[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-acute-lymphocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-acute-lymphocytic-leukemia":39},{"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":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100538161",false,"NCT06287229","Phase Ib\u002FII Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed\u002FRefractory (R\u002FR) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab\u002FHCVAD-inotuzumab-blinatumomab","Inclusion Criteria:\n\n* Participants of age ≥18 years with documented relapsed or refractory B-cell ALL\n* In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:\n\n  1. KMT2A rearranged ALL\n  2. Complex cytogenetics as per NCCN 2022\n  3. Low-hypodiploidy\u002Ftetraploidy\n  4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)\n* Performance status of 0, 1, or 2\n* Adequate organ function with creatinine less than or equal to 1.6 mg\u002Fdl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal\n* Participants should be CD19 expression positive (\\>50%) before enrollment\n* Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I\u002FII will be eligible if they are on therapy and infections are under control.\n\nExclusion Criteria\n\n* Philadelphia positive B-cell ALL\n* Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization\n* Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy\n* Active and uncontrolled disease\u002Finfection as judged by the treating physician\n* Unable or unwilling to sign the consent form\n* No other investigational therapy within the past 14 days","ALL","18 Years",{"count":17,"type":18},40,"ESTIMATED","INTERVENTIONAL",[21,22],"PHASE1","PHASE2","To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed\u002Frefractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed\u002Frefractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.",[25,26],"Relapsed\u002FRefractory","B-cell Acute Lymphocytic Leukemia","RECRUITING","2026-04-21",{"date":30,"type":31},"2026-04-24","ACTUAL",{"date":33,"type":31},"2024-07-11",{"date":35,"type":18},"2030-12-31",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",""]