【摘要】 目的 评估白细胞分化抗原嵌合抗原受体T细胞(CD19 CAR-T)免疫疗法治疗前行异基因造血干细胞移植(allo-HSCT)对复发/难治性急性B淋巴细胞白血病(r/r B-ALL)患者疗效和安全性的影响。方法 收集该院2015年6月至2019年6月行同种CD19 CAR-T免疫疗法治疗的r/r B-ALL患者资料。根据治疗前是否行allo-HSCT,分为移植组和非移植组。比较2组患者的总缓解率(ORR)、无复发生存期(RFS)、总生存期(OS)及一般不良事件、特殊不良反应发生情况等。结果 共选取47例采用同种CD19 CAR-T免疫治疗的r/r B-ALL患者，其中9例在治疗前接受过allo-HSCT。移植组和非移植组的ORR分别为88.9%、78.9%,2组比较差异无统计学意义(P=0.667)。排除CD19 CAR-T治疗后桥接allo-HSCT治疗的患者，移植组与非移植组比较，中位RFS分别为386(434,237)、95 (168,37)d(Wilcoxon检验，P=0.028;Log-Rank检验，P=0.231);1年RFS率分别为62.5%、20.0%(P=0.068);中位OS分别为852(1 168,590)、222(809,141)d(Wilcoxon检验，P=0.049;Log-Rank检验，P=0.186);1年OS率分别为77.8%、35.7%(P=0.052)。输注CD19 CAR-T后的4周内，移植组和非移植组的一般不良事件及特殊不良反应发生率比较，差异均无统计学意义(P>0.05)。结论 CD19 CAR-T免疫治疗前曾接受过allo-HSCT的B-ALL患者可能获得更好的生存期，且不良反应未增加。更多还原

【Abstract】 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.更多还原