Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Major molecular response
研究概览
简要总结
The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.
The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
- •Patients with grade II or higher adverse events.
- •CML patients not suitable for stem cell transplantation.
排除标准
- •Patients in blast crisis.
- •Pregnant women
- •Patients without a contraception method.
研究组 & 干预措施
Imatinib and nilotinib combination
All patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months.
干预措施: Imatinib and Nilotinib (Drug)
结局指标
主要结局
Major molecular response
时间窗: 6 months
Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.
次要结局
- Drugs adverese effects(6 months)
研究者
David Gomez Almaguer
MD
Hospital Universitario Dr. Jose E. Gonzalez