[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366843":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":49,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Instituto de Investigación Marqués de Valdecilla","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CMV CTLs","EXPERIMENTAL","1x10\\^5 CMV-CTLs\u002Fkg",[13],"Biological: CMV CTLs",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Galo Peralta Fernandez, MD","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Miriam Sanchez-Escamilla, MD","CONTACT","+34646393234","msanchez@idival.org",{"name":31,"role":27,"phone":19,"phoneExt":19,"email":32},"Lucía Lavín Alconero, Phd","eclinicos5@idival.org",[34],{"facility":35,"status":36,"city":37,"state":19,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hospital Marques de Valdecilla","RECRUITING","Santander","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],-3.80493,43.46589,{"lat":44,"lon":43},[47],{"name":48,"role":27,"phone":19,"phoneExt":19,"email":19},"enrique ocio",{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100366843","phase-2-prophylaxis-of-cytomegalovirus-infection-with-adoptive-cell-inmunotherapy-100366843",false,"NCT04056533","Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy","Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy","INMUNOCELL","Inclusion Criteria:\n\n* Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).\n* Any source of stem cells (peripheral blood or bone marrow).\n* CMV-seropositive donors.\n* Negative pregnancy test in women.\n* Signed writen informed consent.\n* DONORS:\n\n  1. HLA haploidentical and CMV-seropositve donors.\n  2. Donor must be checked and suitable.\n  3. Signed writen informed consent.\n  4. Donor without active infection evidence at leukapheresis.\n\nExclusion Criteria:\n\n* Patients without haploidentical CMV-seropositive donors.\n* Patients who are not suitable for follow up visits.\n\nCMV-CTLs Infusion Criteria:\n\n* Hematopoiesis recovery at least partial (neutrophil counts \\>0.5x10\\^9\u002FL in at least 3 consecutive samples post-transplant).\n\nCMV-CTLs NON-Infusion Criteria:\n\n* Patients receiving corticosteroid (dose of 0.5mg\u002Fkg\u002Fday of prednisone or equivalent) at infusion.\n* ECOG \\> or = 3.\n* Organic toxicities grade \\> or = 3.\n* Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.\n* Patients with uncontroled infection defined by fevers and\u002For inestability and\u002For infection not resolved.\n* Persistent fevers 3 days before infusion.\n* Acute Graft Versus Host Disease (GVHD) grade II-IV.\n* Relapse or progression after transplant and before infusion day.\n* CMV reactivation\u002Finfection after transplant and before infusion day.\n\nPatients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.","ALL","18 Years","80 Years",{"count":63,"type":64},15,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.",[70],"CMV",[72,73,74],"Citomegalovirus","Haploidentical","Hematopoietic Stem Cell Transplantation","2024-08-27",{"date":77,"type":78},"2024-08-28","ACTUAL",{"date":80,"type":78},"2022-03-26",{"date":82,"type":64},"2026-12-01",{"name":5,"class":6},1]