M.D. Anderson Cancer Center
To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory 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/refractory 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.
Primary Objectives: To assess the Efficacy of Brexucabtagene autoleucel \[anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)\] in terms of EFS in patients with R/R and high-risk newly diagnosed B-cell acute lymphoblastic leukemia (B-cell ALL) post cytoreduction with mini-hyper-CVD-inotuzumab-blinatumomab/Hyper-CVAD-inotuzumab-blinatumomab The EFS will be estimated in terms of median EFS and 9-month EFS for the R/R cohort and 18-month EFS for the frontline cohort. Secondary Objectives: 1. 12 and 24-months overall survival (OS): 12 months for the R/R cohort and 24 months f…
Inclusion Criteria: * Participants of age ≥18 years with documented relapsed or refractory B-cell ALL * In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as: 1. KMT2A rearranged ALL 2. Complex cytogenetics as per NCCN 2022 3. Low-hypodiploidy/tetraploidy 4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions) * Performance status of 0, 1, or 2 * Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or eq…
Given by Infusion
Given by IV
Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.
Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD
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