NCT01627132Unknown2 期
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
Shimousa Hematology Study Group1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
研究概览
简要总结
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Myeloid Leukemia in the Chronic Phase.
- •Patients with BCR-ABL-negative checks.
- •15 years old over.
- •ECOG performance status (PS) score 0-
- •Adequate organ function (hepatic, renal and lung).
- •Signed written informed consent.
排除标准
- •A case with the double cancer of the activity.
- •Women who are pregnant or breastfeeding.
- •Patients with complications or a history of severe.
- •Patients with mutation of T315I、F317L、V299L.
- •Patients with additional chromosome abnormalities.
- •The case of Pleural effusion with poor control.
- •Patients with a history of hematopoietic stem cell transplantation.
研究组 & 干预措施
dasatinib
Experimental
干预措施: Dasatinib (Drug)
结局指标
主要结局
The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
时间窗: at 12 months
次要结局
- Rate of complete molecular remission that will be sustained after dasatinib rechallenge.(at 12 months)
研究者
Koiti Inokuchi,MD,PhD.
Nippon Medical School
Shimousa Hematology Study Group
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS TrialMyelogenous Leukemia, Chronic, Chronic PhaseNCT01887561Kanto CML Study Group100
招募中
2 期
Dasatinib discontinuation for Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remission.JPRN-UMIN000008999Epidemiological and Clinical Research Information Network(ECRIN)50
已完成
2 期
Dasatinib discontinuation for Chronic Myelogenous Leukemia-Chronic Phase with One Year Complete Molecular Remission.chronic myeloid leukemiaJPRN-UMIN000005130Epidemiological and Clinical Research Information Network (ECRIN)50
已完成
2 期
Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter Stop Imatinib in Japan adult leukemia study group studyChronic Myeloid Leukemia Chronic phaseJPRN-UMIN000011971Japan Adult Leukemia Study Group62
已完成
不适用
PhaseII study of Dasatinib in patients with chronic myeloid leukemia after Imatinib failureChronic Myeloid Leukemia (chronic phase)JPRN-UMIN000001900Inter-Michinoku Dasatinib Study(IMIDAS)60