[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allogenetic-hematopoietic-stem-cell-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allogenetic-hematopoietic-stem-cell-transplantation":47},{"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":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100626873",false,"NCT07441291","CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT","CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* age 3-\\\u003C80 years\n* ECOG performance status 0-2\n* post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)\n* no hematological\u002Fextramedullary relapse\n* adequate organ function\n* negative pregnancy test (for fertile females)\n\nExclusion Criteria:\n\n* active infections\n* uncontrolled graft-versus-host disease (GVHD)\n* history of central nervous system disorders\n* autoimmune diseases\n* other active malignancies","ALL","3 Years","79 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT).\n\nPatients (aged 3-\\\u003C80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI.\n\nThe primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity.\n\nThe study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.",[26,27,28],"B ALL","Allogenetic Hematopoietic Stem Cell Transplantation","MRD-positive",[30,31,32,33,34],"CD19 CAR-T","Donor Lymphocyte Infusion (DLI)","Ph-negative B-ALL","Minimal Residual Disease (MRD)","Hematopoietic Stem Cell Transplantation (HSCT)","RECRUITING","2026-02-24",{"date":38,"type":39},"2026-02-27","ACTUAL",{"date":41,"type":39},"2025-11-30",{"date":43,"type":20},"2028-12-30",{"name":45,"class":46},"Peking University People's Hospital","OTHER",""]