Allogeneic stem cells transplantation in children, adolescents and young adults previously treated by tisagenlecleucel for B-cell precursor acute lymphoblastic leukemia: a French retrospective SFGM-TC study.
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BACKGROUND: Tisagenlecleucel have transformed the prognosis of relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) in children, adolescents and young adults (AYA). However, 50% of patients relapse. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) after CAR-T cells should be considered in case of relapse or lack of CAR-T cell persistence. OBJECTIVES: This study aims to identify current indications of allo-HSCT after tisagenlecleucel in real world clinical practice and describe outcomes of patients. STUDY DESIGN: This national retrospective study included children/AYA with allo-HSCT after CAR-T cells (tisagenlecleucel) for R/R B-ALL in SFCE (French society for childhood and adolescents cancers and leukemias) centers in France. RESULTS: Forty patients underwent allo-HSCT post-CAR-T therapy for early failure/relapse (n=23), B-cell aplasia (BCA) loss (n=13), persistent cytopenia (n=2), and consolidation (n=2). Twelve patients had previously undergone allo-HSCT. Two-year relapse-free survival (RFS) was 46% (95% CI: 32-66%), overall survival (OS) 57% (95% CI: 43-76%), cumulative incidence of relapse (CIR) 31% (95% CI: 16-47%), and non-relapse mortality (NRM) 23% (95% CI: 11-37%). Ten patients died in complete remission from complications. In multivariate analysis, BCA loss was associated with better OS (77%, 95% CI: 57-100%; hazard ratio (HR) = 0.30; p = 0.046). High tumor burden before CAR T-cells was associated with higher CIR (HR=10.43; p=0.026). Prior allo-HSCT did not significantly impact survival. CONCLUSION: Allo HSCT post-CAR-T is feasible and offers a more favorable outcomes in BCA loss cases. However high NRM remains a major concern. This study allows to identify patients who require more monitoring after allo HSCT or alternative strategies in case of relapse after CAR T cells.