[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574073":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":34,"collaborators":20,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":20,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":20,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":20},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont","EXPERIMENTAL","One arm,Azacitidine is administered subcutaneously at 32 mg\u002Fm2\u002Fd for five consecutive days, starting no earlier than day +90 after HSCT, then repeated every 28 days for a total of twelve cycles. DLI is administered after an interval of 48 hours. Prophylactic DLI is given in escalating doses every four to six weeks for a total of three to four doses.The initial dose of DLI for haploid transplant patients is 1×10\\^5 CD3+\u002Fkg receptor weight lymphocytes gradually increased to 5×10\\^5, 1×10\\^6 and (2\\~5)×10\\^6 CD3+ Lymphocytes",[13],"Drug: Azacitidine (AZA)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Azacitidine (AZA)","Azacitidine 32mg\u002Fm2",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Xianmin Song, M.D","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","021-63240090","shongxm@139.com",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Ying zhang, doctor","021-37798987","zhangyingm03@163.com",{"type":24,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Xianmin Song, MD","director","100574073","phase-2-azacitidine-combined-with-donor-lymphocyte-infusion-for-acute-myeloid-leukemia-post-transplant-relapse-prevention-100574073",false,"NCT06754540","Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.","Efficacy and Safety of Azacitidine Combined with Donor Lymphocyte Infusion for Prevention of Recurrence After Haploid Hematopoietic Stem Cell Transplantation in High-risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n\\-\n\nPatients enrolled must meet the following criteria:\n\n1. ≥18 years old and ≤70 years old, male or female;\n2. Patients with haploid peripheral blood stem cell transplantation of AML;\n3. All patients received BU based myeloablative conditionings;\n4. A diagnosis of high-risk AML is one of the following:\n\n   ① Patients without morphologic CR before transplantation, including patients with initial refractory disease and recurrence.\n\n   ② AML with poor prognosis (Standardized diagnosis and prognostic stratification of acute myeloid leukemia based on ELN edition which was 2022 Year) .\n5. Blood routine: neutrophils ≥1×10\\^9\u002FL, platelet ≥50.0×10\\^9\u002FL;\n6. There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;\n7. The ECOG score is 0 to 2;\n8. Donor lymphocytes are available;\n9. The patient must be able to understand and be willing to participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Possible subjects who meet any of the following criteria will be excluded from the trial:\n\n  1. Those who are allergic to known azacitidine or interferon\n  2. Patients with active acute GVHD;\n  3. Patients with moderate or more chronic GVHD;\n  4. Non-haploid donor transplants;\n  5. Patients who have not achieved complete remission after transplantation;\n  6. AML recurrence after transplantation (bone marrow, peripheral blood primitive cells ≥5% or extramedullary recurrence), or graft rejection, bone marrow donor cell chimeric rate (STR) \\\u003C90%;\n  7. Patient blood routine: ANC\\\u003C1.0×10\\^9\u002FL or PLT\\\u003C50×10\\^9\u002FL;\n  8. Combined with severe organ dysfunction:liver function (AST\u002FALT) \\>3 times normal upper limit; the direct bilirubin \\> 3 times normal upper limit; renal function (Cr) \\\u003C 50mL\u002Fmin or \\>1.5 times normal upper limit, regardless of hemodialysis treatment;\n  9. Patient with severe active infection;\n  10. Pregnant or lactating women;\n  11. Have received other interventions or are receiving other research drugs before the study begins;\n  12. At the discretion of the investigator, other dangerous complications may result.","ALL","18 Years","70 Years",{"count":48,"type":49},51,"ESTIMATED","INTERVENTIONAL",[52],"PHASE2","This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.\n\nAt the screening\u002Fbaseline period, informed consent is obtained and the inclusion\u002Fexclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.",[55,56],"Acute Myeloid Leukemia (AML)","Relapse",[58,59,60,61,62,63],"azacitidine","donor lymphocyte infusion","HSCT","haploid","high-risk","AML","NOT_YET_RECRUITING","2025-01-14",{"date":67,"type":68},"2025-01-17","ACTUAL",{"date":70,"type":49},"2025-01-16",{"date":72,"type":49},"2027-01-01",{"name":5,"class":6}]