Efficacy and safety of currently approved and lower starting doses of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukemia: a phase IV study.

Previous studies reported higher rates of post-hematopoietic stem cell transplant (HSCT) hepatic sinusoidal obstruction syndrome (SOS) in patients receiving InO than in those receiving chemotherapy prior to HSCT.

先前的研究报告称，在接受InO治疗的患者中，造血干细胞移植（HSCT）后肝窦阻塞综合征（SOS）的发生率高于接受HSCT前化疗的患者。

It is unknown whether a lower InO dose would reduce the risk of post-HSCT SOS or affect efficacy.

尚不确定降低InO剂量是否会降低异基因造血干细胞移植（HSCT）后发生肝窦阻塞综合征（SOS）的风险或影响疗效。

This study evaluated efficacy and safety of the currently approved InO starting dose and a lower dose in adults with R/R ALL who were eligible for HSCT and were identified as being at higher risk of post-HSCT SOS.

本研究评估了目前批准的InO起始剂量和较低剂量在符合异基因造血干细胞移植（HSCT）条件且被识别为移植后肝窦阻塞综合征（SOS）高风险的复发/难治性急性淋巴细胞白血病（R/R ALL）成人患者中的疗效和安全性。

This open-label, phase IV study (NCT03677596) had two phases: in the run-in phase patients received InO at 1.2 mg/m2/cycle (N=22); in the randomized phase patients received InO starting at dose levels of 1.8 mg/m2/cycle (N=38) or 1.2 mg/m2/cycle (N=42).

这项开放标签、IV期研究（NCT03677596）分为两个阶段：在启动阶段，患者接受了1.2 mg/m2/周期的InO治疗（N=22）；在随机化阶段，患者开始接受1.8 mg/m2/周期（N=38）或1.2 mg/m2/周期（N=42）的InO治疗。

Primary endpoints were rate of SOS and rate of hematologic remission.

主要终点是SOS的发生率和血液学缓解率。

Overall, SOS was reported in ten patients (9.8%) and in all cases was post-HSCT SOS.

总体而言，有十名患者（9.8%）报告了SOS，所有病例均为移植后SOS。

In patients who proceeded to HSCT, post-HSCT SOS rates were 20%, 28.6%, 25.8%, and 16.7% in 1.2 mg/m2/cycle (run-in), 1.2 mg/m2/cycle (randomized), 1.2 mg/m2/cycle (run-in and randomized), and 1.8 mg/m2/cycle (randomized) InO dosing subgroups, respectively.

在进行HSCT的患者中，移植后SOS的发生率分别为：1.2 mg/m2/周期（启动期）组为20%，1.2 mg/m2/周期（随机化）组为28.6%，1.2 mg/m2/周期（启动期和随机化）组为25.8%，以及1.8 mg/m2/周期（随机化）InO剂量亚组为16.7%。

The rates of complete remission with or without complete hematologic recovery were 50.0%, 83.3%, 71.9%, and 68.4% in the respective subgroups.

在各个亚组中，完全缓解率（无论是否伴有完全血液学恢复）分别为50.0%，83.3%，71.9%和68.4%。

The study found that a starting dose of the 1.2 mg/m2/cycle demonstrated efficacy and safety consistent with those of the recommended 1.8 mg/m2/ cycle dose in adults with R/R ALL who were eligible for HSCT and had a higher risk of post-HSCT SOS.

研究发现，对于适合接受造血干细胞移植（HSCT）且移植后发生肝静脉闭塞病（SOS）风险较高的复发/难治性急性淋巴细胞白血病（R/R ALL）成人患者，起始剂量为1.2 mg/m2/周期的药物显示出与推荐剂量1.8 mg/m2/周期相当的有效性和安全性。