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临床试验/NCT00123487
NCT00123487已完成3 期

A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Bristol-Myers Squibb27 个研究点 分布在 2 个国家目标入组 638 人开始时间: 2005年6月最近更新:
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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
638
试验地点
27
主要终点
Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic 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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
  • •Men and women, 18 years of age 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
  • •Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2

排除标准

  • •Women who are pregnant or breastfeeding
  • •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
  • •Prior therapy with BMS-35425
  • •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

dasatinib Twice a Day (BID)

Experimental

70 mg dasatinib twice a day (BID)

干预措施: dasatinib (Drug)

dasatinib Once a Day (QD)

Experimental

140 mg dasatinib once a day (QD)

干预措施: dasatinib (Drug)

结局指标

主要结局

Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population

时间窗: Randomization up to 6 months

MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.

次要结局

  • Median Time to Major Hematologic Response (MaHR) - Randomized Population(Day 1 up to 6 months (time of primary endpoint), 2 years)
  • Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants(Baseline up to Year 2)
  • Number of Participants With Best Cytogenic Response (CyR) - Randomized Population(Randomization up to 6 Months, 2 Years)
  • Median Overall Survival (OS) - Randomized Population(Randomization up to 5 Years)
  • Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants(Baseline to Year 2)
  • Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population(Randomization up to 2 years)
  • Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population(Randomization up to 2 years)
  • Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population(Randomization up to 6 months, 2 years)
  • Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population(Randomization up to 6 Months, 2 Years)
  • Median Progression Free Survival (PFS) - Randomized Population(Randomization up to 5 Years)
  • Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population(24 months, 36 months, 48 months, 60 months)
  • Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations(Day 1 up to Year 7)
  • Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study(Day 1 up to 5 years)
  • Percent of Participants With Overall Hematologic Response - Randomized Population(Randomization up to 6 Months, 2 Years)
  • Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants(Day 1 to Year 7)
  • Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants(Baseline to Year 2)
  • Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants(Baseline to Year 2)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (27)

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