[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-organ-transplant-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-organ-transplant-complications":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,63,91,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"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":19,"type":20},115,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30],"Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)","Solid Organ Transplant Complications","Lymphoproliferative Disorders","Allogeneic Hematopoietic Cell Transplant","Stem Cell Transplant Complications",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,29,49],"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","RECRUITING","2026-05-20",{"date":53,"type":54},"2026-05-22","ACTUAL",{"date":56,"type":54},"2017-12-29",{"date":58,"type":20},"2030-08",{"name":60,"class":61},"Pierre Fabre Medicament","INDUSTRY",71,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100592748","phase-1-phase-i-trial-on-the-safety-of-delayed-infusion-of-a-nave-t-cell-depleted-hematopoietic-graft-with-memory-t-cells-in-solid-organ-transplant-recipients-100592748","NCT06997471","Phase I Trial on the Safety of Delayed Infusion of a Naïve T Cell-Depleted Hematopoietic Graft With Memory T Cells in Solid Organ Transplant Recipients","A Phase I, Single-Center, Open-Label Trial to Assess the Safety and Tolerability of Delayed Infusion of a Naïve T Cell Depleted Hematopoietic Graft and Memory T-lymphocytes in Recipients of Solid Organ Transplantation","DUALGRAFT","Inclusion Criteria:\n\n* Pediatric patients (\\\u003C18 years old) who are candidates to receive intestinal or lung transplantation (before SOT).\n* Pediatric (\\\u003C18 years old) or adult patients (≥18 years old) who are either candidates for renal transplantation or have already undergone renal transplantation and remain candidates for subsequent HSCT.\n* Patients who provide informed consent (or their legal guardians in the case of minors) before any study-related procedures.\n* Recipients should have no active infectious disease or other medical condition that would contraindicate the combined transplantation procedure, as determined by the investigational team.\n\nExclusion Criteria:\n\n* Recipients with existing bone marrow disorders or those receiving medications known to adversely affect bone marrow function.\n* Patients with advanced organ dysfunction (hepatic, cardiac, or pulmonary) incompatible with successful combined transplantation.\n* Patients with active or uncontrolled autoimmune conditions that may interfere with transplantation and the induction of chimerism.\n* Patients with known allergies to medications or products required for conditioning or transplantation.\n* Patients with severe psychiatric or cognitive disorders that may interfere with adherence to study instructions or postoperative care.\n* Patients currently enrolled in another clinical trial that could interfere with the outcomes or safety of this study.\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n* Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and\u002For safety evaluation of the trial.","0 Years",{"count":73,"type":20},10,[75],"PHASE1","The goal of this clinical trial is to evaluate the safety and feasibility of inducing hematopoietic mixed chimerism to promote immune tolerance and potentially reduce the need for lifelong immunosuppression in pediatric and adult patients undergoing solid organ transplantation (SOT), including kidney, lung, and multivisceral transplants.\n\nThe main questions it aims to answer are:\n\n* Is it safe to infuse a naïve T cell-depleted hematopoietic graft along with memory T-lymphocytes after SOT?\n* Can this approach support immune tolerance and reduce the incidence of rejection and infection without long-term immunosuppression?\n\nParticipants will:\n\n* Undergo a solid organ transplant from a living or deceased donor.\n* Wait through a stabilization period to ensure resolution of early transplant-related complications.\n* Receive low-dose preconditioning (TLI and thymic irradiation) to prepare for hematopoietic stem cell transplantation.\n* Be infused with a graft containing CD34+ progenitor cells, memory T cells (CD45RO+), and no naïve T cells (CD45RA+); in some cases, NK cells may also be included.\n* Be followed for graft survival, immune tolerance, infection rates, and adverse events through regular clinical and immune monitoring visits.",[27,78,79],"Solid Organ Transplant Recipients","Solid Organ Transplant Rejection","2026-05-04",{"date":82,"type":54},"2026-05-08",{"date":84,"type":54},"2025-06-10",{"date":86,"type":20},"2028-06",{"name":88,"class":89},"Francisco Hernández Oliveros","OTHER",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":90},"100572221","microbiota-transplantation-in-solid-organ-transplantation-100572221","NCT06730451","Microbiota Transplantation in Solid Organ Transplantation","Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation","Inclusion Criteria:\n\n1. solid organ transplantation recipients;\n2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile) post-transplantation and so on;\n3. is willing to undergo WMT and provide written informed consent.\n\nExclusion Criteria:\n\n1. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;\n2. pregnant or lactating females;\n3. expected survival\\\u003C1 months;\n4. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;\n5. follow up less than 1-month post-WMT;\n6. other conditions judged by investigators not suitable for study participation.",{"count":99,"type":20},50,"OBSERVATIONAL","Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.",[27],[27,104,105,106],"Washed microbiota transplantation","Fecal microbiota transplantation","Diarrhea","2024-12-11",{"date":109,"type":54},"2024-12-12",{"date":111,"type":54},"2018-01-01",{"date":113,"type":20},"2028-12-31",{"name":115,"class":89},"The Second Hospital of Nanjing Medical University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":96,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":101,"conditions":125,"keywords":126,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":90},"100570548","washed-microbiota-transplantation-in-solid-organ-transplantation-100570548","NCT06708676","Washed Microbiota Transplantation in Solid Organ Transplantation","Inclusion Criteria:\n\n1. solid organ transplantation recipients;\n2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;\n3. is willing to undergo WMT and provide written informed consent;\n\nExclusion Criteria:\n\n1. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;\n2. pregnant or lactating females;\n3. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;\n4. follow up less than 1-month post-WMT;\n5. other conditions judged by investigators not suitable for study participation;",{"count":99,"type":20},[124],"NA",[27],[27,104,105,106,127],"Clostridium difficile","NOT_YET_RECRUITING","2024-11-24",{"date":131,"type":54},"2024-11-27",{"date":133,"type":20},"2024-11-20",{"date":135,"type":20},"2030-12-31",{"name":115,"class":89}]