[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-b-acute-lymphoblastic-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-b-acute-lymphoblastic-leukaemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100357706","phase-2-intravenous-autologous-cd19-car-t-cells-for-rr-b-all-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":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24,25],"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",[28,29],"Relapsed B Acute Lymphoblastic Leukaemia","Refractory B Acute Lymphoblastic Leukaemia","RECRUITING","2025-05-22",{"date":33,"type":34},"2025-05-29","ACTUAL",{"date":36,"type":34},"2019-03-19",{"date":38,"type":21},"2027-03-18",{"name":40,"class":41},"National University of Malaysia","OTHER"]