Abstract
This retrospective study evaluated the efficacy and safety of integrating blinatumomab and CD19 CAR T-cell therapy into frontline treatment for newly diagnosed adult Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. All patients received Hyper-CVAD-based consolidation with integrated immunotherapy. Forty patients were classified according to frontline immunotherapy strategy: single-modality therapy (BiTE/CART group, n = 22) or combined use of both modalities (BiTE + CART group, n = 18). After a median follow-up of 23.8 months, the BiTE + CART group demonstrated significantly improved overall survival and relapse-free survival compared with the BiTE/CART group (2-year overall survival: 100% vs. 58.4%; 2-year relapse-free survival: 94.4% vs. 53.1%). A higher cumulative exposure to immunotherapy (≥ 4 cycles) was associated with improved outcomes. Notably, survival in non-transplanted patients was comparable to those undergoing allogeneic transplantation in first remission. These findings support the integration of blinatumomab and CD19 CAR T-cell therapy as a promising strategy to improve disease control in Ph⁻ B-cell precursor acute lymphoblastic leukemia, pending validation in prospective studies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00277-026-07030-z.