Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00193505
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-02', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate'}], 'secondaryOutcomes': [{'measure': 'progression-free survival'}, {'measure': 'overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Hodgkins Lymphoma']}, 'descriptionModule': {'briefSummary': "In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.", 'detailedDescription': 'Upon determination of eligibility, patients will receive:\n\n* Ifosfamide + Carboplatin + Etoposide + Rituximab\n\nPatients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be included in this study, you must meet the following criteria:\n\n* Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma\n* Persistent lymphoma after one or two previous chemotherapy regimens\n* Patients should not be considered candidates for high-dose chemotherapy\n* Ability to perform activities of daily living with assistance\n* Measurable or evaluable disease\n* Age \\> 18 years\n* Adequate bone marrow, liver and kidney function\n\nExclusion Criteria:\n\nYou cannot participate in this study if any of the following apply to you:\n\n* Patients with impaired bone marrow reserve\n* Female patients who are pregnant or lactating\n* Serious active infection at the time of treatment\n* Any other serious underlying condition\n* Brain or meningeal) with lymphoma\n* HIV or AIDS-related lymphoma\n* Received external beam radiation therapy to \\> 25% of active bone marrow.\n* History of other cancers, either active or treated\n\nPlease note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have."}, 'identificationModule': {'nctId': 'NCT00193505', 'briefTitle': 'Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'SCRI LYM 27'}, 'secondaryIdInfos': [{'id': '106-P092'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ifosfamide', 'type': 'DRUG'}, {'name': 'Carboplatin', 'type': 'DRUG'}, {'name': 'Etoposide', 'type': 'DRUG'}, {'name': 'Rituximab', 'type': 'DRUG'}, {'name': '90Y Zevalin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37023', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'John D. Hainsworth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SCRI Development Innovations, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'John Hainsworth, MD', 'oldOrganization': 'Sarah Cannon Research Institute'}}}}