Historically, outcomes of adult patients with relapsed acute lymphoblastic leukemia (ALL) who fail to enter remission with conventional chemotherapy are very poor. Blinatumomab, a bispecific CD3/CD19 antibody, has shown remarkable activity in relapsed/refractory (r/r) ALL. Although allogeneic hematopoietic cell transplant (HCT) is the recommended consolidation therapy for patients with r/r ALL who respond to salvage therapy, HCT and toxicity outcomes for those who received blinatumomab salvage and HCT remain largely unknown. We treated 89 patients with r/r ALL with blinatumomab, of whom 43 patients (48%) achieved remission. Here we describe our single-center experience in the subset of patients who responded to blinatumomab salvage therapy for eradication of either gross (n = 24) or minimal residual disease (n = 11) before HCT. Overall survival at 1 and 2 years after allogeneic HCT was 77% and 52%, respectively. Leukemia-free survival at 1 and 2 years were 65% and 40%, respectively. Additionally, with blinatumomab administration pre-HCT, no unusual toxicities such as delayed neutrophil/platelet engraftment or graft failure were observed. Acute grades II to IV graft-versus-host disease (GVHD) at day +100 post-HCT was at 43% and 2-year chronic GVHD was 36%, both comparable with historic control subjects. Finally, results of our subset analysis based on pre-HCT minimal residual disease (MRD) status indicated no significant difference in survival outcomes among patients undergoing transplant in MRD-negative status and the entire cohort. In conclusion, based on results of this study, blinatumomab may be considered as a safe and effective agent for r/r ALL patients before HCT.

中文翻译：

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复发/难治性急性淋巴细胞白血病患者使用 Blinatumomab 挽救治疗后异基因造血细胞移植的结果。

从历史上看，复发性急性淋巴细胞白血病 (ALL) 成年患者在接受常规化疗后未能达到缓解的效果非常差。Blinatumomab 是一种双特异性 CD3/CD19 抗体，在复发/难治性 (r/r) ALL 中显示出显着的活性。尽管异基因造血细胞移植 (HCT) 是推荐用于对补救治疗有反应的 r/r ALL 患者的巩固治疗，但对于接受博纳吐单抗和 HCT 治疗的患者，HCT 和毒性结果仍很大程度上未知。我们用 blinatumomab 治疗了 89 名 r/r ALL 患者，其中 43 名患者 (48%) 达到了缓解。在这里，我们描述了我们在 HCT 前对 blinatumomab 补救治疗根除粗大 (n = 24) 或微小残留病 (n = 11) 的患者子集的单中心经验。异基因 HCT 后 1 年和 2 年的总生存率分别为 77% 和 52%。1 年和 2 年无白血病生存率分别为 65% 和 40%。此外，在 HCT 前使用 blinatumomab 给药，未观察到异常毒性，例如延迟中性粒细胞/血小板植入或移植失败。HCT 后 +100 天的急性 II 至 IV 级移植物抗宿主病 (GVHD) 为 43%，2 年慢性 GVHD 为 36%，两者均与历史对照组相当。最后，我们基于 HCT 前微小残留病 (MRD) 状态的子集分析结果表明，在 MRD 阴性状态下接受移植的患者与整个队列的生存结果没有显着差异。总之，根据本研究的结果，博纳吐单抗可被认为是 HCT 前 r/r ALL 患者安全有效的药物。