A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 502
- 试验地点
- 162
- 主要终点
- Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
研究概览
简要总结
Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.
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
- •Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
- •Diagnosis of CML chronic phase confirmed.
- •Adequate hepatic and renal function.
- •Able to take oral tablets.
排除标准
- •Exclusions include Philadelphia negative CML.
- •Prior anti-leukemia treatment.
- •Prior stem cell transplant.
研究组 & 干预措施
1
Bosutinib
干预措施: Bosutinib (Drug)
2
Imatinib
干预措施: imatinib (Drug)
结局指标
主要结局
Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
时间窗: Year 1 (48 weeks)
Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (\<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.
次要结局
- Percentage of Participants With Major Molecular Response (MMR) at Year 1(Year 1 (48 weeks))
- Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks(192 weeks)
- Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks(192 weeks)
- Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks(144 weeks)
- Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks(192 weeks)