Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00162656
Status:
COMPLETED
Last Update Posted:
2012-03-28
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Mature B-cell Lymphoma/Leukaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 848}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-27', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival', 'timeFrame': '3 years', 'description': 'Event free survival (event = progressive disease or relapse or second malignancy or death from any cause)'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '3 years'}, {'measure': 'long term toxicity', 'timeFrame': '10 years', 'description': 'long term toxicity: cardiotoxicity, impaired fertility, secondary malignancy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['B-Cell Lymphoma'], 'conditions': ['B-Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '30117142', 'type': 'DERIVED', 'citation': 'Frazer JK, Li KJ, Galardy PJ, Perkins SL, Auperin A, Anderson JR, Pinkerton R, Buxton A, Gross TG, Michon J, Leverger G, Weinstein HJ, Harrison L, Shiramizu B, Barth MJ, Goldman SC, Patte C, Cairo MS. Excellent outcomes in children and adolescents with CNS+ Burkitt lymphoma or other mature B-NHL using only intrathecal and systemic chemoimmunotherapy: results from FAB/LMB96 and COG ANHL01P1. Br J Haematol. 2019 Apr;185(2):374-377. doi: 10.1111/bjh.15520. Epub 2018 Aug 16. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment', 'detailedDescription': 'Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89 therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both reduction and deletion. Randomization occurs following COPADM1 and is stratified for national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy III+LDH\\<2N; Murphy III+LDH\\>2N or Murphy IV).\n\nThe primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS\n\nGroup C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2 and is stratified for national group, histology (large cell; small non cleaved cell) and CNS disease.\n\nThe primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow \\> 5% L3 blasts.\n* Pre treatment imaging studies adequate to document Murphy disease stage\n* Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts)\n* Patients should be available for a minimum follow up of 36 months\n* Informed consent prior to study entry\n\nExclusion Criteria:\n\n* Anaplastic large cell Ki 1 positive lymphomas\n* Previous chemotherapy.\n* Congenital immunodeficiency\n* Prior organ transplantation\n* Previous malignancy of any type\n* Known HIV positivity"}, 'identificationModule': {'nctId': 'NCT00162656', 'briefTitle': 'Treatment of Mature B-cell Lymphoma/Leukaemia', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Treatment of Mature B-cell Lymphoma/Leukaemia A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study', 'orgStudyIdInfo': {'id': 'FAB LMB96'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard LMB B', 'interventionNames': ['Drug: LMB B']}, {'type': 'EXPERIMENTAL', 'label': 'LMB B without COPADM3', 'interventionNames': ['Drug: without COPADM3']}, {'type': 'EXPERIMENTAL', 'label': 'LMB B with half cyclophosphamide', 'interventionNames': ['Drug: half cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'LMB B without COPADM3 and with half cyclophosphamide', 'interventionNames': ['Drug: half cyclophosphamide', 'Drug: without COPADM3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LMB C standard', 'interventionNames': ['Drug: LMB C']}, {'type': 'EXPERIMENTAL', 'label': 'LMB C with mini CYVE and without 3 maintenance courses', 'interventionNames': ['Drug: mini CYVE, without 3 maintenance courses']}], 'interventions': [{'name': 'half cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['LMB B with half cyclophosphamide', 'LMB B without COPADM3 and with half cyclophosphamide']}, {'name': 'without COPADM3', 'type': 'DRUG', 'armGroupLabels': ['LMB B without COPADM3', 'LMB B without COPADM3 and with half cyclophosphamide']}, {'name': 'mini CYVE, without 3 maintenance courses', 'type': 'DRUG', 'armGroupLabels': ['LMB C with mini CYVE and without 3 maintenance courses']}, {'name': 'LMB B', 'type': 'DRUG', 'armGroupLabels': ['Standard LMB B']}, {'name': 'LMB C', 'type': 'DRUG', 'armGroupLabels': ['LMB C standard']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Morgan Stanley Childrens Hospital of New York Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': "Sheffield Children's Hospital", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Catherine Patte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}, {'name': 'Mitchell S Cairo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Morgan Stanley Childrens Hospital of New York Presbyterian, Columbia University'}, {'name': 'Mary Gerrard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sheffield Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}