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6A8","Canada","CA",{"type":62,"coordinates":603},[604,605],-114.08529,51.05011,{"lat":605,"lon":604},[608],{"name":609,"role":43,"phone":610,"phoneExt":45,"email":45},"Victor Lewis, MD","(403) 955-7203",{"facility":612,"status":78,"city":613,"state":614,"zip":615,"country":600,"countryCode":601,"cosmosGeoPoint":616,"geoPoint":620,"contacts":621},"Sick Kids (Pediatrics only)","Toronto","Ontario","M5G 1X8",{"type":62,"coordinates":617},[618,619],-79.39864,43.70643,{"lat":619,"lon":618},[622],{"name":623,"role":43,"phone":624,"phoneExt":45,"email":45},"Joerg Krueger, MD","(416) 813-7654",{"facility":626,"status":78,"city":613,"state":614,"zip":627,"country":600,"countryCode":601,"cosmosGeoPoint":628,"geoPoint":630,"contacts":631},"Princess Margaret Cancer Centre (Adults only)","M5G 2M9",{"type":62,"coordinates":629},[618,619],{"lat":619,"lon":618},[632],{"name":633,"role":43,"phone":634,"phoneExt":45,"email":45},"Igor Novitzky Basso, MD","(416) 315-1147",{"facility":636,"status":55,"city":637,"state":638,"zip":639,"country":640,"countryCode":641,"cosmosGeoPoint":642,"geoPoint":646,"contacts":45},"Centre Hospitalier Universitaire de Bordeaux (Adults only)","Pessac","Aquitaine","33600","France","FR",{"type":62,"coordinates":643},[644,645],-0.6324,44.80565,{"lat":645,"lon":644},{"facility":648,"status":55,"city":649,"state":650,"zip":651,"country":640,"countryCode":641,"cosmosGeoPoint":652,"geoPoint":656,"contacts":45},"Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)","Lille","Hauts-de-France","59037",{"type":62,"coordinates":653},[654,655],3.05512,50.63391,{"lat":655,"lon":654},{"facility":658,"status":55,"city":659,"state":660,"zip":661,"country":640,"countryCode":641,"cosmosGeoPoint":662,"geoPoint":666,"contacts":45},"Hôpital Necker-Enfants Malades (Pediatrics only)","Paris","Île-de-France Region","75015",{"type":62,"coordinates":663},[664,665],2.3488,48.85341,{"lat":665,"lon":664},{"facility":668,"status":55,"city":659,"state":660,"zip":669,"country":640,"countryCode":641,"cosmosGeoPoint":670,"geoPoint":672,"contacts":45},"Hôpital Saint Antoine (Adults only)","75571",{"type":62,"coordinates":671},[664,665],{"lat":665,"lon":664},{"facility":674,"status":55,"city":659,"state":660,"zip":675,"country":640,"countryCode":641,"cosmosGeoPoint":676,"geoPoint":678,"contacts":45},"Hôpital Universitaire Pitié Salpêtrière (Adults only)","75651",{"type":62,"coordinates":677},[664,665],{"lat":665,"lon":664},{"facility":680,"status":55,"city":681,"state":682,"zip":683,"country":684,"countryCode":685,"cosmosGeoPoint":686,"geoPoint":690,"contacts":45},"Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)","Milan","Milano","20162","Italy","IT",{"type":62,"coordinates":687},[688,689],12.59836,42.78235,{"lat":689,"lon":688},{"facility":692,"status":55,"city":693,"state":693,"zip":694,"country":684,"countryCode":685,"cosmosGeoPoint":695,"geoPoint":699,"contacts":45},"Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)","Pavia","27100",{"type":62,"coordinates":696},[697,698],9.15917,45.19205,{"lat":698,"lon":697},{"facility":701,"status":55,"city":702,"state":702,"zip":703,"country":684,"countryCode":685,"cosmosGeoPoint":704,"geoPoint":708,"contacts":45},"Fondazione Policlinico Universitario Agostino Gemelli (Adults only)","Roma","00168",{"type":62,"coordinates":705},[706,707],11.10642,44.99364,{"lat":707,"lon":706},{"facility":710,"status":55,"city":702,"state":702,"zip":711,"country":684,"countryCode":685,"cosmosGeoPoint":712,"geoPoint":714,"contacts":45},"Ospedale Pediatrico Bambino Gesu (Pediatrics only)","165",{"type":62,"coordinates":713},[706,707],{"lat":707,"lon":706},{"facility":716,"status":55,"city":717,"state":717,"zip":718,"country":684,"countryCode":685,"cosmosGeoPoint":719,"geoPoint":723,"contacts":45},"Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)","Torino","10126",{"type":62,"coordinates":720},[721,722],11.99138,44.88856,{"lat":722,"lon":721},{"facility":725,"status":78,"city":726,"state":727,"zip":728,"country":729,"countryCode":730,"cosmosGeoPoint":731,"geoPoint":735,"contacts":736},"Hospital Duran i Reynals (Adults and Pediatrics)","Badalona","BARCELONA","8908","Spain","ES",{"type":62,"coordinates":732},[733,734],2.24741,41.45004,{"lat":734,"lon":733},[737],{"name":738,"role":43,"phone":739,"phoneExt":45,"email":45},"Eva González-Barca, MD","932274778",{"facility":741,"status":78,"city":742,"state":742,"zip":743,"country":729,"countryCode":730,"cosmosGeoPoint":744,"geoPoint":748,"contacts":749},"Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)","Barcelona","08035",{"type":62,"coordinates":745},[746,747],2.15899,41.38879,{"lat":747,"lon":746},[750],{"name":751,"role":43,"phone":752,"phoneExt":753,"email":45},"Pere Barba, MD","93 274 6100","4897",{"facility":755,"status":78,"city":756,"state":757,"zip":758,"country":729,"countryCode":730,"cosmosGeoPoint":759,"geoPoint":763,"contacts":764},"Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)","Santander","Cantabria","39008",{"type":62,"coordinates":760},[761,762],-3.80493,43.46589,{"lat":762,"lon":761},[765],{"name":766,"role":43,"phone":767,"phoneExt":45,"email":45},"Lucrecia Yanez, MD","942202573",{"facility":769,"status":78,"city":770,"state":770,"zip":771,"country":729,"countryCode":730,"cosmosGeoPoint":772,"geoPoint":776,"contacts":777},"Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)","Madrid","28009",{"type":62,"coordinates":773},[774,775],-3.70256,40.4165,{"lat":775,"lon":774},[778],{"name":779,"role":43,"phone":780,"phoneExt":45,"email":45},"Rebeca Bailen, MD","91 426 98 26",{"facility":782,"status":78,"city":783,"state":729,"zip":784,"country":729,"countryCode":730,"cosmosGeoPoint":785,"geoPoint":789,"contacts":790},"University Hospital Virgen del Rocio (Adults and Pediatrics)","Seville","41013",{"type":62,"coordinates":786},[787,788],-5.97317,37.38283,{"lat":788,"lon":787},[791],{"name":792,"role":43,"phone":793,"phoneExt":45,"email":45},"Jose Perez-Simon, MD","955 013260",{"facility":795,"status":78,"city":796,"state":796,"zip":797,"country":729,"countryCode":730,"cosmosGeoPoint":798,"geoPoint":802,"contacts":803},"Hospital Universitario La Fe (Adults and Pediatrics)","Valencia","46009",{"type":62,"coordinates":799},[800,801],-0.37966,39.47391,{"lat":801,"lon":800},[804],{"name":805,"role":43,"phone":806,"phoneExt":45,"email":45},"Juan Montoro, MD","961 245 876",{"facility":808,"status":78,"city":809,"state":810,"zip":811,"country":812,"countryCode":813,"cosmosGeoPoint":814,"geoPoint":818,"contacts":819},"University Hospitals Birmingham NHS Foundation Trust (Adults only)","Birmingham","England","B15 2GW","United Kingdom","UK",{"type":62,"coordinates":815},[816,817],-1.89983,52.48142,{"lat":817,"lon":816},[820],{"name":821,"role":43,"phone":822,"phoneExt":45,"email":45},"Sridhar Chaganti, MD","1214242000",{"facility":824,"status":55,"city":825,"state":810,"zip":826,"country":812,"countryCode":813,"cosmosGeoPoint":827,"geoPoint":831,"contacts":45},"King's College Hospital NHS Foundation Trust (Adults only)","London","SE5 9RS",{"type":62,"coordinates":828},[829,830],-0.12574,51.50853,{"lat":830,"lon":829},{"facility":833,"status":78,"city":825,"state":810,"zip":834,"country":812,"countryCode":813,"cosmosGeoPoint":835,"geoPoint":837,"contacts":838},"Imperial College Healthcare NHS Trust (Adults only)","W12 0HS",{"type":62,"coordinates":836},[829,830],{"lat":830,"lon":829},[839],{"name":840,"role":43,"phone":841,"phoneExt":45,"email":45},"Eduardo Olavarria, MD","208 383 2134",{"type":843,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100316038","phase-3-a-phase-3-study-of-tabelecleucel-for-participants-with-epstein-barr-virus-associated-post-transplant-lymphoproliferative-disease-after-failure-with-rituximab-or-rituximab-and-chemotherapy-100316038",false,"NCT03394365","A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy","Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy","ALLELE","Inclusion Criteria:\n\n1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT).\n2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD.\n3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.\n4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and\u002For brain\u002Fspinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.\n5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD.\n6. Males and females of any age.\n7. Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants \\\u003C 16 years.\n8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the participant underwent transplant must be in morphologic remission.\n9. Adequate organ function.\n\n   1. Absolute neutrophil count ≥ 1000\u002FμL, (C-SOT) or ≥ 500\u002FμL (C-HCT), with or without cytokine support.\n   2. Platelet count ≥ 50,000\u002FμL, with or without transfusion or cytokine support. For C-HCT, platelet count \\\u003C 50,000\u002FμL but ≥ 20,000\u002FμL, with or without transfusion support, is permissible if the participant has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events \\[CTCAE\\], version 5.0).\n   3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each \\\u003C 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and\u002For PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction.\n10. Participant or participant's representative is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Currently active Burkitt, T-cell, NK\u002FT-cell lymphoma\u002FLPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.\n2. Daily steroids of \\> 0.5 mg\u002Fkg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis.\n3. Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.\n4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment.\n5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment.\n6. For C-HCT: active adenovirus viremia.\n7. Need for vasopressor or ventilatory support.\n8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment.\n9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT only).\n10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception.\n11. Inability to comply with study-related procedures.\n12. Any medical condition or organ system dysfunction that in the investigator';s opinion, could compromise the participant's safety or ability to complete the study.","ALL",{"count":854,"type":855},115,"ESTIMATED","INTERVENTIONAL",[858],"PHASE3","The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.",[861,862,863,864,865],"Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)","Solid Organ Transplant Complications","Lymphoproliferative Disorders","Allogeneic Hematopoietic Cell Transplant","Stem Cell Transplant Complications",[867,868,869,870,871,872,873,874,875,876,877,878,879,880,881,882,883,864,884],"Epstein-Barr Virus (EBV)-associated Lymphoproliferative Disease (LPD)","Epstein-Barr Virus (EBV)","Cytotoxic T lymphocyte (CTL)","Cancer After Transplant","Kidney transplant","Renal transplant","Liver transplant","Heart transplant","Lung transplant","Intestinal transplant","Pancreas transplant","Post-transplant Lymphoma","Solid Organ Transplant (SOT)","Bone Marrow Transplant Complications","Epstein-Barr Virus-specific Cytotoxic T Lymphocytes (EBV-CTL)","Hematopoietic Cell Transplant (HCT)","Hematopoietic Stem Cell Transplantation (HSCT)","Allogeneic, Off-The-Shelf T-cell Immunotherapy","2026-05-20",{"date":887,"type":888},"2026-05-22","ACTUAL",{"date":890,"type":888},"2017-12-29",{"date":892,"type":855},"2030-08",{"name":5,"class":6},71]