[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-b-acute-lymphoblastic-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-b-acute-lymphoblastic-leukaemia":41},{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100357706",false,"NCT03937544","Intravenous Autologous CD19 CAR-T Cells for R\u002FR B-ALL","A Phase II\u002FIII Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed\u002F Refractory B-Acute Lymphoblastic Leukaemia","Inclusion Criteria:\n\n* Patients with relapsed\u002Frefractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics\n* Age between ≥13 to ≤ 65 years\n* No detectable leukaemia in the CSF (CNS-1)\n* CNS leukaemia without clinically evident neurological symptoms (CNS-2; with \\\u003C5 WBC per μL and cytology positive for blasts)\n* Adequate organ function as defined by a creatinine clearance \\> 50 ml\u002Fmin, serum total bilirubin \\\u003C 5 times the normal value, left ventricular ejection fraction \\> 40%\n* ECOG performance status ≤ 2\n* Life expectancy \\> 3 months\n* Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression\n* Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods\n* Male patients must use highly effective contraception methods\n\nExclusion Criteria:\n\n* Patients with CNS-3 leukaemia.\n* Active cancer (other than B-ALL).\n* Evidence of severe lung, heart (NYHA class III\u002FIV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.\n* Presence of active autoimmune disease or atopic allergy.\n* HIV serology positivity.\n* Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.\n* Uncontrolled sepsis\n* Pregnant \u002F nursing female.\n* Ongoing prednisolone \\> 1mg\u002Fkg daily or equivalent.\n* Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.","ALL","13 Years","65 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is Phase II \u002F III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed \u002F Refractory B-Acute Lymphoblastic Leukaemia",[27,28],"Relapsed B Acute Lymphoblastic Leukaemia","Refractory B Acute Lymphoblastic Leukaemia","RECRUITING","2025-05-22",{"date":32,"type":33},"2025-05-29","ACTUAL",{"date":35,"type":33},"2019-03-19",{"date":37,"type":20},"2027-03-18",{"name":39,"class":40},"National University of Malaysia","OTHER",""]