NCT00123474已完成3 期
A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
Bristol-Myers Squibb41 个研究点 分布在 2 个国家目标入组 724 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 724
- 试验地点
- 41
- 主要终点
- Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
研究概览
简要总结
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- •Men and women, 18 years or older
- •Adequate hepatic function
- •Adequate renal function
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
排除标准
- •Women who are pregnant or breastfeeding
- •Subjects who are eligible and willing to undergo transplantation during the screening period
- •A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- •Uncontrolled or significant cardiovascular disease
- •Medications that increase bleeding risk
- •Medications that change heart rhythms
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- •History of significant bleeding disorder unrelated to CML
- •Concurrent incurable malignancy other than CML
- •Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
研究组 & 干预措施
1
Experimental
干预措施: dasatinib (Drug)
2
Experimental
干预措施: dasatinib (Drug)
3
Experimental
干预措施: dasatinib (Drug)
4
Experimental
干预措施: dasatinib (Drug)
结局指标
主要结局
Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
时间窗: 6 months
Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
次要结局
- Time to MCyR in Participants With MCyR at 6 Months Follow-Up(6 months)
- Time to CHR in Participants With CHR at 6 Months Follow-Up(6 months)
- Time to MCyR in Participants With MCyR at 24 Months Follow-Up(24 months)
- Time to CHR in Participants With CHR At 24 Months Follow-Up(24 months)
- Number of Participants With MCyR Whose Disease Progressed by 24 Months(24 months)
- Number of Participants With CHR Whose Disease Progressed by 24 Months(24 months)
- Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants(Baseline up to 24 months)
- Percent of Participants With MCyR At or Prior to 24 Months Follow-Up(24 months)
- Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up(6 months, 24 months)
- Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up(24, 36, 48, 60, 72, and 84 months)
- Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up(24, 36, 48, 60, 72, and 84 months)
- Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose(6 months, 24 months)
- Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up(6 months, 24 months)
- Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up(24, 36, 48, 60, 72, and 84 months)
- Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up(24, 36, 48, 60, 72, and 84 months)
- Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up(6 months)
- Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up(24 months)
- Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants(24, 36, 48, 60, 72, and 84 months)
- Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants(24, 36, 48, 60, 72, and 84 months)
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up(Baseline to 30 days post last dose, up to 24 months)
- Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up(Baseline to 30 days post last dose, up to 7 years (study closure July 2014))
研究者
研究点 (41)
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