[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538161":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":64,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":23,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":23,"enrollmentInfo":74,"targetDuration":23,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":23,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1B + Phase 2","EXPERIMENTAL","Participants found to be eligible to take part in this study, you will be assigned to a study phase (Phase 1B or Phase 2). Up to 10 participants will be enrolled in Phase 1B, and up to 30 will be enrolled in Phase 2. All participants will first receive cytoreductive therapy (inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD), followed by lymphodepletion chemotherapy and 1 dose of brexucabtagene autoleucel.",[13,14,15,16],"Drug: Blinatumomab","Drug: Inotuzumab Ozogamicin","Drug: Hyper-CVAD","Drug: Mini-hyper-CVD",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Blinatumomab","Given by Infusion",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Inotuzumab Ozogamicin","Given by IV",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Hyper-CVAD","Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Mini-hyper-CVD","Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD",[9],[37],{"name":38,"affiliation":5,"role":39},"Elias Jabbour, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},"CONTACT","(713) 792-4764","ejabbour@mdanderson.org",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-95.36327,29.76328,{"lat":58,"lon":57},[61,63],{"name":38,"role":42,"phone":62,"phoneExt":23,"email":44},"713-792-4764",{"name":38,"role":39,"phone":23,"phoneExt":23,"email":23},{"type":65,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79,80],"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.",[83,84],"Relapsed\u002FRefractory","B-cell Acute Lymphocytic Leukemia","2026-04-21",{"date":87,"type":88},"2026-04-24","ACTUAL",{"date":90,"type":88},"2024-07-11",{"date":92,"type":76},"2030-12-31",{"name":5,"class":6},1]