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临床试验/NCT02421926
NCT02421926撤回不适用

Extension Study of a 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

Asan Medical Center12 个研究点 分布在 1 个国家开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
12
主要终点
progression-free survival rate

研究概览

简要总结

This study is an extension study (prospective observational study) of 'IDEAL' study (A 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, NCT02204722) to evaluate the duration of treatment response, disease progression, and survival status up to 5 years after the inclusion.

详细描述

We have started a prospective study of evaluating efficacy and safety of imatinib 600mg/day depending on early molecular response in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (IDEAL, NCT02204722), which will enroll 150 patients and follow up them for 1 years for the purpose of evaluating the primary endpoints - difference of major molecular response rate at 1 year. However, Chronic myelogenous is a disease which needs long-term for the outcome of treatment with BCR-ABL tyrosine kinase inhibitor. After the end of follow-up period of IDEAL study, subjects who agree with this extension study (IDEAL-E) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. Subjects who will be enrolled in this prospective observational study will be treated with drugs - imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg - which has been chosen by the each investigator according to the drug compliance and overall response. The drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, were enrolled to 'IDEAL study (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, NCT02204722)
  • Subjects who agreed with the participation of this study after informed consent

排除标准

  • Patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, agree with the participation to 'IDEAL study (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, NCT02204722) after informed consent, but were excluded finally from the 'IDEAL' study

研究组 & 干预措施

IDEAL-E observational group

Subjects who were newly diagnosed as chronic phase chronic myelogenous leukemia, were enrolled to 'IDEAL' study, finished the total study period of 'IDEAL' study or were dropped during the study period.

干预措施: IDEAL-E observation (investigators choice of imatinib, nilotinib, dasatinib, radotinib) (Drug)

结局指标

主要结局

progression-free survival rate

时间窗: 5-year

次要结局

  • failure-free survival rate(5-year)
  • cumulative incidence of progression to accelerated phase / blast crisis(5-year)
  • overall survival(5-year)
  • progression-free survival rate(2-year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyoo-Hyung Lee

Professor

Asan Medical Center

研究点 (12)

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