[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357706":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":41,"interventions":50,"overallOfficials":34,"centralContacts":64,"locations":70,"responsibleParty":85,"collaborators":89,"id":92,"slug":34,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":34,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":34,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":34,"overallStatus":73,"whyStopped":34,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"National University of Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":34},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Overall response rate (ORR)","Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.","Participants will be followed for the duration of the treatment, with an expected average of 3 months.",{"measure":14,"description":15,"timeFrame":16},"Complete response (CR)","Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.","12 Months",{"measure":18,"description":15,"timeFrame":16},"CR with incomplete blood recovery (CRi).",[20,24,27,30],{"measure":21,"description":22,"timeFrame":23},"Overall survival (OS)","Overall Survival (OS) defined as the time from treatment to the date of death due to any cause.","12 Months, 24 Months",{"measure":25,"description":26,"timeFrame":23},"Progression free survival (PFS)","Progression Free Survival (PFS) defined as the time from treatment to first documentation of objective leukemic progression (date of leukaemia assessment documenting progressive disease) or to death due to any cause. Progression is assessed by BM biopsy or CSF analysis according to NCCN criteria. It is assessed at Day 30 and monthly thereafter, or earlier if clinically indicated.",{"measure":28,"description":29,"timeFrame":23},"Time to next treatment (TTNT)","Time To Next Treatment (TTNT) defined as the end of study treatment until the institution of the next therapy.",{"measure":31,"description":32,"timeFrame":33},"Percentage of adverse events","Percentage of participants with adverse events","30 days",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NA","SINGLE_GROUP","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"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.",[47,48,49],"Biological: CD19 CAR-T CELLS","Drug: Cyclophosphamide","Drug: Fludarabine",[51,55,60],{"type":52,"name":43,"description":53,"armGroupLabels":54,"otherNames":34},"BIOLOGICAL","CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.",[43],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"DRUG","Cyclophosphamide","Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg\u002Fm2\u002Fday IV(Day -5, Day -4, Day -3 ).",[43],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":34},"Fludarabine","Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg\u002Fm2\u002Fday IV (Day -5, Day -4, Day -3 ).",[43],[65],{"name":66,"role":67,"phone":68,"phoneExt":34,"email":69},"S Fadilah Abdul Wahid, MD, DrIntMed, PhD","CONTACT","+60391456450","sfadilah@ppukm.ukm.edu.my",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":34,"geoPoint":34,"contacts":79},"UKM Medical Centre","RECRUITING","Bandar Tun Razak","Kuala Lumpur","56000","Malaysia","MY",[80,81],{"name":66,"role":67,"phone":68,"phoneExt":34,"email":69},{"name":82,"role":67,"phone":83,"phoneExt":34,"email":84},"Wan Fariza Wan Jamaludin, MD,DrIntMed","+60391457709","wanfariza@ppukm.ukm.edu.my",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Prof. Dr S Fadilah Abdul Wahid","Head of Pusat Terapi Sel \u002F Principal Investigator",[90],{"name":91,"class":6},"Gaia Science","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":102,"type":103},10,"ESTIMATED","INTERVENTIONAL",[106,107],"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",[110,111],"Relapsed B Acute Lymphoblastic Leukaemia","Refractory B Acute Lymphoblastic Leukaemia","2025-05-22",{"date":114,"type":115},"2025-05-29","ACTUAL",{"date":117,"type":115},"2019-03-19",{"date":119,"type":103},"2027-03-18",{"name":5,"class":6},1]