[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transplant-related-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transplant-related-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,67,96,114,135,191,217,239],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100521235","phase-2-open-label-trial-of-oral-letermovir-for-cmv-prophylaxis-in-thoracic-transplant-recipients-100521235",false,"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.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27],"Cytomegalovirus Infections","Transplant-Related Disorder",[29,30],"CMV","Thoracic Transplant","RECRUITING","2026-06-01",{"date":34,"type":35},"2026-06-03","ACTUAL",{"date":37,"type":35},"2024-04-04",{"date":39,"type":20},"2026-08-15",{"name":41,"class":42},"University of Pennsylvania","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100640689","phase-3-dagoat-guided-prevention-of-severe-agvhd-after-allo-hsct-100640689","NCT07588945","daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT","A Multicenter Randomized Controlled Trial of daGOAT Model-guided Prevention of Severe Acute Graft-versus-host Disease in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Age \\> 16 years old.\n2. HLA-haploidentical transplant.\n3. Able to take oral medications.\n4. Patients must provide written informed consent before the start of the study procedures.\n\nExclusion Criteria:\n\n1. Patients who have undergone tandem transplantation or multiple transplantations.\n2. Patients who are allergic to or cannot tolerate ruxolitinib.\n3. Patients with mental or other medical conditions that make them unable to comply with the study treatment and monitoring requirements.\n4. Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.","16 Years",{"count":53,"type":20},438,[55],"PHASE3","This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.",[27],"NOT_YET_RECRUITING","2026-05-10",{"date":61,"type":35},"2026-05-15",{"date":32,"type":20},{"date":64,"type":20},"2028-06-01",{"name":66,"class":42},"Institute of Hematology & Blood Diseases Hospital, China",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":43},"100589159","changes-in-glucose-tolerance-in-patients-with-cirrhosis-peri-liver-transplant-100589159","NCT06950788","Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant","Inclusion Criteria:\n\n* Patients presenting to liver transplant clinic with a diagnosis of cirrhosis.\n* Age \\>18 yrs.\n* Ability to understand and sign written consent form, or have a legally-authorized representative or proxy who can be approached for consent\n\nExclusion Criteria:\n\n* Patients without consent\n* Patients with implantable cardioverter defibrillator devices or automated implantable cardioverter defibrillator devices will be excluded from the bio-electrical impedance analysis portion of the measurements.\n* Patients with unremovable electrical medical devices or devices that cannot turn off will be excluded from the bio-electrical impedance analysis measurements\n* Pregnant patients\n* Incarcerated patients\n* Patients with a history of type 2 diabetes mellitus diagnosed \\> 5 years ago will be excluded from the Oral Glucose Tolerance Test portion of the study","75 Years",{"count":75,"type":20},60,"OBSERVATIONAL","The goal of this observational study is to establish risk factors for post-transplant in adult individuals with cirrhosis without diabetes undergoing liver transplant evaluation.\n\nThe question being addressed is: can laboratory work, anthropometric tests, functional tests, imaging, and advanced measurements such as wrist actigraphy, continuous glucose monitoring, or oral glucose tolerance testing predict the development of diabetes after liver transplant?\n\nParticipants will be asked to periodically participate in wearing a continuous glucose monitor and wrist actigraph and obtain an oral glucose tolerance test both before and after liver transplant.",[79,80,81,27],"Cirrhosis, Liver","Diabetes Mellitus Risk","Transplant; Failure, Liver",[83,84,85,86],"Cirrhosis","Post-transplant diabetes","New-onset diabetes after transplant","Liver transplantation","2026-05-01",{"date":89,"type":35},"2026-05-07",{"date":91,"type":35},"2024-03-12",{"date":93,"type":20},"2031-01",{"name":95,"class":42},"University of Chicago",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":43},"100621765","a-cohort-study-on-the-association-between-the-ans-function-and-acute-gvhd-100621765","NCT07374874","A Cohort Study on the Association Between the ANS Function and Acute GvHD","A Cohort Study on the Association Between the Autonomic Nervous System Function and Acute GvHD After Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients must be \\> 16 years of age;\n2. Patients receiving HLA-haploidentical transplants;\n3. Patients have to sign an informed consent form before the start of the research procedure.\n\nExclusion Criteria:\n\n1. Tandem transplantation or multiple transplantations;\n2. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;\n3. Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.",{"count":75,"type":20},"This is a prospective observational study. The investigators plan to utilize this model as a tool for early classification and interrogate ANS function of transplant recipients.",[27],"2026-01-23",{"date":108,"type":35},"2026-01-29",{"date":110,"type":35},"2025-12-18",{"date":112,"type":20},"2027-01-01",{"name":66,"class":42},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":121,"enrollmentInfo":4,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":133,"locationsCount":43},"100546340","treatment-use-of-the-clinimacs-cd34-tcr-alphabeta-for-allogenic-transplant-expanded-access-use-100546340","NCT06393660","Treatment Use of the CliniMACS® CD34 TCR Alpha\u002FBeta for Allogenic Transplant (Expanded Access Use)","Treatment Use of the CliniMACS® CD34 TCR Alpha\u002FBeta to Prepare Cells for an Unlabeled Indication Using an HLA-Compatible Related or Unrelated Donor for Allogenic Transplant","Recipient Inclusion Criteria:\n\n* Age less than 22 years of age\n* No available genotypically matched related donor (sibling)\n* Availability of a suitable donor and graft source\n* Haploidentical related mobilized peripheral blood cells\n* 9\u002F10 or 10\u002F10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells\n\nDonor Inclusion Criteria:\n\n* Matching as described in the Recipient and Donor Suitability Criteria\n* Size and vascular access appropriate by center standard for peripheral blood stem cell (PBSC) collection. Donors with inadequate peripheral access will require placement of an apheresis catheter for collection.\n* Must meet appropriate screening\u002Feligibility requirements:\n\n  * Haploidentical matched family members: screened by center health screens and found to be eligible.\n  * Unrelated donors: meet suitability criteria to donate PBSC\n  * HIV negative\n  * Not pregnant or lactating\n  * Recipient must not have high-level donor specific anti-HLA antibodies according to institutional practices.\n  * Must agree to donate PBSC\n  * Must give informed consent\n\nRecipient Suitability:\n\n\\- Adequate organ functioning as demonstrated by:\n\n* MUGA ≥ 50% or ECHO \\>30%\n* 24-hour Creatinine Clearance or Glofil ≥ 50 ml\u002Fmin or Serum Creatinine ≤2 times the upper limit of normal\n* DLCO \\> 65% of predicted value. FEV1 \\>65% of predicted\n* AST \u002F ALT ≤ 2.5 and\u002For Bilirubin ≤ 1.5 times the upper limit of normal\n* Pregnancy test negative\n* HIV 1 \u002F 2 (HIV screen) negative with a negative qualitative HIV PCR.\n* HTLV I negative\n* RPR or VDRL negative\n* RVP (Respiratory Viral PCR) with a negative result\n* Positive hepatitis testing does not make the patient ineligible. Hepatitis results will be evaluated on a case-by-case basis by the transplant physician to determine donor suitability\u002Feligibility.\n\nDonor Suitability:\n\n\\- Allowed Donor Sources\n\n* Fully matched sibling donors are not allowed.\n* Unrelated donors. HLA typing of at least 10 alleles is required. Donor must be matched at 9\u002F10 or 10\u002F10 alleles (HLA-A, -B, -C, -DRB1, -DQB1). Haploidentical matched family members. Minimum match level full haploidentical (at least 5\u002F10; HLA-A, -B, -C, -DRB1, -DQB1 alleles), but use of haploidentical donors with extra matches (e.g., 6, 7, or 8\u002F10) encouraged.\n* Cord blood is not allowed as a stem cell source on this IDE.\n\nRecipient and Donor Exclusion Criteria:\n\n* Pregnant or lactating females are ineligible as the risk to unborn children and infants is unknown\n* Presence of life-threatening, uncontrolled opportunistic infection (fungal, bacterial, or viral infections). Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation.\n* HIV or HTLV I\u002FII infection","21 Years","EXPANDED_ACCESS","The protocol is designed to provide access to patients to the Clinimacs® CD34 TCRαβ system to prepare cells for an unlabeled indication using an HLA-compatible related or unrelated donor for allogenic transplant.",[27,125],"GVH - Graft Versus Host Reaction",[127,128],"TCR Alpha\u002FBeta","CliniMACS","AVAILABLE","2025-10-11",{"date":132,"type":35},"2025-10-14",{"name":134,"class":42},"Victor Aquino",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":157,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100605053","phase-2-radioimmunotherapy-conditioning-with-131i--apamistamab-for-allogeneic-transplant-in-relapserefractory-aml-100605053","NCT07157514","Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse\u002FRefractory AML","An Adaptive, Operationally Seamless Phase II \u002F III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease","Inclusion Criteria:\n\n1. Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.\n2. 2R\u002FR AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission \\\u003C6 months, relapse refractory to salvage combination therapy or second or subsequent relapse\n3. Documented CD45 expression by leukemic cells via flow cytometry.\n4. ≥18 years of age and not suitable for myeloablative conditioning regimen.\n5. Circulating blast count \\\u003C10,000\u002Fmm³ (hydroxyurea allowed).\n6. Calculated creatinine clearance (Cockcroft-Gault) \\>50 mL\u002Fmin.\n7. Adequate hepatic function: AST\u002FALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's).\n8. Karnofsky performance score ≥70.\n9. Expected survival \\>60 days.\n10. Central venous catheter line in place before study treatment.\n11. 8\u002F8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1).\n12. Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant.\n13. Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose.\n14. Able to understand procedures, provide informed consent, and comply with study requirements.\n\nExclusion Criteria:\n\n1. Positive human anti-mouse antibody (HAMA) at screening.\n2. \\>20% leukemic blasts in marrow.\n3. Prior radiation to maximally tolerated levels of any critical organ.\n4. Active CNS leukemia (blasts in CSF or CNS chloromas).\n5. Prior allogeneic or autologous HSCT.\n6. Candidates suitable for myeloablative conditioning.\n7. Clinically significant cardiac disease, including: NYHA Class III or IV heart failure, Clinically significant arrhythmias (ventricular tachycardia, ventricular fibrillation, Torsade de Pointes), Myocardial infarction with uncontrolled angina within 6 months, Clinically significant congestive heart failure or cardiomyopathy\n8. QTcF \\>450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional).\n9. Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function).\n10. Active, uncontrolled infection.\n11. Acute promyelocytic leukemia (t\\[15;17\\]).\n12. Active malignancy within 2 years, except: Myelodysplastic syndrome, Treated non-melanoma skin cancer, Completely resected stage 0-1 melanoma (\\>1 year from resection), Carcinoma in situ or cervical intraepithelial neoplasia, Organ-confined prostate cancer without progression\n13. Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation.\n14. Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).",{"count":143,"type":20},306,[23,55],"This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.",[147,148,149,150,151,152,153,154,27,155,156],"Acute Leukemia","Myeloid Leukemia","Acute Myelogenous Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse","Myelogenous Leukemia","Myelogenous Leukemia, Acute","Myelogenous Leukemia in Relapse","Allogeneic Disease","Refractory AML",[150,158,159,160,161,162,156,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180],"Leukemia","Acute Myeloid","Acute Bone Marrow Cell Transplant","Transplant","Bone Marrow HCT","Relapsed AML","I-131","Iomab","I131- Apamistamab","Iodine","Iodine-131","131-I AML","Iomab-B","Radioimmunotherapy","Allogeneic Transplant","Radiotherapy","CD45","Anti-CD45 antibody","Apamistamab","Fludarabine","Bone Marrow Transplant","Radiolabeled antibody therapy","131I -apamistamab","2025-09-04",{"date":183,"type":35},"2025-09-10",{"date":185,"type":20},"2026-01",{"date":187,"type":20},"2034-02",{"name":189,"class":190},"Actinium Pharmaceuticals","INDUSTRY",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":198,"maxAge":17,"enrollmentInfo":199,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":43},"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","1 Month",{"count":200,"type":20},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.",[203,26,204,27],"Immunoglobulin Prophylaxis","Allogeneic Hematopoietic Stem Cell Transplantation",[206,207,208],"Cytomegalovirus","allo-HSCT","Transplant-Related mortality","2025-06-02",{"date":211,"type":35},"2025-06-10",{"date":209,"type":35},{"date":214,"type":20},"2026-06-02",{"name":216,"class":42},"Antonello Di Paolo, M.D., Ph.D.",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":43},"100584372","phase-3-optimal-timing-of-hepatitis-b-vaccination-after-transplants-100584372","NCT06888479","Optimal Timing of Hepatitis B Vaccination After Transplants","Optimal Timing of Hepatitis B Vaccination After Transplants: a Randomized Clinical Study","Inclusion Criteria:\n\n1. Patients must be ≥ 16 years old;\n2. Patients receiving hematopoietic cell transplantation;\n3. Patients achieving complete molecular remission;\n4. Patients or their guardians have to sign an informed consent form before the start of the research procedure.\n\nExclusion Criteria:\n\n1. Multiple transplantations;\n2. Donors' HBV-DNA or HBsAg are positive;\n3. Patients' HBV-DNA or HBsAg are positive before transplantation or \\\u003C 3 months after transplantation;\n4. Patients who are unable to comply with the research treatments and monitoring requirements due to mental or other medical conditions;\n5. Patients who are ineligible for the study due to other reasons which would cause unacceptable risks to the patients.",{"count":225,"type":20},1500,[55],"The investigators aim to perform a randomized clinical trial to determine the optimal timing of hepatitis B vaccination after hematopoietic cell transplantation (HCT) through evaluating the immunity effect of two different vaccination schedules (initiated at 3 or 6 months after transplantation) in patients with different immune reconstitution status.",[27,229,230],"Hepatitis B Virus Infection","Vaccine Reaction","2025-03-20",{"date":233,"type":35},"2025-03-21",{"date":235,"type":20},"2025-06-01",{"date":237,"type":20},"2029-03-01",{"name":66,"class":42},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":43},"100532079","using-the-composite-immune-risk-score-to-assess-and-modulate-the-patients-post-transplant-immune-reconstitution-100532079","NCT06208137","Using the Composite Immune Risk Score to Assess and Modulate the Patient's Post-transplant Immune Reconstitution.","Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.","Inclusion Criteria:\n\n* 1\\) Patients must be ≥ 16 years of age;\n* 2\\) Patients receiving haploidentical allo-HSCT;\n* 3\\) Patients have to sign an informed consent form before the start of the research procedure.\n\nExclusion Criteria:\n\n* 1\\) Tandem transplantation or multiple transplantations;\n* 2\\) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;\n* 3\\) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.",{"count":247,"type":20},456,[249],"NA","To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.",[27],"2024-08-11",{"date":254,"type":35},"2024-08-13",{"date":256,"type":35},"2024-02-29",{"date":258,"type":20},"2028-04-01",{"name":66,"class":42}]