allo-HSCT 后复发/难治性 B-ALL 患者行 CD19CAR-T 治疗的疗效及安全性.

Objective To evaluate the efficacy and safety of allogeneic hematopoietic stem cell transplantation (allo-HSCT) before leukocyte differentiation antigen (CD19) chimeric antigen receptor T cell (CD19 CAR-T) immunotherapy in patients with relapse/refractory B lymphoblastic leukemia (r/r B-ALL) . Methods The data of r/r B-ALL patients treated with homologous CD19 CAR-T in this hospital from June 2015 to June 2019 were collected. According to whether allo-HSCT was performed before treatment, the patients were divided into the transplantation group and the non-transplantation group. The overall response rate (ORR),relapse-free survival time (RFS),overall survival time (OS) and general adverse events, special adverse reactions were compared between the two groups. Results A total of 47 r/r B-ALL patients treated with homologous CD19 CAR-T were screened, of which nine were treated with allo-HSCT before the treatment. The ORR of the transplant group and the non-transplant group was 88.9% and 78. 9%,respectively, and the difference was not significant (P=0. 667) . After excluded patients treated with bridging allo-HSCT after CD19 CAR-T immuno therapy, the median RFS were 386 (434,237) d and 95 (168,37) d (Wilcoxon test, P=0.028; Log-Rank test, P=0. 231) ; the first year RFS rates were 62. 5% and 20.0%,respectively (P=0. 068) ; the median OS were 852 (1 168,590) d and 222 (809,141) d (Wilcoxon test, P=0. 049; Log-Rank test, P=0.186) ; the first year OS rates were 77. 8% and 35. 7% (P=0.052) in the transplant group and the non-transplant group. Within four weeks after CD19 CAR-T infusion, there was no significant difference in the incidence of general adverse events or specific adverse reactions between the transplant group and the non-transplant group (P＞0.05) . Conclusion B-ALL patients who received allo-HSCT prior to CD19 CAR-T immuno therapy may achieve better survival without increased adverse reactions. [ABSTRACT FROM AUTHOR]