[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480268":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":55,"centralContacts":60,"locations":68,"responsibleParty":370,"collaborators":30,"id":372,"slug":373,"hasResults":374,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":374,"sex":380,"minAge":381,"maxAge":382,"enrollmentInfo":383,"targetDuration":30,"studyType":386,"phases":387,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":71,"whyStopped":30,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).",[13,14,15,16,17,18,19],"Drug: Obinutuzumab","Drug: Glofitamab","Drug: Rituximab","Drug: Ifosfamide","Drug: Carboplatin","Drug: Etoposide","Drug: Tocilizumab",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm B","Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).",[13,14,19],[25,31,35,39,43,47,51],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Obinutuzumab","Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)",[9,21],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Glofitamab","Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3\n\nArm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter\n\n(Cycle length = 21 days)",[9,21],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Rituximab","Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)",[9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"Ifosfamide","Participants will receive IV ifosfamide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)",[9],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"Carboplatin","Participants will receive IV carboplatin on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)",[9],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Etoposide","Participants will receive IV etoposide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)",[9],{"type":26,"name":52,"description":53,"armGroupLabels":54,"otherNames":30},"Tocilizumab","Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events",[9,21],[56],{"name":57,"affiliation":58,"role":59},"Clinical Trials","Hoffmann-LaRoche","STUDY_DIRECTOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":30,"email":65},"Reference Study ID Number: CO43810 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":67,"role":63,"phone":30,"phoneExt":30,"email":30},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[69,83,93,99,108,117,127,137,147,156,166,178,188,200,209,220,229,238,248,259,270,279,290,301,313,323,334,344,350,361],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":30},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-86.80249,33.52066,{"lat":81,"lon":80},{"facility":84,"status":71,"city":85,"state":86,"zip":87,"country":75,"countryCode":76,"cosmosGeoPoint":88,"geoPoint":92,"contacts":30},"UCSF Benioff Children's Hospital Oakland","Oakland","California","94609",{"type":78,"coordinates":89},[90,91],-122.2708,37.80437,{"lat":91,"lon":90},{"facility":94,"status":71,"city":85,"state":86,"zip":95,"country":75,"countryCode":76,"cosmosGeoPoint":96,"geoPoint":98,"contacts":30},"Kaiser Permanente Oakland Medical Center","94611",{"type":78,"coordinates":97},[90,91],{"lat":91,"lon":90},{"facility":100,"status":71,"city":101,"state":86,"zip":102,"country":75,"countryCode":76,"cosmosGeoPoint":103,"geoPoint":107,"contacts":30},"Kaiser Permanente - Roseville","Roseville","95661",{"type":78,"coordinates":104},[105,106],-121.28801,38.75212,{"lat":106,"lon":105},{"facility":109,"status":71,"city":110,"state":86,"zip":111,"country":75,"countryCode":76,"cosmosGeoPoint":112,"geoPoint":116,"contacts":30},"Kaiser Permanente - Santa Clara","Santa Clara","95051",{"type":78,"coordinates":113},[114,115],-121.95524,37.35411,{"lat":115,"lon":114},{"facility":118,"status":71,"city":119,"state":120,"zip":121,"country":75,"countryCode":76,"cosmosGeoPoint":122,"geoPoint":126,"contacts":30},"Johns Hopkins University","Baltimore","Maryland","21231",{"type":78,"coordinates":123},[124,125],-76.61219,39.29038,{"lat":125,"lon":124},{"facility":128,"status":71,"city":129,"state":130,"zip":131,"country":75,"countryCode":76,"cosmosGeoPoint":132,"geoPoint":136,"contacts":30},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"type":78,"coordinates":133},[134,135],-71.05977,42.35843,{"lat":135,"lon":134},{"facility":138,"status":71,"city":139,"state":140,"zip":141,"country":75,"countryCode":76,"cosmosGeoPoint":142,"geoPoint":146,"contacts":30},"Childrens Mercy Hosp & Clinics","Kansas City","Missouri","64108",{"type":78,"coordinates":143},[144,145],-94.57857,39.09973,{"lat":145,"lon":144},{"facility":148,"status":71,"city":149,"state":149,"zip":150,"country":75,"countryCode":76,"cosmosGeoPoint":151,"geoPoint":155,"contacts":30},"MSKCC","New York","10065",{"type":78,"coordinates":152},[153,154],-74.00597,40.71427,{"lat":154,"lon":153},{"facility":157,"status":71,"city":158,"state":159,"zip":160,"country":75,"countryCode":76,"cosmosGeoPoint":161,"geoPoint":165,"contacts":30},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":78,"coordinates":162},[163,164],-84.51439,39.12711,{"lat":164,"lon":163},{"facility":167,"status":71,"city":168,"state":169,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":30},"Queensland Children?s Hospital","South Brisbane","Queensland","4101","Australia","AU",{"type":78,"coordinates":174},[175,176],153.02049,-27.48034,{"lat":176,"lon":175},{"facility":179,"status":71,"city":180,"state":181,"zip":182,"country":171,"countryCode":172,"cosmosGeoPoint":183,"geoPoint":187,"contacts":30},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":78,"coordinates":184},[185,186],115.8073,-31.98184,{"lat":186,"lon":185},{"facility":189,"status":71,"city":190,"state":191,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":30},"Hospital Erasto Gaertner","Curitiba","Paraná","81520-060","Brazil","BR",{"type":78,"coordinates":196},[197,198],-49.27306,-25.42778,{"lat":198,"lon":197},{"facility":201,"status":71,"city":202,"state":202,"zip":203,"country":193,"countryCode":194,"cosmosGeoPoint":204,"geoPoint":208,"contacts":30},"Graacc-Grupo de Apoio ao adolescente e a crianca com cancer","São Paulo","04023-062",{"type":78,"coordinates":205},[206,207],-46.63611,-23.5475,{"lat":207,"lon":206},{"facility":210,"status":71,"city":211,"state":30,"zip":212,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":30},"West China Second University Hospital","Chengdu","610041","China","CN",{"type":78,"coordinates":216},[217,218],104.06667,30.66667,{"lat":218,"lon":217},{"facility":221,"status":71,"city":222,"state":30,"zip":223,"country":213,"countryCode":214,"cosmosGeoPoint":224,"geoPoint":228,"contacts":30},"Sun Yet-sen University Cancer Center","Guangzhou","510060",{"type":78,"coordinates":225},[226,227],113.25,23.11667,{"lat":227,"lon":226},{"facility":230,"status":71,"city":231,"state":30,"zip":232,"country":213,"countryCode":214,"cosmosGeoPoint":233,"geoPoint":237,"contacts":30},"Guangxi Cancer Hospital of Guangxi Medical University","Nanning","530201",{"type":78,"coordinates":234},[235,236],108.31667,22.81667,{"lat":236,"lon":235},{"facility":239,"status":71,"city":240,"state":30,"zip":241,"country":242,"countryCode":30,"cosmosGeoPoint":243,"geoPoint":247,"contacts":30},"Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie","Prague","150 06","Czechia",{"type":78,"coordinates":244},[245,246],14.42076,50.08804,{"lat":246,"lon":245},{"facility":249,"status":71,"city":250,"state":30,"zip":251,"country":252,"countryCode":253,"cosmosGeoPoint":254,"geoPoint":258,"contacts":30},"Rigshospitalet","København Ø","2100","Denmark","DK",{"type":78,"coordinates":255},[256,257],12.56862,55.70968,{"lat":257,"lon":256},{"facility":260,"status":71,"city":261,"state":30,"zip":262,"country":263,"countryCode":264,"cosmosGeoPoint":265,"geoPoint":269,"contacts":30},"Hôpital Pellegrin","Bordeaux","33076","France","FR",{"type":78,"coordinates":266},[267,268],-0.58046,44.84124,{"lat":268,"lon":267},{"facility":271,"status":71,"city":272,"state":30,"zip":273,"country":263,"countryCode":264,"cosmosGeoPoint":274,"geoPoint":278,"contacts":30},"Gustave Roussy","Villejuif","94800",{"type":78,"coordinates":275},[276,277],2.35992,48.7939,{"lat":277,"lon":276},{"facility":280,"status":71,"city":281,"state":30,"zip":282,"country":283,"countryCode":284,"cosmosGeoPoint":285,"geoPoint":289,"contacts":30},"Universitaetsklinikum Muenster","Münster","48149","Germany","DE",{"type":78,"coordinates":286},[287,288],7.62571,51.96236,{"lat":288,"lon":287},{"facility":291,"status":71,"city":292,"state":30,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":30},"Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika","Budapest","1097","Hungary","HU",{"type":78,"coordinates":297},[298,299],19.04045,47.49835,{"lat":299,"lon":298},{"facility":302,"status":71,"city":303,"state":304,"zip":305,"country":306,"countryCode":307,"cosmosGeoPoint":308,"geoPoint":312,"contacts":30},"IRCCS Ospedale Pediatrico Bambino Gesù","Rome","Lazio","00165","Italy","IT",{"type":78,"coordinates":309},[310,311],12.51133,41.89193,{"lat":311,"lon":310},{"facility":314,"status":71,"city":315,"state":316,"zip":317,"country":306,"countryCode":307,"cosmosGeoPoint":318,"geoPoint":322,"contacts":30},"Ospedaliera Ospedale Infantile Regina Margherita","Turin","Piedmont","10126",{"type":78,"coordinates":319},[320,321],7.68682,45.07049,{"lat":321,"lon":320},{"facility":324,"status":71,"city":325,"state":30,"zip":326,"country":327,"countryCode":328,"cosmosGeoPoint":329,"geoPoint":333,"contacts":30},"Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu","Wroclaw","50-556","Poland","PL",{"type":78,"coordinates":330},[331,332],17.03006,51.10286,{"lat":332,"lon":331},{"facility":335,"status":71,"city":336,"state":30,"zip":337,"country":338,"countryCode":30,"cosmosGeoPoint":339,"geoPoint":343,"contacts":30},"Seoul National University Hospital- Pediatric Site","Seoul","03080","South Korea",{"type":78,"coordinates":340},[341,342],126.9784,37.566,{"lat":342,"lon":341},{"facility":345,"status":71,"city":336,"state":30,"zip":346,"country":338,"countryCode":30,"cosmosGeoPoint":347,"geoPoint":349,"contacts":30},"Asan Medical Center","05505",{"type":78,"coordinates":348},[341,342],{"lat":342,"lon":341},{"facility":351,"status":71,"city":352,"state":30,"zip":353,"country":354,"countryCode":355,"cosmosGeoPoint":356,"geoPoint":360,"contacts":30},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":78,"coordinates":357},[358,359],2.15899,41.38879,{"lat":359,"lon":358},{"facility":362,"status":71,"city":363,"state":30,"zip":364,"country":354,"countryCode":355,"cosmosGeoPoint":365,"geoPoint":369,"contacts":30},"Hospital Infantil Universitario Niño Jesus","Madrid","28009",{"type":78,"coordinates":366},[367,368],-3.70256,40.4165,{"lat":368,"lon":367},{"type":371,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100480268","phase-1-a-study-to-evaluate-glofitamab-monotherapy-and-glofitamab--chemoimmunotherapy-in-pediatric-and-young-adult-participants-with-relapsedrefractory-mature-b-cell-non-hodgkin-lymphoma-100480268",false,"NCT05533775","A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed\u002FRefractory Mature B-Cell Non-Hodgkin Lymphoma","A Phase I\u002FII, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed\u002FRefractory Mature B-Cell Non-Hodgkin Lymphoma","iMATRIX GLO","Inclusion Criteria:\n\n* Age 6 months to \\\u003C 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to \\\u003C 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study\n* Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R\u002FR disease for Cohort A and second or greater R\u002FR disease for Cohort B\n* Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B\n* Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as \\> 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates\n* Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants \\\u003C 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%\n* Adequate bone marrow, liver, and renal function\n* Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)\n* Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months\n* Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment\n* Participants and\u002For caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods\n\nExclusion Criteria:\n\n* Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma\n* Receipt of glofitamab prior to study enrollment\n* Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)\n* Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy\n* Participants with active infections which are not resolved prior to Day 1 of Cycle 1\n* Prior solid organ transplantation\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)\n* Active autoimmune disease requiring treatment\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)\n* History of confirmed progressive multifocal leukoencephalopathy\n* Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results\n* Major surgery or significant traumatic injury \\\u003C 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment\n* Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment\n* Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug","ALL","6 Months","30 Years",{"count":384,"type":385},65,"ESTIMATED","INTERVENTIONAL",[388,389],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R\u002FR) mature B-cell non-Hodgkin lymphoma (B-NHL).",[392],"Mature B-Cell Non-Hodgkin Lymphoma",[394,395,396,397],"Relapsed","Refractory","Pediatrics","B-NHL","2026-07-01",{"date":400,"type":401},"2026-07-02","ACTUAL",{"date":403,"type":401},"2022-11-16",{"date":405,"type":385},"2032-11-30",{"name":5,"class":6},30]