Study of Targeted Therapy Combined With Chemotherapy and Followed by CAR-T Cell Treatment in Adults Newly Diagnosed With Philadelphia Chromosome-Positive B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a new treatment approach for adults newly diagnosed with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia Ph ALL. This approach combines targeted molecular therapy with chemotherapy followed by CAR-T cell therapy as a consolidation treatment. The goal is to improve survival and quality of life by increasing remission depth and reducing chemotherapy cycles and related side effects. The treatment involves using overembatinib a tyrosine kinase inhibitor, venetoclax a BCL2 inhibitor, and reduced-intensity chemotherapy to achieve complete remission. After remission, patients receive a single infusion of second-generation murine-derived CD19 CAR-T cells with a co-stimulation domain of 4-1BB at a dose of 1106 CAR cells per kilogram. This sequence aims to shorten hospital stays and lower toxicity. The study includes only one treatment group receiving this combination and follows patients for up to 5 years. Participants will undergo regular assessments including disease-free survival DFS over 2 years, overall survival OS, event-free survival EFS, molecular remission rates, minimal residual disease remission, relapse rates, and treatment-related toxicities. Quality of life will also be monitored. Safety and efficacy outcomes are tracked through blood tests, imaging, and molecular analyses. The study started in June 2024 and is expected to continue through mid-2028, with ongoing follow-up visits throughout this period.

Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL