[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369743":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":429,"collaborators":38,"id":431,"slug":432,"hasResults":433,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":38,"eligibilityCriteria":437,"healthyVolunteers":433,"sex":438,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":38,"studyType":444,"phases":445,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":97,"whyStopped":38,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":468},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: pALL","EXPERIMENTAL","Pediatric\u002Fyoung adult patients with r\u002Fr pALL who meet the indication in the Health Authority-approved CTL019 package insert in the respective country\u002Fregion whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.",[13],"Biological: CTL019",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: r\u002Fr LBCL","Adult patients with r\u002Fr LBCL including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, that is consistent with the Health Authority-approved indication in the package insert for CTL019 in the respective country\u002Fregion whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group C: r\u002Fr NHL","Adult patients with r\u002Fr NHL in consistent with the Health Authority approved indication in the package insert for CTL019 in Japan whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","CTL019","A single intravenous (i.v.) infusion of CAR-positive viable T cells.",[9,15,19],[29],"Tisagenlecleucel",[31],{"name":32,"affiliation":32,"role":33},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","+41613241111",null,"Novartis.email@novartis.com",{"name":32,"role":36,"phone":41,"phoneExt":38,"email":39},"+81337978748",[43,57,66,74,79,88,96,108,113,122,130,139,144,153,161,170,174,183,191,199,208,217,226,234,243,252,261,269,276,284,292,301,310,314,316,318,321,323,326,334,337,340,343,351,358,366,374,382,387,395,403,408,413,421],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":38},"Novartis Investigative Site","COMPLETED","Hamilton","Ontario","L8V 5C2","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.84963,43.25011,{"lat":55,"lon":54},{"facility":44,"status":58,"city":59,"state":47,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":38},"WITHDRAWN","Ottawa","K1H 8L6",{"type":52,"coordinates":62},[63,64],-75.69812,45.41117,{"lat":64,"lon":63},{"facility":44,"status":45,"city":67,"state":47,"zip":68,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":73,"contacts":38},"Toronto","M5G 1X8",{"type":52,"coordinates":70},[71,72],-79.39864,43.70643,{"lat":72,"lon":71},{"facility":44,"status":45,"city":67,"state":47,"zip":75,"country":49,"countryCode":50,"cosmosGeoPoint":76,"geoPoint":78,"contacts":38},"M5G 2M9",{"type":52,"coordinates":77},[71,72],{"lat":72,"lon":71},{"facility":44,"status":58,"city":80,"state":81,"zip":82,"country":49,"countryCode":50,"cosmosGeoPoint":83,"geoPoint":87,"contacts":38},"Montreal","Quebec","H1T 2M4",{"type":52,"coordinates":84},[85,86],-73.58781,45.50884,{"lat":86,"lon":85},{"facility":44,"status":58,"city":89,"state":81,"zip":90,"country":49,"countryCode":50,"cosmosGeoPoint":91,"geoPoint":95,"contacts":38},"Québec","G1R 2J6",{"type":52,"coordinates":92},[93,94],-71.21454,46.81228,{"lat":94,"lon":93},{"facility":44,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":38},"RECRUITING","Nagoya","Aichi-ken","4668560","Japan","JP",{"type":52,"coordinates":104},[105,106],136.90641,35.18147,{"lat":106,"lon":105},{"facility":44,"status":97,"city":98,"state":99,"zip":109,"country":101,"countryCode":102,"cosmosGeoPoint":110,"geoPoint":112,"contacts":38},"4678602",{"type":52,"coordinates":111},[105,106],{"lat":106,"lon":105},{"facility":44,"status":97,"city":114,"state":115,"zip":116,"country":101,"countryCode":102,"cosmosGeoPoint":117,"geoPoint":121,"contacts":38},"Tōon","Ehime","7910295",{"type":52,"coordinates":118},[119,120],132.89011,33.79427,{"lat":120,"lon":119},{"facility":44,"status":97,"city":123,"state":123,"zip":124,"country":101,"countryCode":102,"cosmosGeoPoint":125,"geoPoint":129,"contacts":38},"Gifu","501-1194",{"type":52,"coordinates":126},[127,128],136.76039,35.42291,{"lat":128,"lon":127},{"facility":44,"status":97,"city":131,"state":132,"zip":133,"country":101,"countryCode":102,"cosmosGeoPoint":134,"geoPoint":138,"contacts":38},"Sapporo","Hokkaido","060-8648",{"type":52,"coordinates":135},[136,137],141.35,43.06667,{"lat":137,"lon":136},{"facility":44,"status":97,"city":131,"state":132,"zip":140,"country":101,"countryCode":102,"cosmosGeoPoint":141,"geoPoint":143,"contacts":38},"0608543",{"type":52,"coordinates":142},[136,137],{"lat":137,"lon":136},{"facility":44,"status":97,"city":145,"state":146,"zip":147,"country":101,"countryCode":102,"cosmosGeoPoint":148,"geoPoint":152,"contacts":38},"Kobe","Hyōgo","6500047",{"type":52,"coordinates":149},[150,151],135.183,34.6913,{"lat":151,"lon":150},{"facility":44,"status":97,"city":154,"state":146,"zip":155,"country":101,"countryCode":102,"cosmosGeoPoint":156,"geoPoint":160,"contacts":38},"Nishinomiya","6638501",{"type":52,"coordinates":157},[158,159],135.33199,34.71562,{"lat":159,"lon":158},{"facility":44,"status":97,"city":162,"state":163,"zip":164,"country":101,"countryCode":102,"cosmosGeoPoint":165,"geoPoint":169,"contacts":38},"Tsukuba","Ibaraki","3058576",{"type":52,"coordinates":166},[167,168],140.11667,36.08333,{"lat":168,"lon":167},{"facility":44,"status":97,"city":171,"state":172,"zip":173,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Kita-gun","Kagawa-ken","7610793",{"facility":44,"status":97,"city":175,"state":176,"zip":177,"country":101,"countryCode":102,"cosmosGeoPoint":178,"geoPoint":182,"contacts":38},"Yokohama","Kanagawa","236-0004",{"type":52,"coordinates":179},[180,181],139.65,35.43333,{"lat":181,"lon":180},{"facility":44,"status":97,"city":184,"state":184,"zip":185,"country":101,"countryCode":102,"cosmosGeoPoint":186,"geoPoint":190,"contacts":38},"Kumamoto","860-8556",{"type":52,"coordinates":187},[188,189],130.69181,32.80589,{"lat":189,"lon":188},{"facility":44,"status":97,"city":192,"state":192,"zip":193,"country":101,"countryCode":102,"cosmosGeoPoint":194,"geoPoint":198,"contacts":38},"Kyoto","602-8566",{"type":52,"coordinates":195},[196,197],135.75385,35.02107,{"lat":197,"lon":196},{"facility":44,"status":97,"city":200,"state":201,"zip":202,"country":101,"countryCode":102,"cosmosGeoPoint":203,"geoPoint":207,"contacts":38},"Tsu","Mie-ken","514-8507",{"type":52,"coordinates":204},[205,206],136.51667,34.73333,{"lat":206,"lon":205},{"facility":44,"status":97,"city":209,"state":210,"zip":211,"country":101,"countryCode":102,"cosmosGeoPoint":212,"geoPoint":216,"contacts":38},"Sendai","Miyagi","9808574",{"type":52,"coordinates":213},[214,215],140.86667,38.26667,{"lat":215,"lon":214},{"facility":44,"status":97,"city":218,"state":219,"zip":220,"country":101,"countryCode":102,"cosmosGeoPoint":221,"geoPoint":225,"contacts":38},"Matsumoto","Nagano","3908621",{"type":52,"coordinates":222},[223,224],137.96667,36.23333,{"lat":224,"lon":223},{"facility":44,"status":97,"city":227,"state":227,"zip":228,"country":101,"countryCode":102,"cosmosGeoPoint":229,"geoPoint":233,"contacts":38},"Nagasaki","852-8501",{"type":52,"coordinates":230},[231,232],129.88333,32.75,{"lat":232,"lon":231},{"facility":44,"status":97,"city":235,"state":236,"zip":237,"country":101,"countryCode":102,"cosmosGeoPoint":238,"geoPoint":242,"contacts":38},"Yufu","Oita Prefecture","8795593",{"type":52,"coordinates":239},[240,241],131.37829,33.1956,{"lat":241,"lon":240},{"facility":44,"status":97,"city":244,"state":245,"zip":246,"country":101,"countryCode":102,"cosmosGeoPoint":247,"geoPoint":251,"contacts":38},"Kurashiki","Okayama-ken","7108602",{"type":52,"coordinates":248},[249,250],133.76667,34.58333,{"lat":250,"lon":249},{"facility":44,"status":97,"city":253,"state":254,"zip":255,"country":101,"countryCode":102,"cosmosGeoPoint":256,"geoPoint":260,"contacts":38},"Izumi","Osaka","5941101",{"type":52,"coordinates":257},[258,259],135.43333,34.48333,{"lat":259,"lon":258},{"facility":44,"status":97,"city":262,"state":254,"zip":263,"country":101,"countryCode":102,"cosmosGeoPoint":264,"geoPoint":268,"contacts":38},"Izumisano","5988577",{"type":52,"coordinates":265},[266,267],135.31667,34.41667,{"lat":267,"lon":266},{"facility":44,"status":97,"city":254,"state":254,"zip":270,"country":101,"countryCode":102,"cosmosGeoPoint":271,"geoPoint":275,"contacts":38},"5418567",{"type":52,"coordinates":272},[273,274],135.50107,34.69379,{"lat":274,"lon":273},{"facility":44,"status":97,"city":277,"state":254,"zip":278,"country":101,"countryCode":102,"cosmosGeoPoint":279,"geoPoint":283,"contacts":38},"Sakai","590-0197",{"type":52,"coordinates":280},[281,282],135.46653,34.58216,{"lat":282,"lon":281},{"facility":44,"status":97,"city":285,"state":254,"zip":286,"country":101,"countryCode":102,"cosmosGeoPoint":287,"geoPoint":291,"contacts":38},"Suita","565-0871",{"type":52,"coordinates":288},[289,290],135.51567,34.76143,{"lat":290,"lon":289},{"facility":44,"status":97,"city":293,"state":294,"zip":295,"country":101,"countryCode":102,"cosmosGeoPoint":296,"geoPoint":300,"contacts":38},"Izumo","Shimane","6938501",{"type":52,"coordinates":297},[298,299],132.76667,35.36667,{"lat":299,"lon":298},{"facility":44,"status":97,"city":302,"state":303,"zip":304,"country":101,"countryCode":102,"cosmosGeoPoint":305,"geoPoint":309,"contacts":38},"Hamamatsu","Shizuoka","4313192",{"type":52,"coordinates":306},[307,308],137.73333,34.7,{"lat":308,"lon":307},{"facility":44,"status":97,"city":311,"state":312,"zip":313,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Bunkyo Ku","Tokyo","113-8655",{"facility":44,"status":97,"city":311,"state":312,"zip":315,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"1138431",{"facility":44,"status":97,"city":311,"state":312,"zip":317,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"1138677",{"facility":44,"status":97,"city":319,"state":312,"zip":320,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Bunkyo-ku","113-8603",{"facility":44,"status":97,"city":319,"state":312,"zip":322,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"1138519",{"facility":44,"status":97,"city":324,"state":312,"zip":325,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Chuo Ku","1040045",{"facility":44,"status":97,"city":327,"state":312,"zip":328,"country":101,"countryCode":102,"cosmosGeoPoint":329,"geoPoint":333,"contacts":38},"Fuchū","1838524",{"type":52,"coordinates":330},[331,332],139.48216,35.67452,{"lat":332,"lon":331},{"facility":44,"status":97,"city":335,"state":312,"zip":336,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Minato-ku","105-8471",{"facility":44,"status":97,"city":338,"state":312,"zip":339,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Setagaya-ku","1578535",{"facility":44,"status":97,"city":341,"state":312,"zip":342,"country":101,"countryCode":102,"cosmosGeoPoint":38,"geoPoint":38,"contacts":38},"Shinjuku-ku","1608582",{"facility":44,"status":97,"city":344,"state":38,"zip":345,"country":101,"countryCode":102,"cosmosGeoPoint":346,"geoPoint":350,"contacts":38},"Aomori","0308553",{"type":52,"coordinates":347},[348,349],140.73333,40.81667,{"lat":349,"lon":348},{"facility":44,"status":97,"city":352,"state":38,"zip":353,"country":101,"countryCode":102,"cosmosGeoPoint":354,"geoPoint":357,"contacts":38},"Chiba","2608677",{"type":52,"coordinates":355},[167,356],35.6,{"lat":356,"lon":167},{"facility":44,"status":97,"city":359,"state":38,"zip":360,"country":101,"countryCode":102,"cosmosGeoPoint":361,"geoPoint":365,"contacts":38},"Fukuoka","8128582",{"type":52,"coordinates":362},[363,364],130.41667,33.6,{"lat":364,"lon":363},{"facility":44,"status":97,"city":367,"state":38,"zip":368,"country":101,"countryCode":102,"cosmosGeoPoint":369,"geoPoint":373,"contacts":38},"Hiroshima","7348551",{"type":52,"coordinates":370},[371,372],132.45,34.4,{"lat":372,"lon":371},{"facility":44,"status":97,"city":375,"state":38,"zip":376,"country":101,"countryCode":102,"cosmosGeoPoint":377,"geoPoint":381,"contacts":38},"Ishikawa","9208641",{"type":52,"coordinates":378},[379,380],127.82139,26.42333,{"lat":380,"lon":379},{"facility":44,"status":97,"city":192,"state":38,"zip":383,"country":101,"countryCode":102,"cosmosGeoPoint":384,"geoPoint":386,"contacts":38},"6068507",{"type":52,"coordinates":385},[196,197],{"lat":197,"lon":196},{"facility":44,"status":97,"city":388,"state":38,"zip":389,"country":101,"countryCode":102,"cosmosGeoPoint":390,"geoPoint":394,"contacts":38},"Niigata","9518520",{"type":52,"coordinates":391},[392,393],139.04125,37.92259,{"lat":393,"lon":392},{"facility":44,"status":97,"city":396,"state":38,"zip":397,"country":101,"countryCode":102,"cosmosGeoPoint":398,"geoPoint":402,"contacts":38},"Okayama","7008558",{"type":52,"coordinates":399},[400,401],133.93333,34.65,{"lat":401,"lon":400},{"facility":44,"status":97,"city":254,"state":38,"zip":404,"country":101,"countryCode":102,"cosmosGeoPoint":405,"geoPoint":407,"contacts":38},"543-8555",{"type":52,"coordinates":406},[273,274],{"lat":274,"lon":273},{"facility":44,"status":97,"city":254,"state":38,"zip":409,"country":101,"countryCode":102,"cosmosGeoPoint":410,"geoPoint":412,"contacts":38},"5458586",{"type":52,"coordinates":411},[273,274],{"lat":274,"lon":273},{"facility":44,"status":97,"city":414,"state":38,"zip":415,"country":101,"countryCode":102,"cosmosGeoPoint":416,"geoPoint":420,"contacts":38},"Saitama","330-8777",{"type":52,"coordinates":417},[418,419],139.65657,35.90807,{"lat":419,"lon":418},{"facility":44,"status":97,"city":422,"state":38,"zip":423,"country":101,"countryCode":102,"cosmosGeoPoint":424,"geoPoint":428,"contacts":38},"Wakayama","641-8510",{"type":52,"coordinates":425},[426,427],135.16667,34.23333,{"lat":427,"lon":426},{"type":430,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100369743","phase-3-study-of-out-of-specification-for-tisagenlecleucel-100369743",false,"NCT04094311","Study of Out of Specification for Tisagenlecleucel","A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication","Key inclusion criteria:\n\n* Signed informed consent\u002Fassent must be obtained for this study prior to participation in the study.\n* Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.\n* Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country\u002Fregion.\n* OOS material has not been deemed to pose an undue safety risk to the patient.\n* Patient is suffering from a serious or life-threatening disease or condition.\n* Repeat leukapheresis is not clinically appropriate per the investigator assessment.\n\nKey exclusion criteria:\n\nFor part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:\n\n* Human immunodeficience virus (HIV) positive patients.\n* Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).\n* Patients with primary central nervous system (CNS) lymphoma.\n* History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.\n* Uncontrolled active infection or inflammation.\n* Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.\n* Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.","ALL","0 Years","100 Years",{"count":442,"type":443},200,"ESTIMATED","INTERVENTIONAL",[446],"PHASE3","This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.",[449,450],"B-cell Acute Lymphoblastic Leukemia","Diffuse Large B-cell Lymphoma",[452,453,454,455,456,457,458],"out of specification","tisagenlecleucel","acute lymphoblastic leukemia","large B-cell lymphoma","relapsed\u002Frefractory","pediatric","young adult patients","2026-06-24",{"date":461,"type":462},"2026-06-25","ACTUAL",{"date":464,"type":462},"2019-11-21",{"date":466,"type":443},"2027-03-31",{"name":32,"class":6},54]