{ "FullStudy":{ "Rank":218294, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510184", "OrgStudyIdInfo":{ "OrgStudyId":"SPI-ZEV-11-301" }, "Organization":{ "OrgFullName":"Spectrum Pharmaceuticals, Inc", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of Zevalin Versus Observation in Patients at Least 60 Yrs Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy", "OfficialTitle":"A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy" }, "StatusModule":{ "StatusVerifiedDate":"October 2017", "OverallStatus":"Terminated", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2018", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"June 2018", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 6, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 13, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 16, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 18, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Spectrum Pharmaceuticals, Inc", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in patients who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diffuse Large B-cell Lymphoma", "Follicle Center Lymphoma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"81", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Zevalin (ibritumomab tiuxetan)", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Day 1: Rituximab 250 mg/m2 intravenous infusion Days 7-9:Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg. In centers where biodistribution imaging is performed Day 1: Rituximab 250 mg/m2 intravenous infusion followed by In-111-Zevalin 185 MBq (5mCi), Days 3-4: Biodistribution imaging Days 7-9: Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Zevalin (ibritumomab tiuxetan)" ] } },{ "ArmGroupLabel":"Observation Arm", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Patients randomized to the observation (control) arm will not receive any further anti-lymphoma therapy unless they have a relapse of their disease." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Zevalin (ibritumomab tiuxetan)", "InterventionDescription":"Day 1: Rituximab 250 mg/m2 intravenous infusion Days 7-9:Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg. In centers where biodistribution imaging is performed Day 1: Rituximab 250 mg/m2 intravenous infusion followed by In-111-Zevalin 185 MBq (5mCi), Days 3-4: Biodistribution imaging Days 7-9: Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Zevalin (ibritumomab tiuxetan)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Overall Survival", "PrimaryOutcomeDescription":"The overall survival rate", "PrimaryOutcomeTimeFrame":"24 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"OS rate post randomization", "SecondaryOutcomeDescription":"Overall Survival (OS) rate post randomization", "SecondaryOutcomeTimeFrame":"24 Months" },{ "SecondaryOutcomeMeasure":"Progression-free survival", "SecondaryOutcomeDescription":"Progression-free survival (PFS)", "SecondaryOutcomeTimeFrame":"24 Months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatient is 60-years of age or older at time of randomization\nHistologically confirmed Ann Arbor stage II, III, or IV DLBCL; or FCL Grade 3B according to the REAL/WHO classification (from initial diagnosis made prior to starting R-CHOP therapy). Results from a pre R-CHOP marrow shall be available for review.\nLocal pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow upon confirmation of CR.\nA paraffin block or original slides available for confirmatory pathology review. Patients may be randomized based on the local pathology result.\nAge-adjusted IPI of 1, 2, or 3. The age adjusted IPI is defined by one point for LDH > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ECOG performance status >1.\nFirst-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or DA-EPOCH-R chemotherapy. Patients who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible.(See CRF Manual for further clarification).\nComplete remission (CR) according to the International Workshop Response Criteria for NHL described by Cheson et al (Appendix 2). after first-line treatment. CT scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the patient had involvement of the neck region by palpation / physical examination at first diagnosis.\nA negative FDG-PET scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale (Appendix 3) used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735).\nBone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for patients randomized to the Zevalin arm only.\nA WHO/ECOG performance status of 0, 1 or 2.\nAdequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 109/L.\nLife expectancy of 6 months or longer\nWritten informed consent obtained according to local guidelines\n\nExclusion Criteria:\n\nPresence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years (See CRF Manual for clarification). The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.\nPrior radioimmunotherapy, including radiation therapy for NHL, or any other NHL therapy.\nPresence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis.\nHistological transformation of low-grade NHL.\nActive hepatitis B or C. (See CRF completion manual)\nKnown history of HIV infection.\nAbnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease.\nAbnormal renal function: serum creatinine > 2.0 × ULN.\nNon-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment.\nKnown hypersensitivity to murine or chimeric antibodies or proteins\nG-CSF or GM-CSF therapy within 4 weeks prior to Zevalin or observation.\nConcurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study.\nTreatment with investigational drugs less than 4 weeks prior to Zevalin or observation.\nMajor surgery less than 4 weeks prior to Zevalin or start of observation.\nConcurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Patients on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20mg daily, stable for 4 weeks, are permissible.\nUnwillingness or inability to comply with the protocol.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Allen Lee, MD", "OverallOfficialAffiliation":"Spectrum Pharmaceuticals, Inc", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Cancer Treatment Services Arizona", "LocationCity":"Casa Grande", "LocationState":"Arizona", "LocationZip":"85122", "LocationCountry":"United States" },{ "LocationFacility":"Sutter East Bay Hospitals", "LocationCity":"Berkeley", "LocationState":"California", "LocationZip":"94704", "LocationCountry":"United States" },{ "LocationFacility":"City of Hope", "LocationCity":"Duarte", "LocationState":"California", "LocationZip":"91010", "LocationCountry":"United States" },{ "LocationFacility":"Halifax Health Medical Center", "LocationCity":"Daytona Beach", "LocationState":"Florida", "LocationZip":"32114", "LocationCountry":"United States" },{ "LocationFacility":"H. 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