A Randomized Phase Lll Study of Imatinib Dose Optimization Compared With Nilotinib in Patients With Chronic Myelogenous Leukemia and Suboptimal Response to Standard-dose Imatinib

There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.

目前尚无关于伊马替尼（imatinib）应答不佳患者实施剂量递增治疗的临床获益相关数据；且经5年随访的IRIS试验结果显示，维持标准剂量给药仍可改善此类患者的应答水平。然而，针对应答不佳患者群体使用尼洛替尼（nilotinib）的潜在获益，目前仍无相关研究数据。本研究将对比尼洛替尼400mg 一日两次（BID）与伊马替尼600mg 一日一次（QD）的疗效。