Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT00225212
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2005-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nbirkett@stanford.edu', 'phone': '650-723-6456', 'title': 'Neal Birkett, MS, RAC', 'organization': 'Stanford University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rituximab After ASCT', 'description': 'Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT', 'otherNumAtRisk': 35, 'otherNumAffected': 9, 'seriousNumAtRisk': 35, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Blood and lymphatic system disorders - Other, neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Blood and lymphatic system disorders - Other, Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE v4'}], 'seriousEvents': [{'term': 'Blood and lymphatic system disorders - Other, neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 45, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Pneumonitis, BCNU-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Death NOS, pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, Community acquired pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCAE v4'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCAE v4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab After ASCT', 'description': 'Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': '"Events" for EFS were defined as the earlier of post-ASCT relapse or death.', 'unitOfMeasure': 'percentage of not experiencing EFS event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab After ASCT', 'description': 'Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'unitOfMeasure': 'percentage of subjects remaining alive', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab After ASCT', 'description': 'Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab After ASCT', 'description': 'Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'aged 16 and older', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'description': 'B-cell lymphoma patients aged 16 and older', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lymphoma sub-types', 'classes': [{'title': 'Diffuse large B-cell lymphoma (DLCL)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Mantle cell lymphoma (MCL)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Transformed lymphoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other B-cell lymphoma', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-04', 'studyFirstSubmitDate': '2005-09-21', 'resultsFirstSubmitDate': '2014-08-26', 'studyFirstSubmitQcDate': '2005-09-21', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-26', 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': '24 months', 'description': '"Events" for EFS were defined as the earlier of post-ASCT relapse or death.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["non-Hodgkin's lymphoma", 'diffuse large cell lymphoma', 'mantle cell lymphoma', 'transformed lymphoma', 'other subtypes of B cell lymphoma', 'recurrent lymphoma'], 'conditions': ["Non-Hodgkin's Lymphoma", 'Diffuse Large Cell Lymphoma', 'Mantle Cell Lymphoma', 'Transformed Lymphoma', 'Other Subtypes of B-cell Lymphoma', 'Lymphoma']}, 'referencesModule': {'references': [{'pmid': '12907446', 'type': 'RESULT', 'citation': 'Horwitz SM, Negrin RS, Blume KG, Breslin S, Stuart MJ, Stockerl-Goldstein KE, Johnston LJ, Wong RM, Shizuru JA, Horning SJ. Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin lymphoma. Blood. 2004 Feb 1;103(3):777-83. doi: 10.1182/blood-2003-04-1257. Epub 2003 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.\n\nThis study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.\n\nPreliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.', 'detailedDescription': 'The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.\n\nAfter an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* B-cell, CD20+ NHL\n* Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Creatinine \\< 2 mg/dL\n* Bilirubin \\< 2.0 mg/dL\n* Liver function tests (LFTs) \\< 5 x upper limit of normal (ULN)\n\nExclusion Criteria:\n\n* Graft source from bone marrow\n* Non-responders \\[progressive disease (PD) or stable disease (SD)\\] to prior anti-CD20 therapy\n* PD after ASCT\n* Post-ASCT radiotherapy\n* Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab\n* Evidence of active pneumonitis\n* Evidence of active infection\n* Concurrent prednisone or other systemic steroid medication\n* Nitrosourea therapy within 6 weeks of the first treatment with rituximab\n* Presence of anti-murine antibody (HAMA) reactivity'}, 'identificationModule': {'nctId': 'NCT00225212', 'briefTitle': "Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': "Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'protocol97'}, 'secondaryIdInfos': [{'id': '73750', 'type': 'OTHER', 'domain': 'Stanford IRB, old system'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab after ASCT', 'description': 'Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.', 'interventionNames': ['Drug: Rituximab 375 mg/m2']}], 'interventions': [{'name': 'Rituximab 375 mg/m2', 'type': 'DRUG', 'otherNames': ['Rituxan', 'MabThera', 'Zytux', 'IDEC-C2B8', 'chimeric anti-CD20'], 'armGroupLabels': ['Rituximab after ASCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Sandra J Horning, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}