NCT01887561Unknown2 期
PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS
Kanto CML Study Group1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年11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
- 100
- 试验地点
- 1
- 主要终点
- The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
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
- Non Randomized
- 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
- 是
入选标准
- •Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
- •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.
- •female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
- •Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline
- •A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
研究组 & 干预措施
treatment
No Intervention
干预措施: dasatinib (Drug)
结局指标
主要结局
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
时间窗: by 12 months
次要结局
- 'Dasatinib affects immunological responses, as measured by flow cytometry(at 3,6,12,24 months)
- Major Molecular Response(MMR) rate measured by RQ-PCR(by 1 months, then every 6 months for 2 years)
- Complete Cytogenetic Response (CCyR) rate(by 6,12 months)
- Progression free survival (PFS)(Participants were followed for at least 2 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Participants were followed for at least 2 years)
- The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR(by 3,6 months)
- Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse(by 12 months after molecular relapse)
- Complete Molecular Response(CMR) rate measured by RQ-PCR(by 1 months, then every 6 months for 2 years)
研究者
Naoki Takezako, M.D., Ph.D.
Kanto CML Study Group
Kanto CML Study Group
研究点 (1)
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