[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480268":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":11,"studyPopulation":11,"armGroups":56,"interventions":73,"overallOfficials":103,"centralContacts":108,"locations":116,"responsibleParty":418,"collaborators":11,"id":420,"slug":11,"hasResults":421,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":421,"sex":427,"minAge":428,"maxAge":429,"enrollmentInfo":430,"targetDuration":11,"studyType":433,"phases":434,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":119,"whyStopped":11,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":454},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":11},[9,13,16,18],{"measure":10,"description":11,"timeFrame":12},"Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A)",null,"Up to 3 treatment cycles (cycle length = 21 days)",{"measure":14,"description":11,"timeFrame":15},"Percentage of participants with adverse events (AEs) (Arm A)","Approximately 3 years",{"measure":17,"description":11,"timeFrame":12},"Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A)",{"measure":19,"description":11,"timeFrame":20},"Serum concentration of glofitamab monotherapy (Arm B)","Up to 12 treatment cycles (Arm B) (cycle length = 21 days)",[22,25,28,31,34,37,39,42,44,46,48],{"measure":23,"description":11,"timeFrame":24},"Objective response rate (ORR) (Arms A and B)","Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)",{"measure":26,"description":11,"timeFrame":27},"Duration of complete response (DOCR) (Arm A)","From the first occurrence of a documented complete response (CR) to documented disease progression or death from any cause (whichever occurs first) (approximately 3 years)",{"measure":29,"description":11,"timeFrame":30},"Progression-free survival (PFS) (Arm A)","From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) (approximately 3 years)",{"measure":32,"description":11,"timeFrame":33},"Event-free survival (EFS) (Arm A)","From enrollment to the first occurrence of disease progression, death from any cause, or start of new anti-lymphoma therapy (not including planned hematopoietic stem cell transplantation (HSCT)) (approximately 3 years)",{"measure":35,"description":11,"timeFrame":36},"Overall survival (OS) (Arms A and B)","From enrollment to the date of death from any cause (Arm A = approximately 3 years, Arm B = approximately 4 years)",{"measure":38,"description":11,"timeFrame":12},"Percentage of participants who proceed to HSCT after up to three cycles of treatment (Arm A)",{"measure":40,"description":11,"timeFrame":41},"Duration of response (DOR) (Arm B)","From the first occurrence of a documented CR or partial response (PR) until documented disease progression or death from any cause, whichever occurs first (approximately 4 years)",{"measure":43,"description":11,"timeFrame":15},"Percentage of participants with AEs (arm B)",{"measure":45,"description":11,"timeFrame":24},"Serum concentration of obinutuzumab (Arms A and B)",{"measure":47,"description":11,"timeFrame":12},"Serum concentration of rituximab (Arm A)",{"measure":49,"description":11,"timeFrame":12},"Percentage of participants with anti-drug antibodies (ADAs) (Arms A and B)",{"allocation":51,"interventionModel":52,"interventionModelDescription":11,"primaryPurpose":53,"observationalModel":11,"timePerspective":11,"maskingInfo":54},"NA","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":11,"whoMasked":11},"NONE",[57,69],{"label":58,"type":59,"description":60,"interventionNames":61},"Arm A","EXPERIMENTAL","Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).",[62,63,64,65,66,67,68],"Drug: Obinutuzumab","Drug: Glofitamab","Drug: Rituximab","Drug: Ifosfamide","Drug: Carboplatin","Drug: Etoposide","Drug: Tocilizumab",{"label":70,"type":59,"description":71,"interventionNames":72},"Arm B","Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).",[62,63,68],[74,79,83,87,91,95,99],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":11},"DRUG","Obinutuzumab","Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)",[58,70],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":11},"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)",[58,70],{"type":75,"name":84,"description":85,"armGroupLabels":86,"otherNames":11},"Rituximab","Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)",[58],{"type":75,"name":88,"description":89,"armGroupLabels":90,"otherNames":11},"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)",[58],{"type":75,"name":92,"description":93,"armGroupLabels":94,"otherNames":11},"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)",[58],{"type":75,"name":96,"description":97,"armGroupLabels":98,"otherNames":11},"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)",[58],{"type":75,"name":100,"description":101,"armGroupLabels":102,"otherNames":11},"Tocilizumab","Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events",[58,70],[104],{"name":105,"affiliation":106,"role":107},"Clinical Trials","Hoffmann-LaRoche","STUDY_DIRECTOR",[109,114],{"name":110,"role":111,"phone":112,"phoneExt":11,"email":113},"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":115,"role":111,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[117,131,141,147,156,165,175,185,195,204,214,226,236,248,257,268,277,286,296,307,318,327,338,349,361,371,382,392,398,409],{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":11},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":126,"coordinates":127},"Point",[128,129],-86.80249,33.52066,{"lat":129,"lon":128},{"facility":132,"status":119,"city":133,"state":134,"zip":135,"country":123,"countryCode":124,"cosmosGeoPoint":136,"geoPoint":140,"contacts":11},"UCSF Benioff Children's Hospital Oakland","Oakland","California","94609",{"type":126,"coordinates":137},[138,139],-122.2708,37.80437,{"lat":139,"lon":138},{"facility":142,"status":119,"city":133,"state":134,"zip":143,"country":123,"countryCode":124,"cosmosGeoPoint":144,"geoPoint":146,"contacts":11},"Kaiser Permanente Oakland Medical Center","94611",{"type":126,"coordinates":145},[138,139],{"lat":139,"lon":138},{"facility":148,"status":119,"city":149,"state":134,"zip":150,"country":123,"countryCode":124,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Kaiser Permanente - Roseville","Roseville","95661",{"type":126,"coordinates":152},[153,154],-121.28801,38.75212,{"lat":154,"lon":153},{"facility":157,"status":119,"city":158,"state":134,"zip":159,"country":123,"countryCode":124,"cosmosGeoPoint":160,"geoPoint":164,"contacts":11},"Kaiser Permanente - Santa Clara","Santa Clara","95051",{"type":126,"coordinates":161},[162,163],-121.95524,37.35411,{"lat":163,"lon":162},{"facility":166,"status":119,"city":167,"state":168,"zip":169,"country":123,"countryCode":124,"cosmosGeoPoint":170,"geoPoint":174,"contacts":11},"Johns Hopkins University","Baltimore","Maryland","21231",{"type":126,"coordinates":171},[172,173],-76.61219,39.29038,{"lat":173,"lon":172},{"facility":176,"status":119,"city":177,"state":178,"zip":179,"country":123,"countryCode":124,"cosmosGeoPoint":180,"geoPoint":184,"contacts":11},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"type":126,"coordinates":181},[182,183],-71.05977,42.35843,{"lat":183,"lon":182},{"facility":186,"status":119,"city":187,"state":188,"zip":189,"country":123,"countryCode":124,"cosmosGeoPoint":190,"geoPoint":194,"contacts":11},"Childrens Mercy Hosp & Clinics","Kansas City","Missouri","64108",{"type":126,"coordinates":191},[192,193],-94.57857,39.09973,{"lat":193,"lon":192},{"facility":196,"status":119,"city":197,"state":197,"zip":198,"country":123,"countryCode":124,"cosmosGeoPoint":199,"geoPoint":203,"contacts":11},"MSKCC","New York","10065",{"type":126,"coordinates":200},[201,202],-74.00597,40.71427,{"lat":202,"lon":201},{"facility":205,"status":119,"city":206,"state":207,"zip":208,"country":123,"countryCode":124,"cosmosGeoPoint":209,"geoPoint":213,"contacts":11},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":126,"coordinates":210},[211,212],-84.51439,39.12711,{"lat":212,"lon":211},{"facility":215,"status":119,"city":216,"state":217,"zip":218,"country":219,"countryCode":220,"cosmosGeoPoint":221,"geoPoint":225,"contacts":11},"Queensland Children?s Hospital","South Brisbane","Queensland","4101","Australia","AU",{"type":126,"coordinates":222},[223,224],153.02049,-27.48034,{"lat":224,"lon":223},{"facility":227,"status":119,"city":228,"state":229,"zip":230,"country":219,"countryCode":220,"cosmosGeoPoint":231,"geoPoint":235,"contacts":11},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":126,"coordinates":232},[233,234],115.8073,-31.98184,{"lat":234,"lon":233},{"facility":237,"status":119,"city":238,"state":239,"zip":240,"country":241,"countryCode":242,"cosmosGeoPoint":243,"geoPoint":247,"contacts":11},"Hospital Erasto Gaertner","Curitiba","Paraná","81520-060","Brazil","BR",{"type":126,"coordinates":244},[245,246],-49.27306,-25.42778,{"lat":246,"lon":245},{"facility":249,"status":119,"city":250,"state":250,"zip":251,"country":241,"countryCode":242,"cosmosGeoPoint":252,"geoPoint":256,"contacts":11},"Graacc-Grupo de Apoio ao adolescente e a crianca com cancer","São Paulo","04023-062",{"type":126,"coordinates":253},[254,255],-46.63611,-23.5475,{"lat":255,"lon":254},{"facility":258,"status":119,"city":259,"state":11,"zip":260,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":11},"West China Second University Hospital","Chengdu","610041","China","CN",{"type":126,"coordinates":264},[265,266],104.06667,30.66667,{"lat":266,"lon":265},{"facility":269,"status":119,"city":270,"state":11,"zip":271,"country":261,"countryCode":262,"cosmosGeoPoint":272,"geoPoint":276,"contacts":11},"Sun Yet-sen University Cancer Center","Guangzhou","510060",{"type":126,"coordinates":273},[274,275],113.25,23.11667,{"lat":275,"lon":274},{"facility":278,"status":119,"city":279,"state":11,"zip":280,"country":261,"countryCode":262,"cosmosGeoPoint":281,"geoPoint":285,"contacts":11},"Guangxi Cancer Hospital of Guangxi Medical University","Nanning","530201",{"type":126,"coordinates":282},[283,284],108.31667,22.81667,{"lat":284,"lon":283},{"facility":287,"status":119,"city":288,"state":11,"zip":289,"country":290,"countryCode":11,"cosmosGeoPoint":291,"geoPoint":295,"contacts":11},"Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie","Prague","150 06","Czechia",{"type":126,"coordinates":292},[293,294],14.42076,50.08804,{"lat":294,"lon":293},{"facility":297,"status":119,"city":298,"state":11,"zip":299,"country":300,"countryCode":301,"cosmosGeoPoint":302,"geoPoint":306,"contacts":11},"Rigshospitalet","København Ø","2100","Denmark","DK",{"type":126,"coordinates":303},[304,305],12.56862,55.70968,{"lat":305,"lon":304},{"facility":308,"status":119,"city":309,"state":11,"zip":310,"country":311,"countryCode":312,"cosmosGeoPoint":313,"geoPoint":317,"contacts":11},"Hôpital Pellegrin","Bordeaux","33076","France","FR",{"type":126,"coordinates":314},[315,316],-0.58046,44.84124,{"lat":316,"lon":315},{"facility":319,"status":119,"city":320,"state":11,"zip":321,"country":311,"countryCode":312,"cosmosGeoPoint":322,"geoPoint":326,"contacts":11},"Gustave Roussy","Villejuif","94800",{"type":126,"coordinates":323},[324,325],2.35992,48.7939,{"lat":325,"lon":324},{"facility":328,"status":119,"city":329,"state":11,"zip":330,"country":331,"countryCode":332,"cosmosGeoPoint":333,"geoPoint":337,"contacts":11},"Universitaetsklinikum Muenster","Münster","48149","Germany","DE",{"type":126,"coordinates":334},[335,336],7.62571,51.96236,{"lat":336,"lon":335},{"facility":339,"status":119,"city":340,"state":11,"zip":341,"country":342,"countryCode":343,"cosmosGeoPoint":344,"geoPoint":348,"contacts":11},"Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika","Budapest","1097","Hungary","HU",{"type":126,"coordinates":345},[346,347],19.04045,47.49835,{"lat":347,"lon":346},{"facility":350,"status":119,"city":351,"state":352,"zip":353,"country":354,"countryCode":355,"cosmosGeoPoint":356,"geoPoint":360,"contacts":11},"IRCCS Ospedale Pediatrico Bambino Gesù","Rome","Lazio","00165","Italy","IT",{"type":126,"coordinates":357},[358,359],12.51133,41.89193,{"lat":359,"lon":358},{"facility":362,"status":119,"city":363,"state":364,"zip":365,"country":354,"countryCode":355,"cosmosGeoPoint":366,"geoPoint":370,"contacts":11},"Ospedaliera Ospedale Infantile Regina Margherita","Turin","Piedmont","10126",{"type":126,"coordinates":367},[368,369],7.68682,45.07049,{"lat":369,"lon":368},{"facility":372,"status":119,"city":373,"state":11,"zip":374,"country":375,"countryCode":376,"cosmosGeoPoint":377,"geoPoint":381,"contacts":11},"Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu","Wroclaw","50-556","Poland","PL",{"type":126,"coordinates":378},[379,380],17.03006,51.10286,{"lat":380,"lon":379},{"facility":383,"status":119,"city":384,"state":11,"zip":385,"country":386,"countryCode":11,"cosmosGeoPoint":387,"geoPoint":391,"contacts":11},"Seoul National University Hospital- Pediatric Site","Seoul","03080","South Korea",{"type":126,"coordinates":388},[389,390],126.9784,37.566,{"lat":390,"lon":389},{"facility":393,"status":119,"city":384,"state":11,"zip":394,"country":386,"countryCode":11,"cosmosGeoPoint":395,"geoPoint":397,"contacts":11},"Asan Medical Center","05505",{"type":126,"coordinates":396},[389,390],{"lat":390,"lon":389},{"facility":399,"status":119,"city":400,"state":11,"zip":401,"country":402,"countryCode":403,"cosmosGeoPoint":404,"geoPoint":408,"contacts":11},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":126,"coordinates":405},[406,407],2.15899,41.38879,{"lat":407,"lon":406},{"facility":410,"status":119,"city":411,"state":11,"zip":412,"country":402,"countryCode":403,"cosmosGeoPoint":413,"geoPoint":417,"contacts":11},"Hospital Infantil Universitario Niño Jesus","Madrid","28009",{"type":126,"coordinates":414},[415,416],-3.70256,40.4165,{"lat":416,"lon":415},{"type":419,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":431,"type":432},65,"ESTIMATED","INTERVENTIONAL",[435,436],"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).",[439],"Mature B-Cell Non-Hodgkin Lymphoma",[441,442,443,444],"Relapsed","Refractory","Pediatrics","B-NHL","2026-07-01",{"date":447,"type":448},"2026-07-02","ACTUAL",{"date":450,"type":448},"2022-11-16",{"date":452,"type":432},"2032-11-30",{"name":5,"class":6},30]