Severe toxicity and poor efficacy of reinduction chemotherapy are associated with overall poor outcomes in relapsed B-cell acute lymphoblastic leukemia: a report from the Children's Oncology Group AALL1331 trial.

High/intermediate-risk patients were subsequently randomized to receive two blocks of chemotherapy or two blocks of blinatumomab followed by a hematopoietic stem cell transplant.

高/中等风险患者随后被随机分配接受两个化疗周期或两个blinatumomab周期治疗，随后进行造血干细胞移植。

Low-risk patients were randomized to chemotherapy or chemotherapy cycles intercalated with three blinatumomab blocks.

低危患者被随机分配接受化疗或在化疗周期间插入三次blinatumomab治疗块。

Patients who had early treatment failure were eligible to receive blinatumomab for up to two salvage cycles.

早期治疗失败的患者有资格接受多达两个blinatumomab的挽救治疗周期。

We reviewed Block 1 responses, risk stratification, randomization rates, adverse events, event-free survival and overall survivalfor all enrolled patients.

我们回顾了所有入组患者的Block 1反应、风险分层、随机化率、不良事件、无事件生存和总生存。

AALL1331 enrolled 661 patients: 24 died during Block 1 and 42 experienced early treatment failure.

AALL1331共入组了661名患者：其中24人在Block 1期间死亡，42人经历了早期治疗失败。

Overall, 531/661 (80.3%) attained complete remission with 586 risk-assigned and only 471 were randomized.

总体而言，661名患者中有531名（80.3%）达到了完全缓解，共有586名患者进行了风险评估，但只有471名被随机分配。

Of 532 patients with bone marrow involvement, 290 (54.5%) were positive for minimal residual disease (≥0.01%) after Block 1.

在532名骨髓受累的患者中，有290名（54.5%）在Block 1后对微量残留病（≥0.01%）呈阳性。

Grade 3, 4 or 5 adverse events occurred in Block 1 in 44.9%, 24.1%, and 3.6% of patients, respectively, with febrile neutropenia, infections, and sepsis being most frequent.

在第一阶段治疗中，分别有44.9%、24.1%和3.6%的患者出现了3级、4级或5级不良事件，其中发热性中性粒细胞减少症、感染和败血症最为常见。

Notably, 190 enrolled patients (28.7%) did not proceed with post-induction therapy, including 115 (17.4%) risk-stratified but not randomized.

值得注意的是，有190名入组患者（28.7%）没有进行诱导后治疗，其中包括115名（17.4%）进行了风险分层但未随机化的患者。

These patients had dismal survival. More effective and less toxic reinduction strategies are needed for B-cell acute lymphoblastic leukemia in first relapse.

这些患者的生存情况非常糟糕。对于首次复发的B细胞急性淋巴细胞白血病，需要更有效且毒性更低的再诱导策略。

Trial registration number: NCT02101853.

试验注册编号：NCT02101853。