[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581075":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":32,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Of Perugia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TMLI based contioning and Treg\u002FTcon adoptive immunotherapy in allogeneic cell transplantation","EXPERIMENTAL","All enrolled patients will receive a 20Gy-TMLI based conditioning regimen followed by the infusion of donor graft and Treg\u002FTcon adoptive immunotherapy",[13],"Radiation: total marrow\u002Flymphoid irradiation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","total marrow\u002Flymphoid irradiation","Combination of 20 Gy TMLI with Treg\u002FTcon adoptive immunotherapy in allogeneic cell transplantation",[9],null,[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Antonio Pierini","CONTACT","+393355477611","+39","antonio.pierini@unipg.it",{"name":29,"role":24,"phone":30,"phoneExt":26,"email":31},"Loredana Ruggeri","+393388953982","loredana.ruggeri@ospedale.perugia.it",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Università degli Studi di Perugia","RECRUITING","Perugia","PG","06100","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],12.38878,43.1122,{"lat":45,"lon":44},[48],{"name":49,"role":24,"phone":50,"phoneExt":20,"email":27},"Antonio Pierini, MD, PhD","3355477611",{"type":52,"investigatorFullName":23,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100581075","safely-delivered-targeted-high-dose-irradiation-followed-by-adoptive-immunotherapy-with-regulatory-and-conventional-t-cells-to-increase-potency-of-hematopoietic-stem-cell-transplantation-in-high-risk-acute-leukemia-100581075",false,"NCT06845592","Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia","SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia","SHARP","Inclusion Criteria:\n\n* AML patients\n\n  * Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.\n  * Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.\n  * Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg\u002Fkg\u002Fdie) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n  * Age ≥ 18 and ≤ 65 years\n  * ECOG ≤ 2\n  * HCT-CI ≤ 4 (51,52)\n  * Absence of relevant psychiatric diseases\n  * Signature of the informed consent\n\nALL patients\n\n* Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant\n* Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.\n* Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg\u002Fkg\u002Fdie) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n* Age ≥ 18 and ≤ 65 years\n* ECOG ≤ 2\n* HCT-CI ≤ 4\n* Absence of relevant psychiatric diseases\n* Signature of the informed consent\n\nExclusion Criteria:\n\n* AML patients\n\n  * AML in CR MRD-\n  * AML with \\> 5% peripheral blasts or bone marrow infiltration ≥ 30%\n  * Age \\\u003C 18 years or \\> 65 years\n  * ECOG \\> 2\n  * Unacceptable lung, liver, kidney, and\u002For heart function and presence of relevant psychiatric diseases according to clinical judgment\n  * Pregnancy\n  * No signature of the informed consent\n* ALL patients\n\n  * ALL with \\> 5% peripheral blasts or bone marrow infiltration ≥30%\n  * Philadelphia positive ALL\n  * Age \\\u003C 18 years or \\> 65 years\n  * ECOG \\> 2\n  * Unacceptable lung, liver, kidney, and\u002For heart function and presence of relevant psychiatric diseases according to clinical judgment\n  * Pregnancy\n  * No signature of the informed consent","ALL","18 Years","65 Years",{"count":66,"type":67},51,"ESTIMATED","INTERVENTIONAL",[70],"NA","The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg\u002FTcon adoptive immunotherapy for high-risk acute leukemia patients.",[73,74,75,76],"Acute Myeloid Leukaemia (AML)","Acute Lymphoblastic Leukemia ALL","High Risk Leukaemia","Leukaemia Relapse",[78,62,60,79,80,81,82],"AML","Total marrow\u002Flymphoid irradiation","Treg","Tcon","Relapse","2025-03-01",{"date":85,"type":86},"2025-03-04","ACTUAL",{"date":88,"type":86},"2025-02-25",{"date":90,"type":67},"2031-01",{"name":5,"class":6},1]