[Translation] A phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of picolipid acetate injection in patients with relapsed/refractory acute leukemia
主要目的:1) 评价注射用醋酸吡可利布在复发/难治性白血病患者中的安全性和耐受性;2) 评估注射用醋酸吡可利布的剂量限制性毒性(DLT)和最大耐受剂量(MTD);3) 确定II期给药方案。次要目的:1) 评价注射用醋酸吡可利布在复发/难治性白血病患者中的药代动力学(PK)特性;2) 评估注射用醋酸吡可利布在复发/难治性白血病患者中的初步疗效。
[Translation] Primary objectives: 1) To evaluate the safety and tolerability of picolipid acetate injection in patients with relapsed/refractory leukemia; 2) To assess the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of picolipid acetate injection; 3) To determine the Phase II dosing regimen. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) properties of picolipid acetate injection in patients with relapsed/refractory leukemia; 2) To evaluate the preliminary efficacy of picolipid acetate injection in patients with relapsed/refractory leukemia.