Study of Reduced-Dose Chemotherapy and Full-Course Immunotherapy Using Blinatumomab for Newly Diagnosed Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia in Patients Aged 15 to 65

What this Trial Is About

Researchers are evaluating the effects of combining blinatumomab with chemotherapy in patients newly diagnosed with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia B-ALL. This single-arm, phase 2 trial aims to improve survival outcomes by using a reduced-dose chemotherapy plus full-course immunotherapy approach. The study focuses on enhancing remission rates, deepening minimal residual disease clearance, and monitoring relapse-free survival over two years. Participants receive an induction therapy consisting of reduced-dose chemotherapy combined with blinatumomab to improve remission and tolerability. This is followed by consolidation therapy with alternating Hyper-CVAD chemotherapy cycles, blinatumomab, and sequential CD19-directed CAR-T cell therapy. Selected patients with specific genetic markers or persistent disease may also undergo allogeneic hematopoietic stem cell transplantation. No maintenance therapy is planned after these treatments. During the study, patients will be closely monitored for response to treatment including remission and minimal residual disease status. Researchers will assess survival outcomes over a two-year period following enrollment of the last patient. The trial includes regular evaluations of blood counts, liver and kidney function, and overall health status to track safety and effectiveness. The total participation time includes the induction and consolidation phases with follow-up extending through two years post-treatment.

Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia