[Translation] A Phase I, open-label, multicenter study to evaluate the pharmacokinetics, safety, tolerability, and efficacy of Uproleselan in combination with chemotherapy in Chinese subjects with relapsed or refractory acute myeloid leukemia
本研究的主要目的:
描述Uproleselan在中国复发或难治性急性髓系白血病(AML)受试者中的药代动力学(PK)特征;
评价Uproleselan联合化疗的安全性和耐受性。
次要目的:
描述Uproleselan联合化疗所到达的总生存期(OS);
描述Uproleselan联合化疗获得的缓解率(完全缓解[CR]率、CR/完全缓解伴有全血细胞计数不完全恢复[CRi]、CR/完全缓解伴有部分计数恢复[CRh]);
描述Uproleselan联合化疗诱导期重度口腔粘膜炎的发生率及持续时间,巩固期重度口腔粘膜炎的发生率及持续时间。
[Translation] The primary objectives of this study are:
To describe the pharmacokinetic (PK) characteristics of Uproleselan in Chinese subjects with relapsed or refractory acute myeloid leukemia (AML);
To evaluate the safety and tolerability of Uproleselan combined with chemotherapy.
Secondary objectives:
To describe the overall survival (OS) achieved by Uproleselan combined with chemotherapy;
To describe the remission rate (complete remission [CR] rate, CR/complete remission with incomplete recovery of complete blood counts [CRi], CR/complete remission with partial recovery of complete blood counts [CRh]) achieved by Uproleselan combined with chemotherapy;
To describe the incidence and duration of severe oral mucositis during the induction phase of Uproleselan combined with chemotherapy, and the incidence and duration of severe oral mucositis during the consolidation phase.