An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 547
- 试验地点
- 2
- 主要终点
- Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
研究概览
简要总结
The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female, aged 18 years and older
- •Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
- •Eastern Cooperative Oncology Group Performance Status score of 0-2
排除标准
- •Pleural Effusion
- •Uncontrolled cardiovascular disease
- •Significant bleeding disorder unrelated to CML
- •Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea
研究组 & 干预措施
Dasatinib
干预措施: Dasatinib (Drug)
Imatinib
干预措施: Imatinib (Drug)
结局指标
主要结局
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
时间窗: Pretreatment, every 3 months up to 12 months
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
次要结局
- Time to Confirmed Complete Cytogenic Response (cCCyR) Overall(Day 1 to 5 years)
- Percentage of Participants With Major Molecular Response (MMR) at Any Time(Planned total follow-up duration of 5 years)
- Percentage of Participants With Progression-free Survival (PFS)(Participants were followed-up for at least 5 years)
- Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)(Years 2, 3, 4 and 5)
- Time to Major Molecular Response (MMR) Overall(Day 1 to 5 years)
- Percentage of Participants With Overall Survival (OS)(Participants were followed-up for at least 5 years)