Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of subjects that remain with RM3log after imatinib discontinuation
研究概览
简要总结
This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.
详细描述
Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.
The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.
BCR: breakpoint cluster region
ABL: abelson murine leukemia
RM3log: major molecular response, BCR-ABL level below 0.1% (IS)
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
- •Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
- •Treatment with imatinib for at least 36 months
- •BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months
排除标准
- •Previous allogeneic stem cell transplantation
- •Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
- •Imatinib dose escalation at any time, due to loss or inadequate response
- •BCR-ABL mutation
- •IS: International Scale
- •MR4log: molecular response of 4log or <0,1% (IS)
研究组 & 干预措施
Discontinuation
All subjects will discontinue imatinib
干预措施: imatinib discontinuation (Other)
结局指标
主要结局
Number of subjects that remain with RM3log after imatinib discontinuation
时间窗: 24 months
Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.
次要结局
- Number of subjects that recover MR3log after imatinib reintroduction(6 months)
- Analysis of immunological profile of all subjects(24 months)
- Safety and tolerability of imatinib discontinuation(24 months)