[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-leukaemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"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":21,"type":22},51,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Acute Myeloid Leukaemia (AML)","Acute Lymphoblastic Leukemia ALL","High Risk Leukaemia","Leukaemia Relapse",[33,17,15,34,35,36,37],"AML","Total marrow\u002Flymphoid irradiation","Treg","Tcon","Relapse","RECRUITING","2025-03-01",{"date":41,"type":42},"2025-03-04","ACTUAL",{"date":44,"type":42},"2025-02-25",{"date":46,"type":22},"2031-01",{"name":48,"class":49},"University Of Perugia","OTHER"]