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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Cytogenetic Response (CCyR)
研究概览
简要总结
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.
详细描述
The comparative efficacy between imatinib dose escalation (600 mg QD) and nilotinib (400 mg BID), in terms of CCyR after 6 months, for patients with CML in chronic phase with suboptimal response to imatinib standard dose will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nilotinib
Participants received 400 mg nilotinib twice daily (BID).
干预措施: nilotinib (Drug)
Imatinib
Participants received 600 mg imatinib once daily (QD).
干预措施: imatinib (Drug)
结局指标
主要结局
Percentage of Participants With Complete Cytogenetic Response (CCyR)
时间窗: 6 months
CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.
次要结局
- Overall Survival (OS)(24 months)
- Percentage of Participants With CCyr(12 and 24 months)
- Percentage of Participants With Major Molecular Response (MMR)(12 and 24 months)
- Time to CCyR(24 months)
- Progression-Free Survival (PFS)(24 months)
- Event-Free Survival (EFS)(24 months)
- Duration of CCyR(24 months)