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