[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357706":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":21,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":21,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":21,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"National University of Malaysia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19 CAR-T CELLS","EXPERIMENTAL","A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.",[13,14,15],"Biological: CD19 CAR-T CELLS","Drug: Cyclophosphamide","Drug: Fludarabine",[17,22,27],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Cyclophosphamide","Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg\u002Fm2\u002Fday IV(Day -5, Day -4, Day -3 ).",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":21},"Fludarabine","Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg\u002Fm2\u002Fday IV (Day -5, Day -4, Day -3 ).",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"S Fadilah Abdul Wahid, MD, DrIntMed, PhD","CONTACT","+60391456450","sfadilah@ppukm.ukm.edu.my",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":21,"geoPoint":21,"contacts":46},"UKM Medical Centre","RECRUITING","Bandar Tun Razak","Kuala Lumpur","56000","Malaysia","MY",[47,48],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},{"name":49,"role":34,"phone":50,"phoneExt":21,"email":51},"Wan Fariza Wan Jamaludin, MD,DrIntMed","+60391457709","wanfariza@ppukm.ukm.edu.my",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Prof. Dr S Fadilah Abdul Wahid","Head of Pusat Terapi Sel \u002F Principal Investigator",[57],{"name":58,"class":6},"Gaia Science","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":70,"type":71},10,"ESTIMATED","INTERVENTIONAL",[74,75],"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",[78,79],"Relapsed B Acute Lymphoblastic Leukaemia","Refractory B Acute Lymphoblastic Leukaemia","2025-05-22",{"date":82,"type":83},"2025-05-29","ACTUAL",{"date":85,"type":83},"2019-03-19",{"date":87,"type":71},"2027-03-18",{"name":5,"class":6},1]