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Bortezomib (Velcade)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Markus Raderer, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine I'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}}}}