Safety run-in and part 1 of GIMEMA AML1718: venetoclax combined with FLAI as induction treatment in non-low-risk AML.

We conducted a multicenter study phase 1b/2, Gruppo Italiano Malattie EMatologiche dell'Adulto AML1718, to investigate the safety and efficacy of venetoclax (VEN) combined with fludarabine, cytarabine, and idarubicin (V-FLAI) as an induction therapy for patients with non-low-risk AML aged <65 years and at intermediate or high European LeukemiaNet risk.

我们进行了一项多中心研究，即Gruppo Italiano Malattie EMatologiche dell'Adulto AML1718的1b/2期研究，以调查Venetoclax（VEN）联合氟达拉滨、阿糖胞苷和伊达比星（V-FLAI）作为非低风险AML患者（年龄<65岁，处于中度或高欧洲白血病网络风险）的诱导治疗的安全性和有效性。

After a safety run-in, patients were randomly allocated to VEN 400 mg or VEN 600 mg cohorts.

经过安全启动期后，患者被随机分配到VEN 400 mg或VEN 600 mg组。

The primary objectives were safety and composite complete remission (bone marrow blasts of <5% with any recovery).

主要目标是安全性和综合完全缓解（骨髓中原始细胞<5%且任何恢复）。

We report a predefined interim analysis after 57 patients.

我们在57名患者后报告了预定义的中期分析。

Median exposure to VEN during induction was 22 days.

诱导期间VEN的中位暴露时间是22天。

Effectiveness and safety were similar between VEN 400 mg and VEN 600 mg cohorts.

VEN 400 mg组和VEN 600 mg组的有效性和安全性相似。

The 60-day mortality rate was 5.8%.

60天的死亡率为5.8%。

Prolonged aplasia was observed in patients receiving high doses of cytarabine during consolidation.

在接受高剂量阿糖胞苷巩固治疗的患者中观察到持续的无细胞期。

Composite CR was achieved in 84% of patients.

84%的患者实现了复合完全缓解。

With a median follow-up of 20.6 months, 1-year overall survivalwas 71%, 1-year disease-free survival was 66.2%, and 1-year cumulative incidenceof relapse was 24%.

中位随访时间为20.6个月，1年总生存率为71%，1年无病生存率为66.2%，1年复发累积发生率为24%。

V-FLAI is an effective induction therapy for young and fit patients.

V-FLAI是针对年轻且体能良好的患者的有效诱导治疗方案。

Fifty-five more patients will be enrolled in part 2; they will receive VEN 400 mg + FLAI as predefined and will be evaluated centrally for measurable residual disease.

第二部分将有55名患者入组；他们将接受VEN 400 mg + FLAI的预定方案治疗，并将接受中心评估以确定可测量的残留疾病。

This trial was registered at www.clinicaltrials.gov as #NCT03455504.

该试验已在www.clinicaltrials.gov上注册，注册号为#NCT03455504。