[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytomegalovirus-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytomegalovirus-infections":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,46,71,99,125,151,177,202,224,248,274,302,335,361,384,406,426,449,478,507,531,554,589,609,631],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100457294","ganciclovir-resistantrefractory-cytomegalovirus-infection-in-sot-recipients-and-hsct-patients-100457294",false,"NCT05234723","Ganciclovir Resistant\u002FRefractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients","Epidemiological Burden of and Risk Factors for Ganciclovir Resistant\u002FRefractory Cytomegalovirus in Solid Organ Transplant and Hematopoietic Stem Cell Transplant Patients: Multicentre Cohort Study","ReCySOHT","Inclusion Criteria:\n\n* All adult (≥ 18 years) patients who underwent SOT or HSCT developing CMV-infection treated with GC\u002FVGC\n* Ability to understand the purpose of the study and provide signed and dated informed consent\n\nExclusion Criteria:\n\n* Lack of clinical and\u002For laboratory data regarding the type of CMV event\n* Lack of the serological mismatch at transplantation\n* Lack of the type of SOT or HSCT\n* Lack of the patient and graft outcome at 30, 60 or 90 days after CMV event diagnosis","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The ReCySOHT study is a multicenter, retrospective, observational case-control study on the risk factors for developing a ganciclovir-resistant\u002Frefractory (GCV-RR) cytomegalovirus infection in patients receiving solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT). Aims of the study are to investigate the incidence of and risk factors for GCV-RR CMV infection in SOT recipients and HSCT patients in order to design further studies aimed at preventing and improving the patient management of GCV-RR CMV infections.",[25],"Cytomegalovirus Infections",[27,28,29,30,31,32],"Ganciclovir-resistant CMV","Cytomegalovirus","Solid Organ Transplant","Ganciclovir","Ganciclovir-refractory CMV","Hematopoietic Stem Cell Transplant","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2023-06-19",{"date":41,"type":21},"2028-02-28",{"name":43,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",23,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100547381","phase-3-letermovir-prevymis-for-cmv-in-kidney-and-pancreas-transplant-recipients-100547381","NCT06407232","Letermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients","An Interventional Study of Letermovir for Secondary Prophylaxis After Treatment of Cytomegalovirus Infection in High Risk (D+\u002FR-) Kidney and Kidney\u002FPancreas Transplant Recipients","Inclusion Criteria:\n\n* undergone kidney or simultaneous kidney\u002Fpancreas transplant\n* high-risk CMV serostatus (D+\u002FR-) at time of transplant\n* develop CMV viremia that necessitates treatment per our institutional protocol (enrolled in the CMV stewardship monitoring initiative)\n* demonstrate proven or presumptive lack of CMI, either by CMI testing or risk factor screening\n* able to provide informed consent to participate\n\nExclusion Criteria:\n\n* contraindication to letermovir or its excipients\n* develop ganciclovir-resistant CMV infection\n* currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent\n* unable or unwilling, in the opinion of the Investigator, to comply with the protocol\n* pregnant or breastfeeding",{"count":54,"type":21},90,"INTERVENTIONAL",[57],"PHASE3","This study is designed to assess how effective letermovir is in preventing recurrence of cytomegalovirus (CMV) infection in adult kidney or kidney\u002Fpancreas transplant recipients who are UW Health patients. Participants will be in the study for about 6 months.",[25,60,61],"Kidney Transplant Infection","Pancreas Transplant","2026-06-09",{"date":34,"type":37},{"date":65,"type":37},"2024-08-08",{"date":67,"type":21},"2027-08",{"name":69,"class":44},"University of Wisconsin, Madison",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":70},"100453357","phase-1-r-mvst-cells-for-treatment-of-viral-infections-100453357","NCT05183490","R-MVST Cells for Treatment of Viral Infections","Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells","Recipient Inclusion Criteria:\n\n* Men and women ages 18 years or older of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nRecipient Exclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosupressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n\nDonor inclusion and exclusion criteria will be followed as per the most current BMT SOP (Donor selection, Donor evaluation and Donor Deferral).",{"count":79,"type":21},36,[81],"PHASE1","The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and\u002For symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion.\n\nSecondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.",[84,25,85,86],"Epstein-Barr Virus Infections","Adenovirus","BK Virus Infection",[88,89],"Rapidly generated virus specific T cells (R-MVST)","Refractory viral reactivation","2026-06-08",{"date":92,"type":37},"2026-06-10",{"date":94,"type":37},"2022-05-03",{"date":96,"type":21},"2028-06",{"name":98,"class":44},"Columbia University",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":17,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100643095","protein-biomarkers-and-host-rna-expression-profiles-in-congenital-cytomegalovirus-infection-100643095","NCT07635368","Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection","Inclusion Criteria:\n\n1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program.\n2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period.\n3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling.\n\nExclusion Criteria:\n\n1. DBS samples not approved for research use.\n2. DBS samples with insufficient blood material for RNA expression profiling and\u002For proteomic analyses.\n3. Samples with inadequate analytical quality for molecular or proteomic analyses.",true,"0 Days","28 Days",{"count":109,"type":21},630,"This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.",[112,25,113,114,115],"Congenital Cytomegalovirus","Neonatal Infection","Sensorineural Hearing Loss","Viral Infection","2026-06-04",{"date":62,"type":37},{"date":119,"type":37},"2026-04-21",{"date":121,"type":21},"2026-12-31",{"name":123,"class":44},"Rigshospitalet, Denmark",2,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":132,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100569452","evaluation-of-software-for-interpreting-virological-results-indicated-for-the-diagnosis-of-cytomegalovirus-cmv-infection-during-pregnancy-and-intended-for-health-professionals-100569452","NCT06694428","Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals","MyCMV","Inclusion Criteria:\n\n* Pregnant woman\n* And for whom a CMV serology including the search for CMV IgG and IgM antibodies is prescribed at the Necker-Enfants Malades or Paul Brousse hospital or CHU Limoges\n* And with positive anti-CMV IgM or in the grey zone of the technique\n* And for whom the date of start of pregnancy is known\n* And who does not object to the use of their data in the context of this research\n\nExclusion Criteria: NA","FEMALE",{"count":134,"type":21},491,"Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-specific symptoms and only serology can diagnose it with certainty.\n\nThe diagnosis of CMV infection is based on the combination of 2 or 3 serological markers and the interpretation of the results is more complex than for other infections and may require additional analyses and sometimes delay the diagnosis and the implementation of secondary prevention of CMV transmission to the fetus by the administration of valaciclovir. Indeed, the effectiveness of secondary prevention is conditioned by the early administration of treatment after the maternal primary infection.\n\nThe National Reference Center for Congenital CMV Infections at Necker Hospital, in collaboration with the virology laboratory at Paul Brousse Hospital, has developed the MyCMV \"expert\" tool, which is a decision-making algorithm that allows the interpretation of CMV serology and CMV PCR results.\n\nThe hypothesis of the study is that the use and provision of this MyCMV \"expert\" tool to health professionals (biologists, midwives and obstetricians) for the interpretation of virological results could avoid a delay in diagnosis and would allow patients to be referred more quickly to a prenatal diagnosis center for appropriate management of CMV infection.\n\nThe aim of the study is to evaluate the rate of detection of primary CMV infection in the first trimester of pregnancy using the MyCMV tool compared with the reference method (results interpreted by the centre's expert investigator).",[25,137],"Maternal Primary Cytomegalovirus Infection",[139,140,141,142],"Congenital cytomegalovirus (cCMV) infection","Maternal primary cytomegalovirus infection","Maternal Screening and Diagnosis","Decision-making algorithm",{"date":90,"type":37},{"date":145,"type":37},"2025-04-04",{"date":147,"type":21},"2027-04-04",{"name":149,"class":44},"Assistance Publique - Hôpitaux de Paris",3,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":55,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":70},"100521235","phase-2-open-label-trial-of-oral-letermovir-for-cmv-prophylaxis-in-thoracic-transplant-recipients-100521235","NCT06066957","Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients","Open Label Trial of Tolerability and Efficacy of Oral Letermovir for CMV Prophylaxis Among Heart and Lung Transplant Recipients","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age is \\>=18 years on the day of transplantation.\n2. Heart or Lung transplant recipient.\n3. Donor and\u002For Recipient CMV seropositive (defined by positive IgG) within 1 year prior to transplantation.\n4. Able to start oral CMV prophylaxis within 14 days (heart graft recipients) or 28 days (lung graft recipients) of transplantation.\n5. Males at birth agree to use contraception during the treatment period, and for at least 90 days after the last dose of study treatment, and refrain from donating sperm during this period.\n6. Female at birth is not pregnant or breastfeeding. If of childbearing potential, agrees to follow the contraception guidance during the treatment period and for at least 90 days after the last dose of study treatment.\n7. A male or female subject who is of reproductive potential agrees to true abstinence or to use (or have their partner use) 1 acceptable method of birth control starting from the time of consent through 90 days after the last dose of study therapy. True abstinence is defined as abstinence in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, and vasectomy OR use of appropriate double barrier contraception as per local regulations or guidelines. Hormonal contraceptives (e.g., birth control pills, transdermal patch, or injectables) are unacceptable methods of birth control for use in this study because it is not known whether these methods are affected by co- administration of letermovir.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any prior solid organ transplant.\n2. Dual organ transplantation.\n3. Prior treated CMV infection.\n4. Unknown CMV serostatus of the donor or recipient.\n5. Suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations and\u002For acyclovir formulations.\n6. CrCl \\\u003C10 mL\u002Fminute, using Cockcroft-Gault equation, or renal replacement therapy at the time of enrollment.\n7. Child-Pugh Class C severe hepatic insufficiency at enrollment.\n8. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 5 x the upper limit of normal (ULN) or serum total bilirubin \\> 2.5 x ULN. Note: Subjects who meet this exclusion criterion may, at the discretion of the investigator, have one repeat set of relevant labs done. If the repeat value does not meet this criterion, they may continue in the enrollment process.\n9. Both moderate hepatic insufficiency AND moderate renal insufficiency. Note: Moderate hepatic insufficiency is defined as Child Pugh Class B; moderate renal insufficiency is defined as a creatinine clearance less than 50 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n10. Neutropenia, defined as absolute neutrophil count \\\u003C1,500\u002Fmicroliter, at the time of enrollment.\n11. Severe thrombocytopenia, defined as platelets \\\u003C50,000\u002Fmicroliter, at the time of enrollment.\n12. Any uncontrolled infection on the day of enrollment.\n13. Documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to enrollment, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.\n14. Documented positive result for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to enrollment with need for treatment with direct acting antiviral other than the following: glecaprevir\u002Fpibrentasvir, sofosbuvir\u002Fvelpatasvir, or elbasvir\u002Fgrazoprevir.\n15. Pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.\n16. Expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.\n17. Received within 30 days prior to enrollment or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including the following: Cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent\u002Fbiologic therapy.\n18. Heart transplant recipients received \\>14 days of IV ganciclovir or oral valganciclovir prior to initiation of study drug or plans to receive during the study any of the following anti-CMV drug therapy: ganciclovir, valganciclovir, foscarnet. Lung transplant recipients received \\>28 days of IV ganciclovir or oral valganciclovir prior to initiation of study drug or plans to receive during the study any of the following anti-CMV drug therapy: ganciclovir, valganciclovir, foscarnet.\n19. Currently participating or has participated in a study with an unapproved investigational compound within 28 days, or 5× half-life of the investigational compound whichever is longer, of initial dosing on this study.\n20. Previously participated in this study or any other study involving letermovir.\n21. Previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.\n22. For unexposed subjects, any letermovir exposure.\n23. Are unable to take medications orally by day 14 post heart transplant or by day 28 post lung transplant.",{"count":159,"type":21},80,[161],"PHASE2","Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. The study hypotheses are:\n\n1. Letermovir prophylaxis will be associated with similar rates of CMV infection as valganciclovir among heart and lung transplant recipients\n2. Letermovir will be better tolerated than valganciclovir for CMV prophylaxis in heart and lung transplant recipients, with a higher proportion of days of completed therapy with correct dosing during the planned prophylaxis period\n3. Letermovir will have a lower rate of neutropenia than valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients\n4. Incorrect renal dosing will occur less frequently with letermovir than with valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients",[25,164],"Transplant-Related Disorder",[166,167],"CMV","Thoracic Transplant","2026-06-01",{"date":170,"type":37},"2026-06-03",{"date":172,"type":37},"2024-04-04",{"date":174,"type":21},"2026-08-15",{"name":176,"class":44},"University of Pennsylvania",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":55,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100636743","phase-4-letermovir-prophylaxis-duration-guided-by-cmv-specific-t-cell-monitoring-after-allo-hsct-100636743","NCT07569653","Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.","A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.","Inclusion Criteria:\n\n1. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. CMV serostatus of the recipient is positive (R+).\n3. Aged 18 years or older.\n4. Expected survival \\> 6 months.\n5. Provision of signed informed consent.\n\nExclusion Criteria:\n\n* 1.Active CMV infection or CMV disease at the time of screening.\n\n  2.Known hypersensitivity to Letermovir or its excipients.\n\n  3.Severe hepatic or renal impairment.\n\n  4.Pregnant or breastfeeding women.",{"count":185,"type":21},120,[187],"PHASE4","The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus \\[CMV\\] infection) based on the recovery of the patient's own immune system.\n\nCytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typically given as a standard prevention for about 100 days post-transplant. However, some patients may recover their CMV-specific immunity earlier, while others may need longer protection.\n\nIn this study, researchers will use a dynamic monitoring technology (QuantiFERON-CMV) to detect the level of CMV-specific T-cells in patients. Participants will be randomly assigned to either the experimental group or the control group:\n\nExperimental Group: Letermovir discontinuation will be guided by T-cell recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.\n\nControl Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.\n\nThe study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.",[25,190,191,192],"Cytomegalovirus Disease","Hematopoietic Stem Cell Transplantation","Graft vs Host Disease","2026-05-27",{"date":168,"type":37},{"date":196,"type":37},"2025-10-30",{"date":198,"type":21},"2027-12",{"name":200,"class":44},"WeiShi",12,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":222,"locationsCount":70},"100396270","breakthrough-cmv-lung-transplant--multicentre-100396270","NCT04439916","Breakthrough CMV Lung Transplant -Multicentre","Breakthrough CMV DNAemia in CMV Seronegative Recipients of CMV Seropositive Lung Transplantation During Antiviral Prophylaxis With Valganciclovir. A Pilot Study.","Inclusion Criteria:\n\n* CMV seronegative recipients of CMV seropositive donor lung transplantation.\n* Age 18 years or older.\n* Receipt of antiviral prophylaxis with valganciclovir as per local protocol with a duration of 6 or 12 months after transplantation.\n* Monitoring of CMV DNAemia post-prophylaxis for at least 12 weeks as per local protocol.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Known allergy to ganciclovir or valganciclovir.\n* Neutropenia (\\\u003C 1.0) pre-transplantation.\n* Living-donor lung transplantation.\n* Lung re-transplantation.\n* Pre-transplant immunodeficiency",{"count":210,"type":21},40,"Cytomegalovirus (CMV) infection is the most common opportunistic infection in lung transplantation leading to direct and indirect effects that can result in life threatening complications. The risk of CMV infection is highest when the recipient of the transplant has never been in contact with CMV (negative immunity) and the donor had previous contact with CMV (positive immunity). This is called CMV mismatch. For these lung transplant patients 6 to 12 months of prophylaxis with an antiviral called Valganciclovir is recommended. This antiviral can cause side effects like bone marrow toxicity and decrease in immune cells which can result in temporarily having to stop the treatment. Starting and stopping the prophylaxis may result in the CMV becoming resistant to the medication. While taking the prophylaxis it is possible to have a breakthrough of the CMV, this is often due to the development of resistance to the antiviral. The purpose of this study is to learn more about the rate of CMV breakthrough while on prophylaxis after lung transplantation in patients who are CMV mismatch. The investigators will also look at the rates of negative side effects caused by antiviral prophylaxis in this population.",[25],[166,214,215],"Lung transplant","Valganciclovir","2026-03-12",{"date":218,"type":37},"2026-03-16",{"date":220,"type":37},"2021-01-25",{"date":198,"type":21},{"name":223,"class":44},"University of Alberta",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":55,"phases":233,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":70},"100578538","efficacy-of-extended-letermovir-prophylaxis-to-prevent-cmv-reactivation-in-high-risk-chinese-adults-undergoing-allogeneic-hsct-100578538","NCT06812598","Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic HSCT","A Clinical Study on the Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. The patients have decided to undergo an initial allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. The patients are ≥18 years old.\n3. The patients are CMV seropositive prior to transplantation.\n4. The patients have at least one high-risk factor for CMV reactivation, including:\n\n(1) Haploidentical transplantation, HLA-mismatched transplantation, or unrelated donor transplantation.\n\n(2) The primary source of stem cells is cord blood. (3) A conditioning regimen including total body irradiation (TBI). (4) A GVHD prophylaxis regimen containing alemtuzumab or high-dose anti-thymocyte globulin (ATG).\n\n5\\. The patients are able to comply with the study visit schedule, understand and agree to adhere to all protocol requirements, and have voluntarily signed the informed consent form to participate in the study.\n\n6\\. The patients have no plans for reproduction from the date of consent until 90 days after the last dose of the study treatment.\n\nExclusion Criteria:\n\n1. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. Patients with evidence of CMV viremia at any time prior to enrollment.\n3. Patients with a history of CMV end-organ disease within 6 months prior to enrollment.\n4. Patients with suspected or known allergy to letermovir or any active or inactive components of similar drugs.\n5. Patients with severe hepatic impairment (defined as Child-Pugh Class C).\n6. Patients with end-stage renal disease with a creatinine clearance \\\u003C 10 mL\u002Fmin.\n7. Patients requiring mechanical ventilation or experiencing hemodynamic instability at the time of enrollment.\n8. Patients who received any investigational drug therapy within 28 days prior to enrollment.\n9. Patients who received or plan to receive any of the following treatments within 28 days prior to enrollment or during the study: cidofovir, CMV immune globulin, or any experimental CMV antiviral drugs\u002Fbiological therapies.\n10. Patients who previously participated or are currently participating in any study involving a CMV vaccine or other CMV investigational drugs, or who plan to participate in such studies during this trial.\n11. Patients who are pregnant or breastfeeding at the time of enrollment or planning to become pregnant within 90 days after the last dose of study medication.\n12. Patients who test positive for human immunodeficiency virus antibodies (HIV-Ab) at any time prior to randomization, or who test positive for hepatitis C virus antibodies (HCV-Ab) with detectable HCV RNA, or for hepatitis B surface antigen (HBsAg) within 90 days prior to randomization. Laboratory testing for HIV, HBV, or HCV is allowed using locally acceptable methods.\n13. Patients with active solid malignancies, except for localized basal cell or squamous cell carcinoma of the skin or a condition currently under treatment (e.g., lymphoma).",{"count":232,"type":21},330,[234],"NA","After allogeneic hematopoietic stem cell transplantation (allo-HSCT), recipients are immunocompromised and at increased risk of complications, including cytomegalovirus (CMV) infection. International clinical guidelines for the management of CMV infection post-allo-HSCT recommend three main strategies: minimizing infection risk, prevention, and preemptive therapy. However, traditional antiviral agents have not been approved for CMV prophylaxis in allo-HSCT recipients and are associated with significant adverse effects and the development of resistance, leaving the CMV prevention needs of this patient population unmet. Recent studies have demonstrated that letermovir prevents potent and highly specific antiviral activity against CMV, and it has been approved for CMV prophylaxis within the first 100 days post-allo-HSCT. Furthermore, evidence suggests that extending letermovir administration up to 28 weeks further reduces the risk of CMV infection in the later post-transplant period without increasing drug-related mortality. In China, the post-allo-HSCT CMV prevention strategy faces challenges such as limited treatment options, unclear guideline recommendations, non-standardized drug usage in certain medical institutions, and insufficient monitoring. This study aims to provide robust, evidence-based support for the use of letermovir in high-risk CMV reactivation among adult allo-HSCT recipients, thereby broadening clinical treatment choices.",[25,166],[238,239],"Letermovir","Allogeneic Hematopoietic Stem Cell Transplantation","2026-01-19",{"date":242,"type":37},"2026-01-21",{"date":244,"type":37},"2024-12-16",{"date":121,"type":21},{"name":247,"class":44},"The First Affiliated Hospital of Soochow University",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":255,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":55,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100610314","phase-3-phase-3-randomized-trial-for-refractory-adv-or-cmv-infection-with-family-matched-ctls-and-standard-of-care-soc-vs-soc-alone-100610314","NCT07225972","Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone","An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection\u002FViremia","Patient Eligibility Cohort 1 (ADV) -Patients with ADV infections (Cohort 1) (pneumonitis, hepatitis, cystitis, and\u002For colitis) post AlloHSCT with one or more of the following: Increasing or persistent ADV RT-PCR DNA (\\> 1000 ADV PCR copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-viral therapies including one or more of the following: \\> grade 2 renal insufficiency secondary to cidofovir and\u002For other \\> grade 2 toxicities secondary to cidofovir AND\u002FOR Known resistance to cidofovir\n\nPatient Eligibility (Cohort 2) (CMV)\n\n-Patients with CMV infections (pneumonitis, hepatitis, colitis) with one or more of the following: Increasing or persistent CMV RT-PCR DNA (\\>1000 copies) after 7 days of appropriate anti-viral therapy AND\u002FOR Medical intolerance to anti-CMV antibiotic therapies: ANC \\> 500\u002Fmm3 secondary to ganciclovir AND\u002FOR \\> grade 2 renal toxicity secondary to either foscarnet or cidofovir AND\u002FOR Known resistance to ganciclovir and\u002For foscarnet\n\n* Consent: written informed consent given (by patient or legal representative) prior to any study related procedures\n* Performance Status \\>30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 years (BOTH COHORTS)\n* Age: 0.01 to 30.00 years (BOTH COHORTS)\n* Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS)\n\nDonor Eligibility\n\n* Related donor available with a T-cell response to the ADV MACS PepTivators (Cohort 1) or CMV MACS PepTivator (Cohort 2). As defined in Appendix II, B, 8.2, the donor is considered suitable if the percentage of IFN+ T-cells is \\>0.01% after stimulation with ADV PepTivators (Cohort 1) or CMV PepTivators (Cohort 2).\n* Third-party related allogeneic donor: If original donor is not available or does not have a T-cell response to ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2), third party allogeneic donor (family donor \\> 3 HLA A, B, DR match to recipient) with a T-cell response at least to the ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2) AND\n* Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1) AND\n* Obtained informed consents by donor or donor legally authorized representative prior to donor collection\n\nPatient Exclusion Criteria (Both Cohorts)\n\n* Patient with acute GVHD \\> grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion.\n* Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CTL infusion.\n* Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion.\n* Patient with poor performance status determined by Karnofksy (patients \\> 16 yrs) or Lansky (patients \\\u003C 16 years) score \\\u003C 30%.\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ADV or CMV infections.\n* Any known medical condition which cold compromise participation in the study according to investigators assessment.\n* Known AIDS or uncontrolled HIV infection\n* Known hypersensitivity to iron dextran\n* Encephalitis and\u002For retinitis","1 Day","30 Years",{"count":258,"type":21},69,[57],"Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.",[166,262,263,85,25],"AdV Infection","AdV Reactivation","NOT_YET_RECRUITING","2025-11-06",{"date":267,"type":37},"2025-11-10",{"date":269,"type":21},"2026-12-01",{"date":271,"type":21},"2032-12-01",{"name":273,"class":44},"New York Medical College",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":55,"phases":284,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":70},"100284461","early-phase-1-t-cell-therapy-of-opportunistic-cytomegalovirus-infection-100284461","NCT02982902","T Cell Therapy of Opportunistic Cytomegalovirus Infection","Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant","Inclusion Criteria:\n\n* Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration\n* Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)\n\n  * Patients may have asymptomatic viremia (\\>1000 copies\u002Fml) OR presence of symptoms secondary to CMV infection, AND\n  * Patients must have ONE OF THE NEXT FOUR CRITERIA:\n\n    * Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or\n    * New, persistent and\u002For worsening CMV-related symptoms, signs and\u002For markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or\n    * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.\n    * Second recurrence of CMV viremia, CMV-related symptoms, signs and\u002For markers of end organ compromise.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women are excluded from this study.\n* Patients with opportunistic viral infections other than CMV.\n* Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\\>0.5 mg\u002Fkg\u002Fday prednisone or its equivalent) as treatment\n* Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.\n* Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.\n\nDonor eligibility\n\n* Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3\u002F6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).\n* Must have evidence of a serologic response (i.e. be seropositive) against CMV.\n* Age ≥ 18 years\n* Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program\n* Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood","3 Months",{"count":283,"type":21},20,[285],"EARLY_PHASE1","The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.\n\nAdoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).",[25,32,288],"Opportunistic Infections",[290,291,292],"Immunotherapy","T-Cell Therapy","Lymphoproliferative Disorder","2025-10-20",{"date":295,"type":37},"2025-10-22",{"date":297,"type":37},"2020-05-27",{"date":299,"type":21},"2028-08",{"name":301,"class":44},"Mari Dallas",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":105,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":310,"targetDuration":312,"studyType":22,"phases":4,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":4},"100609106","hcmv-mirna-monitoring-after-allogeneic-hematopoietic-stem-cell-transplantation-using-pstm-qpcr-100609106","NCT07210242","HCMV-miRNA Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation Using PSTM-qPCR","Clinical Study on Monitoring Cytomegalovirus (HCMV) Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Using High-Performance miRNA Quantification Technology (PSTM-qPCR)","HSCT-HCMV01","Inclusion Criteria:\n\n\\- Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nStem cell source includes peripheral blood stem cells and\u002For bone marrow plus peripheral blood.\n\nAbility to understand study procedures and provide written informed consent.\n\nVoluntary participation in the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n\nChildren or individuals with severe cognitive impairment who cannot comply with blood sample collection.\n\nPatients with severe comorbidities or other medical conditions judged by the investigator to significantly interfere with study participation or follow-up.\n\nWithdrawal of informed consent during the study.\n\nClinical background or history that may introduce significant confounding effects, or when additional sampling frequency is deemed to pose undue risk to the participant.",{"count":311,"type":21},300,"12 Months","Human cytomegalovirus (HCMV) infection is one of the most common and serious complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Standard monitoring uses HCMV DNA testing, but this method may not detect the virus early enough to guide timely treatment.\n\nThis multicenter observational study will evaluate a new high-performance microRNA (miRNA) detection technology (PSTM-qPCR) for monitoring HCMV infection in allo-HSCT patients. Approximately 300 patients and their donors will be enrolled across several major transplant centers in China. Blood samples will be collected before and after transplantation to test for both HCMV-miRNA and HCMV-DNA. The study will compare the sensitivity and timing of miRNA detection with conventional DNA testing and explore whether miRNA can serve as an early biomarker of infection and related complications.\n\nThe goal is to improve early diagnosis and management of HCMV infection, reduce infection-related complications, and ultimately improve survival outcomes in patients undergoing allo-HSCT.",[25,191,315,192],"Virus Reactivation",[239,317,318,319,320,321,322,323,324,325],"Human Cytomegalovirus","MicroRNA","HCMV-miRNA","PSTM-qPCR","Viral Reactivation","Infection Monitoring","Early Diagnosis","Biomarker","GVHD","2025-09-29",{"date":328,"type":37},"2025-10-07",{"date":330,"type":21},"2025-10-10",{"date":332,"type":21},"2028-10-10",{"name":334,"class":44},"Ting YANG",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":342,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":55,"phases":345,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":150},"100585956","phase-1-viral-specific-t-lymphocytes-to-treat-infection-with-adenovirus-cytomegalovirus-or-epstein-barr-virus-in-patients-with-compromised-immunity-100585956","NCT06909110","Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity","Viral Specific T-Lymphocytes by Cytokine Capture System (CCS) to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus After Hematopoietic Cell Transplantation or Solid Organ Transplantation and in Patients With Compromised Immunity","Patient Inclusion Criteria\n\n1. Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if feasible.\n2. Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.\n3. Prior allogeneic hematopoietic stem cell transplant, AND\u002FOR prior solid organ transplant (liver, kidney, lung and\u002For heart, intestinal, pancreatic, and\u002For multivisceral), AND\u002FOR diagnosis of primary immunodeficiency AND\u002FOR current\u002Frecent administration of immunosuppressive therapy for cancer or autoimmune disease.\n4. If receiving steroids, must be able to taper dose to less than 1 mg\u002Fkg\u002Fday prednisone (or equivalent) prior to cellular infusion.\n5. Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized or post-menopausal.\n6. Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy.\n\nA. Adenovirus Infection or Disease (at minimum, one of the below sub-criteria must be met):\n\n1. Active adenovirus infection: (i.e. gastroenteritis, pneumonia, hemorrhagic cystitis, hepatitis, pancreatitis, meningitis) defined as the demonstration of adenovirus by biopsy specimen from affected site(s) (by culture or histology), or the detection of adenovirus by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)\n2. Refractory adenoviremia: defined as DNAemia ≥1000 copies\u002FmL or \\\u003C1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)\n3. Intolerance of or contraindication to antiviral medications.\n\nB. CMV Infection or Disease (at minimum, one of the below sub-criteria must be met):\n\n1. Active CMV infection: (i.e. pneumonia, meningitis, retinitis, hepatitis, hemorrhagic cystitis, and\u002For gastroenteritis) defined as the demonstration of CMV by biopsy specimen from affected site(s) (by culture or histology) or the detection of CMV by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)\n2. Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥1,000 IU\u002FmL or \\\u003C1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)\n3. Intolerance of or contraindication to antiviral medications.\n\nC. EBV Infection or Disease (at minimum, one of the below sub-criteria must be met):\n\n1. EBV DNAemia ≥1000 IU\u002FmL, persistent despite 2 doses of rituximab,\n2. Biopsy proven lymphoma or lymphoproliferative disease with EBV genomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or in situ PCR,\n3. Clinical or imaging findings consistent with EBV lymphoma or lymphoproliferation with current or recent elevated EBV viral load in peripheral blood in a patient where biopsy is deemed too high risk,\n4. Failure of antiviral therapy, as determined by one of the two bullets below after two weeks of anti-CD20 targeted therapy such as rituximab, i. There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation.\n\n   ii. There was a rise or a fall of less than 50% in EBV viral load in peripheral blood.\n5. Intolerance or contraindication to rituximab.\n\nPatient Exclusion Criteria:\n\n1. Received ATG or Alemtuzumab within 21 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by \\\u003C10 CD3+ T cells\u002FuL (in unique situations, plasmapheresis may be considered).\n2. Active acute GVHD grades II-IV.\n3. Active severe chronic GVHD.\n4. Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded.\n5. Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).\n6. Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.\n7. Patients who are pregnant or lactating.\n8. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, or concomitant medications, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.\n\nDonor Inclusion Criteria\n\n1. Age ≥ 12\\*\n2. Able to understand and sign the consent\u002Fassent to the procedure\n3. Partial (2\u002F6 or more) HLA match to the recipient\n4. A pediatric donor could be selected as a donor only if a suitable adult donor is not available (as attested by the research team) or is ineligible according to FACT requirements. For pediatric donors:\n\n   * Related to the recipient\n   * Apheresis does not need a blood prime before the procedure\n   * Adequate peripheral venous access\n   * Explicit evaluation of the donors' willingness to donate cells, as attested by the research team\n   * Must have understanding that they are helping their ill relative, as attested by the research team\n   * Will gain emotional\u002Fpsychological benefit from their ability to help and want to donate for a relative, as attested by the research team\n   * Inclusion of minor donors that are not relatives of the recipient will need to be evaluated on a case-by-case basis for the IRB to evaluate the potential benefit to these participants (whether they will receive an emotional and psychological boost from helping the recipient) \\*If the only suitable donor is less than 12 years old, a single patient exception to this inclusion criteria will be submitted and approved by the IRB before obtaining the donor's assent and their LAR consent.\n\nDonor Exclusion Criteria\n\n1. Donor is pregnant\n2. Donor is HIV positive\n3. Donor is positive for hepatitis B and\u002For hepatitis C\n4. Deemed to be a high-risk donor based on responses to donor risk questionnaire\n5. Deemed high risk due to preexisting medical condition or abnormal lab results","1 Month","65 Years",{"count":5,"type":21},[81,161],"The primary purpose of this phase I\u002FII study is to evaluate whether partially matched, ≥2\u002F6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and\u002For SOT recipients, and\u002For patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.",[85,25,84],[349,85,28,350,351,29],"Cytokine Capture System","Epstein-Barr Virus","Hematopoietic Cell Transplant","2025-08-08",{"date":354,"type":37},"2025-08-14",{"date":356,"type":37},"2025-04-30",{"date":358,"type":21},"2032-01-01",{"name":360,"class":44},"Jessie L. Alexander",{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":342,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":55,"phases":370,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100306239","phase-2-virus-specific-cytotoxic-t-lymphocytes-ctls-for-refractory-cytomegalovirus-cmv-100306239","NCT03266640","Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)","A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections With Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients","1\\. Patients with refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either\n\n* Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND\u002FOR\n* Medical intolerance to anti-viral therapies including:\n* ANC \\\u003C 500\u002Fmm2 secondary to ganciclovir\n\n  * 2 renal toxicity with foscarnet And\u002For\n* known resistance to ganciclovir and\u002For foscarnet\n\nConsent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.\n\nPerformance Status \\> 30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 yrs) Age: 0.1 to 79.99 years Females of childbearing potential with a negative urine pregnancy test\n\nDonor Eligibility Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s).\n\na. Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor \\> 1 HLA A, B, DR match to recipient) with IgG positive to CMV and\u002For a T-cell response to the CMV MACS® GMP PepTivator .\n\nAND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).\n\nAND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.\n\n3 Patient exclusion criteria:\n\nA patient meeting any of the following criteria is not eligible for the present study:\n\nPatient with acute GVHD \\> grade 2 or extensive chronic GVHD at the time of CMV CTL infusion Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of CMV CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory CMV infection.\n\nAny medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.\n\nKnown hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n\nKnown human anti-mouse antibodies CMV retinitis, meningitis, encephalitis, and\u002For cerebritis","79 Years",{"count":283,"type":21},[161],"CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.\n\nFunding Source: FDA OOPD",[25,373],"Primary Immune Deficiency Disorder",[28,166,375],"cytotoxic t-lymphocytes","2025-08-07",{"date":352,"type":37},{"date":379,"type":37},"2018-11-01",{"date":381,"type":21},"2027-12-31",{"name":273,"class":44},9,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":391,"enrollmentInfo":4,"targetDuration":4,"studyType":392,"phases":4,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":400,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":404,"locationsCount":4},"100600984","tetravi-expanded-access-program-100600984","NCT07104591","TETRAVI Expanded Access Program","Expanded Access Use of Multivirus-Specific Cytotoxic T-Lymphocytes for Pediatric Patients With EBV, CMV, Adenovirus, or BK Virus Infections Post Allogeneic Stem Cell Transplant","Inclusion Criteria:\n\n* Patients \\\u003C18 years of age.\n* Patients who have undergone myeloablative or non-myeloablative allogeneic HSCT or CAR T therapy in the Sate of Texas (USA).\n* Have persistent, increasing, or recurrent infections with EBV, CMV, adenovirus, or BK virus despite standard treatment.\n* Treating physician must be based in Texas.\n* Must obtain IRB approval and submit a protocol to FDA with Letter of Authorization from Baylor.\n\nExclusion Criteria:\n\n* Patients with active uncontrolled infections unrelated to the viruses mentioned.\n* Use of certain immunosuppressive agents within 28 days.\n* Serious uncontrolled medical conditions or relapse of underlying disease.","17 Years","EXPANDED_ACCESS","This Expanded Access Program (EAP) allows qualified physicians within Texas to obtain access to multivirus-specific cytotoxic T lymphocytes (VSTs) developed under Baylor College of Medicine's TETRAVI program (NCT04013802) for the treatment of persistent or recurrent infections with EBV, CMV, adenovirus, or BK virus in pediatric patients being treated in Texas who have received allogeneic stem cell transplants and have no other suitable therapeutic options.",[395,25,396,86,397,398,399],"Epstein-Barr Virus Infection","Adenovirus Infection","JC Virus Infection","Viral Infections Post-Transplant","Post-Allogeneic Stem Cell Transplant Complications","AVAILABLE","2025-07-29",{"date":403,"type":37},"2025-08-05",{"name":405,"class":44},"Baylor College of Medicine",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":281,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":55,"phases":416,"briefSummary":82,"conditions":417,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":70},"100587323","phase-1-r-mvst-cells-for-treatment-of-viral-infections-in-children-and-young-adults-100587323","NCT06926894","R-MVST Cells for Treatment of Viral Infections in Children and Young Adults","Single Center Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells for Immunodeficient Children and Young Adults","Inclusion Criteria:\n\n* Children and young adults (3 months to \\\u003C26 years) of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nExclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n* Unable or unwilling to receive infusions at Morgan Stanley Children's Hospital.","26 Years",{"count":415,"type":21},18,[81],[350,25,85,86,418],"Immune Deficiency",{"date":420,"type":37},"2025-07-31",{"date":422,"type":37},"2025-04-20",{"date":424,"type":21},"2030-12",{"name":98,"class":44},{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":17,"minAge":342,"maxAge":18,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":445,"leadSponsor":447,"locationsCount":70},"100593971","immunoglobiulin-specific-prophylaxis-of-citomegalovirus-infections-in-immunocompromised-children-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-100593971","NCT07013370","Immunoglobiulin-specific Prophylaxis of Citomegalovirus Infections in Immunocompromised Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Immunoglobulin-specific Prophylaxis Against Citomegalovirus Infections in Immunocompromised Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Children who underwent allogeneic HSCT due to any condition\n\nExclusion Criteria:\n\n* Positive personal records of immunoglobulin-related adverse reactions\n* CMV reactivation before the CMV-specific immunoglobulin prophylaxis onset\n* adoptive cellular post-HSCT immunotherapy for any indication",{"count":434,"type":21},150,"Human cytomegalovirus (CMV) is a globally prevalent, human-specific herpesvirus characterised by a lifelong latency after primary infection, an often asymptomatic reactivation and affecting up to 100% of adults based on region and age. CMV reactivation has serious risks for immunocompromised patients, especially those undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In these patients, CMV can lead to graft failure, multiorgan disease, increased risk of other infections, GVHD, post-transplant lymphoproliferative disorders, and higher transplant-related mortality (TRM). Although antiviral prophylaxis, CMV infection occurs in 38-80% of HSCT recipients, but current antiviral drugs are insufficiently effective and they are associated with adverse effects. Furthermore, treatment failure is due to the high genetic variability of CMV. The protective role of virus-specific antibodies remains under debate. Some studies suggest that high neutralizing antibody titers protect transplant recipients from CMV, while others highlight the importance of T-cell responses. However, recent animal studies showed that humoral immunity alone can prevent CMV reactivation, even without T or NK cells. In solid-organ transplant patients, antibody titers ≥480 have been linked to reduced infection, shorter treatment, and full protection from CMV disease. Although the use of anti-CMV immunoglobulin remains controversial, the IRCCS Burlo Garofolo has used it as post-transplant prophylaxis and second-line treatment for over a decade.\n\nThe main objective of their study was to assess whether CMV-specific immunoglobulin prophylaxis reduces CMV incidence and severity in pediatric HSCT patients. Secondary goals included evaluating its effect on transplant outcomes and its efficacy across different ethnic groups. A population pharmacokinetic (POP\u002FPK) study was also conducted to better understand the drug's distribution and elimination and to identify factors influencing its pharmacokinetics in patients.",[437,25,239,164],"Immunoglobulin Prophylaxis",[28,439,440],"allo-HSCT","Transplant-Related mortality","2025-06-02",{"date":443,"type":37},"2025-06-10",{"date":441,"type":37},{"date":446,"type":21},"2026-06-02",{"name":448,"class":44},"Antonello Di Paolo, M.D., Ph.D.",{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":55,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":124},"100364856","quantiferon-cmv-test-in-a-prediction-for-colic-cytomegalovirus-reactivation-during-ulcerative-colitis-100364856","NCT04030676","QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis","Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)","RECOHFERRON","Inclusion Criteria:\n\n* Patient with seropositive for CytoMegaloVirus (CMV) (IgG+)\n* Patient requiring hospitalization for flare of Ulcerative Colitis (UC) with Mayo score \\> 5 and an endoscopic subscore ≥ 2\n* Social security affiliation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Wardship patient and curatorial patient\n* Patient unable to understand or sign the protocol\n* Colectomy total or partial",{"count":458,"type":21},196,[234],"CytoMegaloVirus (CMV) infection impairs evolution of Ulcerative Colitis (UC) leading to more severe and resistant to immunosuppressive therapies flare-up. CytoMegaloVirus (CMV) reactivation is assessed by the quantification of the CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load by real-time PCR (qPCR) in colonic biopsies; this assay is invasive and costly. The QuantiFERON-CytoMegaloVirus (QF-CMV) assay measures the immune response against CytoMegaloVirus (CMV) in a blood specimen.",[25],[463,464,465,466,467,468],"Immune response against","QuantiFERON-CytoMegaloVirus (QF-CMV)","Ulcerative Colitis (UC)","CytoMegaloVirus (CMV)","quantitative PolymeraseChainReaction (qPCR)","ImmunoHistoChemistry (IHC)","2025-04-28",{"date":471,"type":37},"2025-04-29",{"date":473,"type":37},"2019-07-17",{"date":475,"type":21},"2026-04",{"name":477,"class":44},"Centre Hospitalier Universitaire de Saint Etienne",{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":55,"phases":487,"briefSummary":488,"conditions":489,"keywords":493,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":70},"100487395","phase-4-letermovir-for-secondary-prophylaxis-in-solid-organ-transplant-recipients-100487395","NCT05626530","Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients","A Pilot Trial of the Tolerability and Clinical Effectiveness of Letermovir When Used for Secondary Prophylaxis to Prevent Recurrent Cytomegalovirus Disease in Solid Organ Transplant Recipients","Inclusion Criteria:\n\n1. Adult (\\> 18 years old) solid organ transplant recipients (heart, kidney or liver patients) recovering from treated CMV disease in whom the clinician deems that the patient need secondary prophylaxis and in whom written informed consent is obtained.\n2. Patient able to participate with follow up for 6 months\n3. Not enrolled in competing clinical trials\n\nExclusion Criteria:\n\n1. Patients with creatinine clearance less than 10 ml per min at time of enrollment\n2. Hypersensitivity to letermovir or has a CMV isolate which is known to be resistant to letermovir based on prior testing\n3. On CVVH or renal dialysis at the time of enrollment\n4. Has Child Pugh Class C severe hepatic insufficiency at screening.\n5. Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency at screening.\n\n   Note: Moderate hepatic insufficiency is defined as Child Pugh Class B (Appendix 8); moderate to severe renal insufficiency is defined as CrCl \\\u003C50 mL\u002Fmin, as calculated by the Cockcroft-Gault equation.\n6. Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.\n7. Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.\n8. Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.\n9. Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or put the participant at undue risk, as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.\n10. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the 6 months) of drug or alcohol abuse or dependence.\n\n    Note: Participants with a history of marijuana use which is not deemed excessive by an investigator or does not interfere with the participant's daily function may participate in the study.\n11. Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with an investigational monoclonal antibody will be eligible to participate after a 150-day washout period.\n12. Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent that is not approved or is planning to participate in a study of a CMV vaccine or another unapproved CMV investigational agent during the course of this study.\n\n    \\-","75 Years",{"count":5,"type":21},[187],"This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient.\n\nThis study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.",[25,490,491,492],"Infection in Solid Organ Transplant Recipients","Neutropenia","Antiviral Toxicity",[494,238,495,496,497],"Cytomegalovirus infection","Secondary prophylaxis","T cell immunity","neutropenia","2025-04-07",{"date":500,"type":37},"2025-04-10",{"date":502,"type":37},"2023-02-02",{"date":504,"type":21},"2025-12-15",{"name":506,"class":44},"Tufts Medical Center",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":343,"enrollmentInfo":515,"targetDuration":4,"studyType":55,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":70},"100209752","phase-2-a-study-to-assess-safety-and-feasibility-of-direct-infusions-of-donor-derived-virus-specific-t-cells-in-recipients-of-hematopoietic-stem-cell-transplantation-with-post-transplant-viral-infections-using-the-cytokine-capture-system-100209752","NCT02007356","A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®","A Phase I\u002FII Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®","CCS","Inclusion Criteria:\n\n* Adults \\> 18 years of age\n* Undergone allogeneic HSCT\n* Written informed consent\n* Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:\n\nPatient with Adenovirus Infection:\n\n1. Antiviral treatment with cidofovir for at least 7 days\n\n   * no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or\n   * cluster of differentiation 3 (CD3) + cells \\\u003C 300\u002FµL on treatment for at least 7 days\n2. Or if antiviral treatment is contraindicated\n\nPatient with EBV:\n\n1\\. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg\u002Fm2)\n\n* No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or\n* CD3+ cells \\\u003C 300\u002FµL 7 days after receipt of treatment or\n* Clinical progression\n\nPatient with CMV:\n\n1. Antiviral treatment with ganciclovir or foscavir for 14 days\n\n   \\- No Virus load decrease (≤ 1 log) or virus load increase on day 14\n2. Or if \\> 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells \\\u003C 300\u002FµL\n3. Or if antiviral treatment is contraindicated -\n\nPatient Exclusion Criteria:\n\n* graft-versus-host disease (GVHD) \\> grade 2 at the time point of planned infusion\n* Known allergy to iron-dextran or murine antibodies",{"count":516,"type":21},30,[161],"To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).",[396,520,25,349,521],"EBV","Allogenic Disease","2025-03-19",{"date":524,"type":37},"2025-03-20",{"date":526,"type":37},"2014-12",{"date":528,"type":21},"2026-12",{"name":530,"class":44},"University Hospital, Basel, Switzerland",{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":17,"minAge":538,"maxAge":343,"enrollmentInfo":539,"targetDuration":4,"studyType":55,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":70},"100560078","phase-2-atg-individualized-dosing-model-in-urd-pbsct-100560078","NCT06572462","ATG Individualized Dosing Model in URD-PBSCT.","Application of Thymoglobulin (ATG) Individualized Dosing Model in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation.\n2. HLA-matched unrelated donor\n3. Patient age ≥14 years old and ≤65 years old\n4. ALT and AST ≤ 2.5 times the upper limit of normal values, bilirubin ≤ 2 times the upper limit of normal values\n5. Creatinine ≤ high limit of normal value\n6. No uncontrollable infection or serious mental illness\n7. Physical strength score is 0-2 (ECOG)\n8. Sign the informed consent form\n\nExclusion Criteria:\n\n1. Unrelated donor who is not HLA matched\n2. No indication for allogeneic hematopoietic stem cell transplantation\n3. Patient age \\\u003C14 years old or \\>65 years old\n4. The donor or recipient are pregnant\n5. Suffering from mental illness or other conditions and being unable to proceed as planned","14 Years",{"count":516,"type":21},[161],"Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation to prevent severe graft-versus-host disease (GVHD) and graft failure. However, overexposure to ATG may increase cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation, non-relapse mortality, and disease recurrence. A targeted dosing strategy was established based on ATG concentration monitoring and conducted a phase 2 trial to evaluate the safety and efficacy of the dosing strategy in adult unmanipulated haplo-PBSCT, a encouraging result was attained. In this trial, The ATG-targeted dosing strategy was extended to adult unrelated donor allogeneic hematopoietic stem cell transplantation, ATG was administered for 4 days (-5 days to -2 days) during conditioning. The ATG doses on-3 days and- 2days were adjusted by our dosing strategy to achieve the optimal ATG exposure. The primary endpoint was CMV reactivation on +180 days.",[25,543,544],"Infection Reactivation","Stem Cell Transplant Complications","2024-11-28",{"date":547,"type":37},"2024-12-03",{"date":549,"type":37},"2020-12-31",{"date":551,"type":21},"2025-06-30",{"name":553,"class":44},"Chinese PLA General Hospital",{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":55,"phases":564,"briefSummary":565,"conditions":566,"keywords":571,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":70},"100542336","quantiferon-cmv-to-identify-treatment-need-for-asymptomatic-cmv-infection-after-solid-organ-transplant-quantifot-100542336","NCT06341543","Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)","Use of QuantiFERON® CMV in the Therapeutic Decision in Asymptomatic CMV Infection in Solid Organ Transplant Recipients","QUANTIFOT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Solid organ transplant recipient (heart, kidney, liver and lung)\n* Detectable CMV viral load between 1,000 and 15,000 IU\u002FmL (including 2 borderline values):\n\n  * Asymptomatic (no fever or organ dysfunction) ;\n  * Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;\n  * Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.\n* Having signed an informed consent form.\n* Affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Presence of anti-Herpesviridae treatment when CMV replication is detected (\\[val\\]aciclovir, \\[val\\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).\n* Pregnant or breast-feeding women.\n* Persons under guardianship or trusteeship.\n* Subjects under administrative or judicial supervision.\n* Subject unable to be contacted in case of emergency.",{"count":563,"type":21},288,[234],"Context\n\nCytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.\n\nMost of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and\u002For disease, and who ill benefit the most from antiviral therapy.\n\nAs CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).\n\nAim of the study\n\nThe aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.\n\nMethods\n\nParticipation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU\u002FmL.\n\nThe QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).\n\n* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.\n* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.\n\nIn the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).\n\nThe participants will be sampled:\n\n* 5 to 12 days after QF-CMV sampling (V2) ;\n* 7 to 14 days days after V2 (V3 - between D12 and D26) ;\n* 7 to 14 days days after V3 (V4 - between D19 and D40) .\n\nEndpoints\n\nThe primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:\n\n* Blood CMV viral load \\>10,000 IU\u002FmL \\[4 log\\];\n* And\u002For increase in blood viral load ≥0.5 log IU\u002FmL with CV otherwise \\>5000 IU\u002FmL;\n* And\u002For the onset of CMV disease.\n\nThe secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).",[25,567,568,569,570],"Heart Transplantation","Kidney Transplantation","Lung Transplantation","Liver Transplantation",[572,573,166,574,575,576,577,578,579],"solid organ transplantation","cytomegalovirus","quantiferon","IGRA","interferon gamma release assay","antiviral","adverse effect","viremia","2024-09-27",{"date":582,"type":37},"2024-10-01",{"date":584,"type":37},"2024-09-24",{"date":586,"type":21},"2026-10",{"name":588,"class":44},"University Hospital, Grenoble",{"id":590,"slug":591,"hasResults":11,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":11,"sex":17,"minAge":596,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":606,"leadSponsor":608,"locationsCount":70},"100558674","evaluation-of-cmvebv-cmi-in-haploid-hsct-100558674","NCT06554197","Evaluation of CMV\u002FEBV-CMI in Haploid HSCT","Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. All patients were diagnosed with hemopathy.\n2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.\n3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.\n\nExclusion Criteria:\n\nPatients with any conditions not suitable for the trial (investigators' decision).","16 Years","60 Years",{"count":599,"type":21},60,"The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .",[191,25,84],"2024-08-13",{"date":604,"type":37},"2024-08-15",{"date":602,"type":21},{"date":607,"type":21},"2026-07-31",{"name":247,"class":44},{"id":610,"slug":611,"hasResults":11,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":11,"sex":17,"minAge":255,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":618,"conditions":619,"keywords":620,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":629,"locationsCount":70},"100556267","cytomegalovirus-cmv-transmission-and-immune-tracking-transmit-study-100556267","NCT06522880","Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study","Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study: An Observational Study to Evaluate CMV Transmission and Immune Correlates of Viral Shedding Among Young Children in Early Education and Care Settings","Inclusion Criteria\n\nChildren\n\n1. All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled.\n2. Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home\n\nCenter Staff\n\n1. Individuals who regularly (average \\>\u002F= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.\n2. Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home\n\nExclusion Criteria\n\nChildren\n\n1. \\>\u002F= 37 months of age\n2. State Department of Children and Families (DCF) custody\n\nCenter Staff\n\n1. Do not regularly (average \\\u003C 5 days per year) work inside the center\n2. Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)","36 Months",{"count":20,"type":21},"The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.",[25],[573,166,621,622],"congenital cytomegalovirus","cCMV","2024-07-25",{"date":625,"type":37},"2024-07-26",{"date":627,"type":37},"2023-08-10",{"date":381,"type":21},{"name":630,"class":44},"University of Massachusetts, Worcester",{"id":632,"slug":633,"hasResults":11,"nctId":634,"briefTitle":635,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":11,"sex":17,"minAge":638,"maxAge":639,"enrollmentInfo":640,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":150},"100520614","incidence-and-risks-factors-of-cmv-reactivation-in-patients-receiving-of-car-t-cells-for-acute-leukemia-and-lymphoma-relapse-a-cohort-study-analysis-100520614","NCT06058858","Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis","CMV CAR-T","Common inclusion criteria :\n\n* Paediatric (1 to 18 years old) receiving CART-T cells treatment for refractory acute leukemia or B-cell lymphoma\n* Adult receiving CART-T cells treatment for refractory acute leukemia or B-cell lymphoma\n* CMV seropositive patients\n\nInclusion criteria : retrospective part\n\n* Provide written non-opposition from the patient signed by investigator\n* If the patient is a minor, provide written non-opposition from both parents and child (if age appropriate to collect their non-objection) or child and the legal representative in case only one parent is alive, signed by investigator\n\nInclusion criteria : prospective part\n\n* Provide written consent form signed by patient and investigator\n* If the patient is a minor, provide written consent form signed by investigator and both parents or signed by investigator and the legal representative in case only one parent is alive\n\nExclusion Criteria:\n\n* CMV seronegative patients\n* Lack of affiliation to a social security scheme (as a beneficiary or assignee)\n* Patients under guardianship \u002F curatorship\n* Patient under AME (state medical aid)","1 Year","100 Years",{"count":641,"type":21},250,"Letermovir is approved for the primary prevention of Cytomegalovirus (CMV) reactivation and infection in hematopoietic stem cell transplant recipients. Letermovir may be beneficial in other clinical presentation where CMV reactivates and may alter clinical outcomes. Recently Chimeric Antigen Receptor (CAR) T cells have been used for the treatment of refractory acute leukemia and B cell lymphoma. Reactivation of chronic viral infections, in particular those belonging to the Herpesviridae family can therefore be observed following CAR-T cells treatment.According to first reports, Cytomegalovirus seems to be the main virus detected. Uncontrolled CMV reactivation leads to CMV disease requiring the use of antiviral drugs associated with either hematological toxicity (ganciclovir) or renal toxicity (foscarnet) and is usually associated with poor outcomes. In addition, CMV interplays with the immune system and decreases the immunosurveillance of tumor cells and facilitates the growth or reactivation of other opportunistic infections. Therefore, CMV reactivation could also impact the outcome of CART cells treatment by increasing the existing risk of opportunistic infections in CART cells recipients and thus by increasing morbidity, length stay or require intensive care. Imbalance of the immune system usually correlates with reactivation of persistent virus like Torquetenovirus (TTV), redondovirus or pegivirus found more frequently in Hematopoietic stem-cell transplantation (HSCT) patients or patients requiring intensive care. Whether reactivations of those persistent viruses are associated or precede CMV reactivation deserve careful investigation to identify as early as possible patients at high risk and who could benefit from antiviral preventive treatment.\n\nThe objective of this trial is to determine the incidence of CMV reactivation within 3 months after infusion of CAR-T cells in CMV seropositive patients with refractory acute leukemia or B-cell lymphoma.",[25,644,645],"Acute Leukemia","B Cell Lymphoma","2024-07-15",{"date":648,"type":37},"2024-07-17",{"date":650,"type":37},"2024-04-17",{"date":652,"type":21},"2025-04-17",{"name":149,"class":44}]