[{"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":27},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100538161","phase-1-phase-ibii-study-assessing-the-clinical-activity-and-safety-of-brexucabtagene-autoleucel-as-a-consolidation-in-patients-with-relapsedrefractory-rr-and-newly-diagnosed-b-cell-acute-lymphocytic-leukemia-all-post-cytoreduction-with-mini-hcvd-inotuzumab-blinatumomabhcvad-inotuzumab-blinatumomab-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":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22,23],"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.",[26,27],"Relapsed\u002FRefractory","B-cell Acute Lymphocytic Leukemia","RECRUITING","2026-04-21",{"date":31,"type":32},"2026-04-24","ACTUAL",{"date":34,"type":32},"2024-07-11",{"date":36,"type":19},"2030-12-31",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER"]