[Translation] A phase 2, randomized, double-blind, phase 2, randomized, double-blind, trial comparing the efficacy and safety of oral azacitidine (CC-486) plus best supportive care versus best supportive care as maintenance therapy in Chinese patients with acute myeloid leukemia in complete remission placebo-controlled study
主要目的:
评价CC-486维持治疗与安慰剂相比是否可改善首次达到完全缓解(CR)或血细胞计数未完全恢复的完全缓解(CRi)的急性髓系白血病(AML)患者的无复发生存期(RFS);
次要目的:
确定CC-486维持治疗与安慰剂相比对首次达到CR/CRi的AML受试者的总生存期(OS)的影响;
确定CC-486维持治疗与安慰剂相比对首次达到CR/CRi的AML受试者其他疗效终点的影响;
评估CC-486在AML受试者中的安全性和耐受性;
表征CC-486在AML受试者中的药代动力学;
评价骨髓中残留病灶的预后和治疗意义;
确定CC-486与安慰剂相比对健康相关生活质量(HRQoL)和医疗资源利用的影响
[Translation] main purpose:
To evaluate whether CC-486 maintenance therapy improves relapse-free survival (RFS) compared with placebo in acute myeloid leukemia (AML) patients who first achieved complete remission (CR) or complete remission (CRi) with incomplete blood count recovery ;
Secondary purpose:
To determine the effect of CC-486 maintenance therapy versus placebo on overall survival (OS) in AML subjects achieving CR/CRi for the first time;
To determine the effect of CC-486 maintenance therapy compared with placebo on other efficacy endpoints in AML subjects achieving CR/CRi for the first time;
To evaluate the safety and tolerability of CC-486 in subjects with AML;
To characterize the pharmacokinetics of CC-486 in AML subjects;
To evaluate the prognosis and therapeutic significance of residual disease in the bone marrow;
To determine the effect of CC-486 compared to placebo on health-related quality of life (HRQoL) and healthcare resource utilization