Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT00724360
Status:
TERMINATED
Last Update Posted:
2013-10-07
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Difficulties of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)'}], 'secondaryOutcomes': [{'measure': 'Trastuzumab efficiency concerning transfusional needs'}, {'measure': 'Overall survival'}, {'measure': 'Leukemia free survival'}, {'measure': 'cytogenetic response rate'}, {'measure': 'Trastuzumab tolerance profile'}]}, 'conditionsModule': {'keywords': ['relapsed/refractory', 'HER2', 'positive', 'B-ALL', 'trastuzumab'], 'conditions': ['Relapsed/Refractory Leukemia']}, 'referencesModule': {'references': [{'pmid': '22267607', 'type': 'DERIVED', 'citation': 'Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* B-ALL in relapse\n* refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale\n* adequate hepatic and renal functions (AST or ALT \\<= 5 times the upper limit of normal creatinine \\< 2 times the upper limit of normal)\n* \\> 20% blasts in bone marrow,\n* \\> 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping\n\nExclusion Criteria:\n\n* Previous treatment by trastuzumab\n* FEVG \\< 50%'}, 'identificationModule': {'nctId': 'NCT00724360', 'briefTitle': 'Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.', 'orgStudyIdInfo': {'id': 'BRD04/2-T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Herceptin (trastuzumab)', 'type': 'DRUG', 'description': 'Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'St Louis Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}