{ "FullStudy":{ "Rank":218190, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511562", "OrgStudyIdInfo":{ "OrgStudyId":"CALGB-51101" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"CALGB-51101" },{ "SecondaryId":"CDR0000721927", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI Physician Data Query" },{ "SecondaryId":"NCI-2012-00110", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI Clinical Trial Reporting Program" } ] }, "Organization":{ "OrgFullName":"Alliance for Clinical Trials in Oncology", "OrgClass":"OTHER" }, "BriefTitle":"Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma", "OfficialTitle":"A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma" }, "StatusModule":{ "StatusVerifiedDate":"February 2020", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2026", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 4, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 6, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Alliance for Clinical Trials in Oncology", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Cancer Institute (NCI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.", "DetailedDescription":"Primary Objective:\n\nTo compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide\n\nSecondary Objectives:\n\nTo compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine\nTo compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine\nTo assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine\nTo determine diffusion MRI metrics (ADCmini, ADC25%, and ADCmean) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)\nTo determine brain FDG-PET metrics (tumor SUV and tumor versus background SUV) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)\nTo determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101)\nTo determine whether reduction in tumor SUV by > 25% on brain FDG-PET/CT after one cycle of induction therapy is associated with improved PFS and OS (CALGB 581101)\nTo determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113)\nTo determine which IHC-based biomarkers are predictive of a favorable prognosis (CALGB 151113) for BCL6 (B-cell CLL/lymphoma 6), and STAT 6 (signal transducer and activator of transcription 6, interleukin-4 induced)\nTo analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113)\nTo determine whether CSF proteome is a predictor of outcomes (prognostic marker) irrespective of treatment arm (CALGB 151113) for (IL-10 (interleukin 10) and C3 (complement component 3)\nTo assess the neurocognitive function of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy (etoposide and cytarabine) as measured by serial administration of the International PCNSL Collaborative Group (IPCG) neurocognitive battery and evaluate the long-term survivorship differences between the two arms (CALGB 71105)" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Lymphoma" ] }, "KeywordList":{ "Keyword":[ "primary central nervous system non-Hodgkin lymphoma", "contiguous stage II adult diffuse large cell lymphoma", "noncontiguous stage II adult diffuse large cell lymphoma", "stage I adult diffuse large cell lymphoma", "stage III adult diffuse large cell lymphoma", "stage IV adult diffuse large cell lymphoma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"113", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm I", "ArmGroupType":"Other", "ArmGroupDescription":"Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: carmustine", "Drug: thiotepa", "Procedure: stem cell transplant", "Drug: G-CSF" ] } },{ "ArmGroupLabel":"Arm II", "ArmGroupType":"Other", "ArmGroupDescription":"Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: cytarabine", "Drug: etoposide", "Drug: G-CSF" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"carmustine", "InterventionDescription":"Given IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I" ] } },{ "InterventionType":"Drug", "InterventionName":"cytarabine", "InterventionDescription":"Given IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm II" ] } },{ "InterventionType":"Drug", "InterventionName":"etoposide", "InterventionDescription":"Given IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm II" ] } },{ "InterventionType":"Drug", "InterventionName":"thiotepa", "InterventionDescription":"Given IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I" ] } },{ "InterventionType":"Procedure", "InterventionName":"stem cell transplant", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I" ] } },{ "InterventionType":"Drug", "InterventionName":"G-CSF", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm I", "Arm II" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"progression free survival", "PrimaryOutcomeTimeFrame":"Up to 10 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"event free survival", "SecondaryOutcomeTimeFrame":"Up to 10 years" },{ "SecondaryOutcomeMeasure":"number of participants with treatment-related adverse events as assessed by CTCAE v4.0", "SecondaryOutcomeTimeFrame":"Up to 10 years" },{ "SecondaryOutcomeMeasure":"overall survival", "SecondaryOutcomeTimeFrame":"Up to 10 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and vitreous fluid.\nOther Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS.\nPrevious Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma.\nAge- Patients must be between the ages of 18 and 75 years.\nKarnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70).\nPregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)\nHIV - Patients must have negative HIV serology.\nHepatitis - Patients must have negative HCV serology (unless HBsAb positive patient has recently received HBV vaccine, in this case HBcAb should be negative). All patients must be screened for hepatitis B infection before starting treatment. Those patients who test positive for hepatitis B should be closely monitored for evidence of active HBV infection and hepatitis during and for several months after rituximab treatment. PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation.\nOrgan Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy.\nRequired Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT < 2 x upper limit of normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet count ≥ 100,000/mcL", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Tracy Batchelor, MD, MPH", "OverallOfficialAffiliation":"Massachusetts General Hospital", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Anchorage Associates in 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"LocationFacility":"Katmai Oncology Group", "LocationCity":"Anchorage", "LocationState":"Alaska", "LocationZip":"99508", "LocationCountry":"United States" },{ "LocationFacility":"Providence Alaska Medical Center", "LocationCity":"Anchorage", "LocationState":"Alaska", "LocationZip":"99508", "LocationCountry":"United States" },{ "LocationFacility":"Providence Saint Joseph Medical Center/Disney Family Cancer Center", "LocationCity":"Burbank", "LocationState":"California", "LocationZip":"91505", "LocationCountry":"United States" },{ "LocationFacility":"UC San Diego Moores Cancer Center", "LocationCity":"La Jolla", "LocationState":"California", "LocationZip":"92093", "LocationCountry":"United States" },{ "LocationFacility":"University of California Davis Comprehensive Cancer Center", "LocationCity":"Sacramento", "LocationState":"California", "LocationZip":"95817", "LocationCountry":"United States" },{ "LocationFacility":"UCSF Medical Center-Mount Zion", "LocationCity":"San Francisco", 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- Fruitland", "LocationCity":"Fruitland", "LocationState":"Idaho", "LocationZip":"83619", "LocationCountry":"United States" },{ "LocationFacility":"Saint Luke's Mountain States Tumor Institute - Meridian", "LocationCity":"Meridian", "LocationState":"Idaho", "LocationZip":"83642", "LocationCountry":"United States" },{ "LocationFacility":"Saint Luke's Mountain States Tumor Institute - Nampa", "LocationCity":"Nampa", "LocationState":"Idaho", "LocationZip":"83686", "LocationCountry":"United States" },{ "LocationFacility":"Saint Luke's Mountain States Tumor Institute-Twin Falls", "LocationCity":"Twin Falls", "LocationState":"Idaho", "LocationZip":"83301", "LocationCountry":"United States" },{ "LocationFacility":"University of Illinois", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60612", "LocationCountry":"United States" },{ "LocationFacility":"University of Chicago Comprehensive Cancer Center", "LocationCity":"Chicago", "LocationState":"Illinois", 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"LocationFacility":"Lakeland Hospital", "LocationCity":"Saint Joseph", "LocationState":"Michigan", "LocationZip":"49085", "LocationCountry":"United States" },{ "LocationFacility":"Marie Yeager Cancer Center", "LocationCity":"Saint Joseph", "LocationState":"Michigan", "LocationZip":"49085", "LocationCountry":"United States" },{ "LocationFacility":"Munson Medical Center", "LocationCity":"Traverse City", "LocationState":"Michigan", "LocationZip":"49684", "LocationCountry":"United States" },{ "LocationFacility":"Metro Health Hospital", "LocationCity":"Wyoming", "LocationState":"Michigan", "LocationZip":"49519", "LocationCountry":"United States" },{ "LocationFacility":"Mayo Clinic", "LocationCity":"Rochester", "LocationState":"Minnesota", "LocationZip":"55905", "LocationCountry":"United States" },{ "LocationFacility":"Washington University School of Medicine", "LocationCity":"Saint Louis", "LocationState":"Missouri", "LocationZip":"63110", "LocationCountry":"United States" },{ 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"LocationCountry":"United States" },{ "LocationFacility":"Huntsman Cancer Institute/University of Utah", "LocationCity":"Salt Lake City", "LocationState":"Utah", "LocationZip":"84112", "LocationCountry":"United States" },{ "LocationFacility":"Central Vermont Medical Center/National Life Cancer Treatment", "LocationCity":"Berlin", "LocationState":"Vermont", "LocationZip":"05602", "LocationCountry":"United States" },{ "LocationFacility":"University of Vermont Medical Center", "LocationCity":"Burlington", "LocationState":"Vermont", "LocationZip":"05401", "LocationCountry":"United States" },{ "LocationFacility":"University of Vermont College of Medicine", "LocationCity":"Burlington", "LocationState":"Vermont", "LocationZip":"05405", "LocationCountry":"United States" },{ "LocationFacility":"Virginia Commonwealth University/Massey Cancer Center", "LocationCity":"Richmond", "LocationState":"Virginia", "LocationZip":"23298", "LocationCountry":"United States" },{ "LocationFacility":"Providence 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"LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98104", "LocationCountry":"United States" },{ "LocationFacility":"Swedish Medical Center-Ballard Campus", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98107", "LocationCountry":"United States" },{ "LocationFacility":"Fred Hutchinson Cancer Research Center", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98109", "LocationCountry":"United States" },{ "LocationFacility":"Seattle Cancer Care Alliance", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98109", "LocationCountry":"United States" },{ "LocationFacility":"Group Health Cooperative-Seattle", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98112", "LocationCountry":"United States" },{ "LocationFacility":"Swedish Medical Center-First Hill", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98122-4307", "LocationCountry":"United States" },{ 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