Prospective Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Achieved Deep Molecular Response With Tyrosine Kinase Inhibitors in Real Life Setting in Argentina - (Argentine Stop Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Molecular relapse free survival during 24 months
研究概览
简要总结
The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.
详细描述
ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI)
Primary Objective:
- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI.
Secondary objectives:
- To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption.
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 99 Years（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
CML patient TKI discontinuation study
Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors
干预措施: Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment (Drug)
结局指标
主要结局
Molecular relapse free survival during 24 months
时间窗: 24 months
Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR. RQ PCR (IS) \>0.1% BCR ABL will be considered as loss of MMR
次要结局
- Treatment-free survival during 24 months(24 months)
研究者
Carolina Pavlovsky
Chief of Clinical Research Area
Fundaleu