[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627670":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":45,"studyPopulation":45,"armGroups":52,"interventions":61,"overallOfficials":75,"centralContacts":80,"locations":89,"responsibleParty":103,"collaborators":45,"id":106,"slug":45,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":45,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":45,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":91,"whyStopped":45,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Hospital Universitario Dr. Jose E. Gonzalez","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Determine ORR and CR after GemOx plus low-dose Epcoritamab","Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT","From enrollment to the end of treatment at 14 weeks",[14,18,22,26,29,33,37,41],{"measure":15,"description":16,"timeFrame":17},"Establish feasibility","Determine the number of subjects that complete the first cycle without need for hospitalization","From enrollment up to day 29",{"measure":19,"description":20,"timeFrame":21},"Describe cytokine release syndrome incidence","Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment","From day 1 up to day 29",{"measure":23,"description":24,"timeFrame":25},"Describe immune effector cell- associated neurotoxicity syndrome incidence","Describe the number of subjects that develop immune effector cell-associated neurotoxicity syndrome","From day 1 up to week 10",{"measure":27,"description":28,"timeFrame":25},"Describe adverse events","Describe the number of subjects that develop any adverse events",{"measure":30,"description":31,"timeFrame":32},"Determine number of patients that follow through with transplant","Determine the number of patients that go through with stem cell transplant after finishing 3 cycles of Epcoritamab + GemOx","From day one up through study completion, an average of 1 year",{"measure":34,"description":35,"timeFrame":36},"Duration of response","Determine the duration of response","From week 18 through study completion, an average of 1 year",{"measure":38,"description":39,"timeFrame":40},"Progression free survival","Report the subjects´ progression free survival","From week 18 up to six and twelve months",{"measure":42,"description":43,"timeFrame":44},"Overall survival","Report the overall survival","From day 1 to twelve months",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"NA","SINGLE_GROUP","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Epcoritamab + GemOx","EXPERIMENTAL","Subjects will receive Gemcitabine\u002FOxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.",[58,59,60],"Drug: Epcoritamab","Drug: Gemcitabine (1000 mg\u002Fm2)","Drug: Oxaliplatin",[62,67,71],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":45},"DRUG","Epcoritamab","Subjects will receive 2 step up doses of Epcoritamab (0.16 mg and 0.8 mg) followed by 12 mg weekly, for a total of three 21-day cycles (8 applications)",[54],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":45},"Gemcitabine (1000 mg\u002Fm2)","Subjects will receive gemcitabine 1000 mg\u002Fm2 on days 1 and 15 of the three 21-day cycles.",[54],{"type":63,"name":72,"description":73,"armGroupLabels":74,"otherNames":45},"Oxaliplatin","Subjects will receive oxaliplatin 100 mg\u002Fm2 on day 1 of three 21-day cycles.",[54],[76],{"name":77,"affiliation":78,"role":79},"Perla R Colunga-Pedraza, MD","Hospital Universitario \"Dr. José Eleuterio González\"","PRINCIPAL_INVESTIGATOR",[81,85],{"name":77,"role":82,"phone":83,"phoneExt":45,"email":84},"CONTACT","+52 8110761973","alrep_rcp@gmail.com",{"name":86,"role":82,"phone":87,"phoneExt":45,"email":88},"Natalia Huergo-Treviño, MD","+524442416594","nat.hue94@gmail.com",[90],{"facility":78,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":45},"RECRUITING","Monterrey","Nuevo León","64640","Mexico","MX",{"type":98,"coordinates":99},"Point",[100,101],-100.31721,25.68435,{"lat":101,"lon":100},{"type":79,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Perla Rocío Colunga Pedraza","Associated professor","100627670",false,"NCT07451652","Low Dose Epcoritamab Plus GemOx in R\u002FR DLBCL","Low Dose Epcoritamab Plus Gemcitabine\u002FOxaliplatin in Treatment of Transplant Eligible Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Subjects with relapsed\u002Frefractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant\n* ECOG 0-2\n* Women of reproductive age who agree on getting a contraceptive method\n* Subjects who fulfill Lugano´s criteria for disease activity\n* Subjects who voluntarily accept to participate in this study\n\nExclusion Criteria:\n\n* Active bacterial, viral or fungal infection\n* Subjects who have already received an autologous o allogeneic stem cell transplantation\n* Subjects with other active neoplasias\n* Subjects with end-stage failure","ALL","18 Years","65 Years",{"count":116,"type":117},10,"ESTIMATED","INTERVENTIONAL",[120],"PHASE2","In this study, researchers are looking to determine whether Gemcitabine\u002FOxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed\u002Frefractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.",[123],"Relapsed\u002FRefractory Diffuse Large B Cell Lymphoma",[125,126,127,128,129,130],"relapsed\u002Frefractory diffuse large B cell lymphoma","epcoritamab","GemOx","gemcitabine","oxaliplatin","autologous stem cell transplant","2026-03-26",{"date":133,"type":134},"2026-04-01","ACTUAL",{"date":136,"type":134},"2026-03-17",{"date":138,"type":117},"2027-09",{"name":5,"class":6},1]