Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
研究概览
简要总结
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
详细描述
Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic phase CML not received treatment
- •Pts with no heart disease
- •Pts with no abnormal cholesterol level
排除标准
- •Any pts treated before with diff. Treatment
- •Pts. With past history of heart problems
- •Pts. With abnormal cholesterol level
研究组 & 干预措施
Chronic phase CML treated by nilotinib
Newly diagnosed
干预措施: Nilotinib 150 MG [Tasigna] (Drug)
Chronic phase CML treated by imatinib
Newly diagnosed
干预措施: Imatinib 400mg (Drug)
结局指标
主要结局
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
时间窗: 3 years cutoff
heart state by assessment by ECG
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
时间窗: 3 years cutoff
free survival rate in years
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
时间窗: 3 years cutoff
cholesterol level in mg
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
时间窗: 3 years cutoff
Overall survival rate in years
次要结局
未报告次要终点
研究者
Jean George Maxwell
ClinIcal professor
Assiut University