[Translation] A multicenter, dose-escalation and dose-expansion phase I/II study of the safety, tolerability, pharmacokinetics and preliminary efficacy of XY0206 tablets combined with chemotherapy in treatment-naïve acute myeloid leukemia subjects with FLT3-ITD mutations
Ⅰ期剂量递增: 研究目的: 1、评估XY0206片联合DA(柔红霉素+阿糖胞苷)治疗FLT3-ITD突变的初治AML受试者的安全性和耐受性,观察剂量限值性毒性(DLT),确定Ⅱ期推荐剂量(RP2D); 2、评估XY0206片联合DA(柔红霉素+阿糖胞苷)治疗FLT3-ITD突变的初治AML受试者的药代动力学(PK)特征; 3、评估XY0206片联合DA(柔红霉素+阿糖胞苷)治疗FLT3-ITD突变的初治AML受试者的初步疗效(如可获得)。 Ⅱ期随机对照研究: 研究目的: 1、比较XY0206片联合DA(柔红霉素+阿糖胞苷)与安慰剂联合DA治疗FLT3-ITD突变的初治AML受试者的疗效; 2、比较XY0206片联合DA(柔红霉素+阿糖胞苷)与安慰剂联合DA治疗FLT3-ITD突变的初治AML受试者的安全耐受性; 3、评估XY0206片联合DA(柔红霉素+阿糖胞苷)治疗FLT3-ITD突变的初治AML受试者的药代动力学(PK)特征。
[Translation] Phase I dose escalation: Study objectives: 1. To evaluate the safety and tolerability of XY0206 tablets combined with DA (daunorubicin + cytarabine) in the treatment of first-line AML subjects with FLT3-ITD mutations, observe dose-limiting toxicity (DLT), and determine the recommended Phase II dose (RP2D); 2. To evaluate the pharmacokinetic (PK) characteristics of XY0206 tablets combined with DA (daunorubicin + cytarabine) in the treatment of first-line AML subjects with FLT3-ITD mutations; 3. To evaluate the preliminary efficacy of XY0206 tablets combined with DA (daunorubicin + cytarabine) in the treatment of first-line AML subjects with FLT3-ITD mutations (if available). Phase II randomized controlled study: Study objectives: 1. To compare the efficacy of XY0206 tablets combined with DA (daunorubicin + cytarabine) and placebo combined with DA in the treatment of first-time AML subjects with FLT3-ITD mutations; 2. To compare the safety and tolerability of XY0206 tablets combined with DA (daunorubicin + cytarabine) and placebo combined with DA in the treatment of first-time AML subjects with FLT3-ITD mutations; 3. To evaluate the pharmacokinetic (PK) characteristics of XY0206 tablets combined with DA (daunorubicin + cytarabine) in the treatment of first-time AML subjects with FLT3-ITD mutations.