[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626873":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T group","EXPERIMENTAL","Autologous CD19 CAR-T (1.0×10⁶\u002Fkg, single IV infusion) after cyclophosphamide + fludarabine lymphodepletion (no bridging chemo).",[13],"Biological: CAR-T",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Chemotherapy + DLI",[19],"Biological: DLI",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","CAR-T","Autologous CD19 CAR-T cells (1.0×10⁶\u002Fkg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg\u002Fm²\u002Fd ×3d) + fludarabine (30mg\u002Fm²\u002Fd ×3d); no bridging chemotherapy allowed.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"DLI","Chemotherapy combined with DLI",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Jing Liu, Doctor","CONTACT","8610-88326900","greenimp@163.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":41,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Beijing","China","100044","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":35,"phoneExt":26,"email":36},"Jing Liu",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Xiao-Jun Huang","Chief","100626873","phase-3-cd19-car-t-vs-dli-for-post-hsct-mrd-in-ph--all-a-rct-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":68,"type":69},70,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75,76,77],"B ALL","Allogenetic Hematopoietic Stem Cell Transplantation","MRD-positive",[79,80,81,82,83],"CD19 CAR-T","Donor Lymphocyte Infusion (DLI)","Ph-negative B-ALL","Minimal Residual Disease (MRD)","Hematopoietic Stem Cell Transplantation (HSCT)","2026-02-24",{"date":86,"type":87},"2026-02-27","ACTUAL",{"date":89,"type":87},"2025-11-30",{"date":91,"type":69},"2028-12-30",{"name":5,"class":6},1]