[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636977":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":26,"locations":10,"responsibleParty":32,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":10,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":47,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":10,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Salvage Haploidentical HSCT Cohort",null,"Patients with relapsed\u002Frefractory acute myeloid leukemia (R\u002FR AML) who have active disease (bone marrow blasts \\>5% or extramedullary involvement) before transplantation, aged 18-65 years, and HCT-CI score ≤5. All patients in this single-arm prospective observational cohort will receive salvage haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) followed by standardized post-transplant relapse prevention strategies. Participants will be followed for 24 months after transplantation.",[13,14],"Procedure: Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (haplo-HSCT)","Drug: Post-transplant Maintenance Therapy",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"PROCEDURE","Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (haplo-HSCT)","Salvage haploidentical allogeneic hematopoietic stem cell transplantation using a conditioning regimen of Fludarabine (120-180 mg\u002Fm²), Busulfan (3-4 mg\u002Fkg), and MECCNU 250 mg\u002Fm² (intensity adjusted based on prognostic index). Targeted agents (sorafenib, midostaurin, or venetoclax) are added according to genetic mutations (e.g., FLT3) until stem cell infusion. GVHD prophylaxis includes ATG 6 mg\u002Fkg, tacrolimus (FK506), mycophenolate mofetil (MMF), and basiliximab on day +4. No MTX or post-transplant cyclophosphamide (PTCY) is used. Immunosuppressants are tapered within 100 days if no significant GVHD.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DRUG","Post-transplant Maintenance Therapy","Starting from approximately day +30 after transplantation, patients receive mutation-guided targeted therapy (sorafenib 200 mg daily for FLT3\u002FITD mutation) or azacitidine 75 mg\u002Fm² on days 1-3. Maintenance therapy aims to reduce the risk of relapse.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"wei MD, PhD","CONTACT","+86 027-85726003","shiwei076@hust.edu.cn",{"type":33,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636977","salvage-haploidentical-hsct-with-dli-and-targeted-therapy-for-rr-aml-100636977",false,"NCT07572695","Salvage Haploidentical HSCT With DLI and Targeted Therapy for R\u002FR AML","Salvage Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation Combined With Post-transplant Relapse Prevention Strategies for Relapsed\u002FRefractory Acute Myeloid Leukemia (AML): A Prospective Observational Study","Inclusion Criteria:\n\n* Signed and dated informed consent Willing and able to comply with all study procedures and follow-up Adults aged 18 to 65 years Diagnosis of acute myeloid leukemia (AML) Active disease before transplantation, defined as bone marrow blasts \\>5% or presence of extramedullary disease HCT-CI (Hematopoietic Cell Transplantation-Comorbidity Index) score ≤5\n\nExclusion Criteria:\n\n* Bone marrow blasts ≤5% without extramedullary disease before transplantation Age \\\u003C18 years or \\>65 years HCT-CI score \\>5 Patients with other diagnoses besides AML","ALL","18 Years","65 Years",{"count":45,"type":46},40,"ESTIMATED","24 Months","OBSERVATIONAL","This is a prospective, single-center, observational study to evaluate the efficacy and safety of salvage haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) combined with post-transplant relapse prevention strategies in patients with relapsed\u002Frefractory acute myeloid leukemia (R\u002FR AML).\n\nEligible patients are adults aged 18-65 years with active AML (bone marrow blasts \\>5% or extramedullary disease) and HCT-CI score ≤5. All patients will receive a uniform conditioning regimen consisting of fludarabine, busulfan, and MECCNU, with addition of targeted agents (such as sorafenib, midostaurin, or venetoclax) according to mutation status. Graft-versus-host disease (GVHD) prophylaxis includes reduced-dose ATG (6 mg\u002Fkg), FK506, MMF, and basiliximab. Post-transplant maintenance with targeted therapy or azacitidine and prophylactic donor lymphocyte infusion (DLI) will be administered to reduce relapse risk.\n\nThe primary endpoints are cumulative incidence of relapse (CIR), overall survival (OS), and progression-free survival (PFS). Secondary endpoints include incidence of acute and chronic GVHD, CMV\u002FEBV reactivation, non-relapse mortality (NRM), and GVHD-free, relapse-free survival. Patients will be followed for 24 months after transplantation. This study aims to explore an optimized transplant strategy to improve long-term survival in this high-risk population.",[51,52,53],"Acute Myeloid Leukemia","Relapsed\u002FRefractory Acute Myeloid Leukemia","AML, Relapsed\u002FRefractory","NOT_YET_RECRUITING","2026-05-03",{"date":57,"type":58},"2026-05-07","ACTUAL",{"date":60,"type":46},"2026-04-30",{"date":62,"type":46},"2028-12",{"name":5,"class":6}]