Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 11:34 PM
Study NCT ID:
NCT00073957
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2003-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'C422802', 'term': 'ibritumomab tiuxetan'}], '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'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjoyce@bidmc.harvard.edu', 'phone': '617-667-9920', 'title': 'Robin Joyce, MD', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab', 'description': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 17, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate = Complete and Partial Response at 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab', 'description': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) \\> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node \\> 1 cm in short axis \\> 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab', 'description': 'Y 90 Ibritumomab Tiuxetan and Rituximab'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'This data is the best overall response achieved by patients by the 12 month period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Yttrium Y 90 Ibritumomab', 'description': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'the median time point at which a participants experienced and event or toxicity or progression', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab', 'description': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab', 'description': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Standard Phase 2'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-21', 'studyFirstSubmitDate': '2003-12-10', 'resultsFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2003-12-10', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-21', 'studyFirstPostDateStruct': {'date': '2003-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate = Complete and Partial Response at 12 Weeks.', 'timeFrame': '12 weeks', 'description': 'Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) \\> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node \\> 1 cm in short axis \\> 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy'}, {'measure': 'Best Response', 'timeFrame': '12 months', 'description': 'This data is the best overall response achieved by patients by the 12 month period.'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': '12 months', 'description': 'the median time point at which a participants experienced and event or toxicity or progression'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent adult diffuse large cell lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'anaplastic large cell lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.\n* Determine the event-free survival of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\n* Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.\n* CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29.\n* Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:\n\n * B-cell diffuse large cell variant\n * Immunoblastic\n * Mediastinal (thymic) large cell\n * T-cell/histiocyte-rich\n * Anaplastic large B-cell\n * Intravascular large B-cell\n * Lymphomatoid granulomatosis\n* Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment\n\n * Relapsed disease, defined as the following:\n\n * Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site\n * 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node\n * Progressive disease, defined as the following:\n\n * 50% increase from nadir in the SPD of any previously identified abnormal node\n * Appearance of any new lesion during or at the end of therapy\n* CD20-positive disease by immunohistochemistry\n* Bidimensionally measurable disease\n\n * At least 1 lesion at least 2.0 cm by CT scan\n* Less than 25% bone marrow involvement by lymphoma\n* No transformed lymphoma from indolent to aggressive\n* No HIV- or AIDS-related lymphoma\n* No hypocellular bone marrow\n* No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)\n* No CNS lymphoma\n* Ineligible for myeloablative therapy OR refused transplantation\n* Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Lymphocyte count no greater than 5,000/mm\\^3 (for patients with small lymphocytic lymphoma)\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than 2.0 mg/dL\n\nRenal\n\n* Creatinine no greater than 2.0 mg/dL\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 1 year after study participation\n* No concurrent serious nonmalignant disease or infection that would preclude study participation\n* No human antimurine antibody reactivity\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* No prior autologous bone marrow transplantation\n* No prior peripheral blood stem cell rescue\n* No prior failed stem cell collection\n* Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion\n* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radioimmunotherapy\n* No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow\n\nSurgery\n\n* More than 4 weeks since prior major surgery (except diagnostic surgery)\n\nOther\n\n* Recovered from all prior therapy\n* More than 4 weeks since prior therapy for lymphoma\n* More than 8 weeks since prior phase II investigational drugs\n* No other concurrent antineoplastic therapy"}, 'identificationModule': {'nctId': 'NCT00073957', 'briefTitle': "Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': "Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': '2003P000182'}, 'secondaryIdInfos': [{'id': 'CDR0000341437', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Y-90 Ibritumomab Tiuxetan', 'description': 'Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine', 'interventionNames': ['Biological: rituximab', 'Drug: cytarabine', 'Drug: liposomal cytarabine', 'Radiation: yttrium Y 90 ibritumomab tiuxetan']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['Rituxan'], 'armGroupLabels': ['Y-90 Ibritumomab Tiuxetan']}, {'name': 'cytarabine', 'type': 'DRUG', 'otherNames': ['cytosine arabinoside'], 'description': 'to be used for CNS prophylaxis', 'armGroupLabels': ['Y-90 Ibritumomab Tiuxetan']}, {'name': 'liposomal cytarabine', 'type': 'DRUG', 'otherNames': ['Depocyte'], 'description': 'to be used as CNS prophylaxis', 'armGroupLabels': ['Y-90 Ibritumomab Tiuxetan']}, {'name': 'yttrium Y 90 ibritumomab tiuxetan', 'type': 'RADIATION', 'otherNames': ['Zevalin'], 'armGroupLabels': ['Y-90 Ibritumomab Tiuxetan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care - Medical Center Campus', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Robin Joyce, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Robin Joyce', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}