[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586428":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":11,"studyPopulation":11,"armGroups":22,"interventions":35,"overallOfficials":11,"centralContacts":43,"locations":49,"responsibleParty":105,"collaborators":11,"id":107,"slug":11,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":11,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":11,"enrollmentInfo":115,"targetDuration":11,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"VIVUS LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of infusion-related toxicities",null,"Within 24 hours post infusion",{"measure":14,"description":11,"timeFrame":15},"Evaluation of unacceptable toxicities","From start of BEAM through Day 30 post-AHCT",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":11},"NONE",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"VI-0609","EXPERIMENTAL","VI-0609 (Carmustine with Propylene Glycol)",[28],"Drug: VI-0609",{"label":30,"type":31,"description":32,"interventionNames":33},"BiCNU","ACTIVE_COMPARATOR","BiCNU (Carmustine with Ethanol)",[34],"Drug: BiCNU",[36,40],{"type":37,"name":24,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","Carmustine with Propylene Glycol",[24],{"type":37,"name":30,"description":41,"armGroupLabels":42,"otherNames":11},"Carmustine with Ethanol",[30],[44],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"VIVUS Clinical","CONTACT","+1-888-998-4887","clinical@vivus.com",[50,69,81,93],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"City of Hope Phoenix","RECRUITING","Goodyear","Arizona","85338","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-112.35821,33.43532,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":67,"phoneExt":11,"email":68},"Anna Keryan","626-218-1124","akeryan@coh.org",{"facility":70,"status":52,"city":71,"state":72,"zip":73,"country":56,"countryCode":57,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"City of Hope National Medical Center","Duarte","California","91010",{"type":59,"coordinates":75},[76,77],-117.97729,34.13945,{"lat":77,"lon":76},[80],{"name":66,"role":46,"phone":67,"phoneExt":11,"email":68},{"facility":82,"status":52,"city":83,"state":84,"zip":85,"country":56,"countryCode":57,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"City of Hope Atlanta","Newnan","Georgia","30265",{"type":59,"coordinates":87},[88,89],-84.79966,33.38067,{"lat":89,"lon":88},[92],{"name":66,"role":46,"phone":67,"phoneExt":11,"email":68},{"facility":94,"status":52,"city":95,"state":96,"zip":97,"country":56,"countryCode":57,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"City of Hope Chicago","Zion","Illinois","60099",{"type":59,"coordinates":99},[100,101],-87.83285,42.44613,{"lat":101,"lon":100},[104],{"name":66,"role":46,"phone":67,"phoneExt":11,"email":68},{"type":106,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100586428",false,"NCT06915246","A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma","A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)","Inclusion Criteria:\n\n* Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;\n* Karnofsky performance status ≥ 70%;\n* Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;\n* Candidate for AHCT consolidation therapy as assessed by their treating physician;\n* Achieved a complete or partial response;\n* Completed collection of at least 2.0 x 10\\^6 CD34 cells\u002Fkg of autologous hematopoietic progenitor cells (HPCs) by apheresis;\n* Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2;\n* Clinical laboratory and organ function criteria meeting study ranges\u002Flimits LVEF ≥ 50%; FEV1 \\> 65% of predicted measurement, DLCO ≥ 50% of predicted;\n* Seronegative for HIV Ag\u002FAb combo, HCV, active HBV, and syphilis\n\nExclusion Criteria:\n\n* Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;\n* Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records;\n* Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;\n* Myelodysplasia or any active malignancy other than HL or NHL, or \\\u003C 5 years remission from any other prior malignancy;\n* Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;\n* Persistent marrow involvement (\\>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;\n* Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;\n* Active hepatitis B or C viral infection or HBsAg positive;\n* Positive HIV antibody;","ALL","18 Years",{"count":116,"type":117},49,"ESTIMATED","INTERVENTIONAL",[120],"PHASE2","A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.",[123,124,125],"Lymphoma","Non-Hodgkin Lymphoma","Hodgkin Lymphoma",[123,127,30,128],"AHCT","Carmustine","2026-03-25",{"date":131,"type":132},"2026-03-27","ACTUAL",{"date":134,"type":132},"2025-03-12",{"date":136,"type":117},"2027-04-30",{"name":5,"class":6},4]