A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- MMR rate at 12 months in two groups
研究概览
简要总结
This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •at the age of 18 or more
- •newly diagnosed within three months as a Chronic Myeloid Leukemia
- •with positive Philadelphia chromosome and appearance of BCR-ABL transcript
- •with 0 - 2 of ECOG Performance Status
- •with normal renal function
- •with normal hepatic function
- •able to understand and decide to involve the study
排除标准
- •history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
- •history of other clinically relevant malignant tumors
- •with bleeding disorders which are not related to leukemia
- •evidence of clinically relevant cardiac dysfunction
- •with severe disease which cannot be regulated by other organs
- •a previous administration of Imatinib more than a week prior to the first dose.
- •participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit
- •HIV-infected
- •females with pregnancy, childbearing or lactating potential
- •other reasons determined by investigators
研究组 & 干预措施
Group B
the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months.
干预措施: 600mg/day of Imatinib (Drug)
Group A
the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months.
干预措施: 400mg/day of Imatinib (Drug)
结局指标
主要结局
MMR rate at 12 months in two groups
时间窗: 12 months
MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.
次要结局
- CMR in group A and B(12 months)
- Survival rate in group A and B(12 months)
- MMR in group A and B(12 months)
- CCyR in group A and B(12 months)
- Progression rate to AP/BC in group A and B(12 months)
- the actual administration(12 months)