An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Number of Participants With Major Molecular Response
研究概览
简要总结
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
详细描述
- Design:
Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor. Subjects currently enrolled in the trial will continue to receive dasatinib alone at a starting dose of 100 mg QD for:
- a maximum of 5 years after entry into the study
- until progression by Investigators determination/judgment
- intolerance to Dasatinib
- the study is terminated due to safety concerns or
- other administrative reasons as communicated by the sponsor
- Research Hypothesis :
The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor. The objective of the altered design of this study is to describe the safety profile and tolerability of dasatinib
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
- •Subjects ≥ 18 years of age who have signed informed consent
- •Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase
- •Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.
- •Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2
排除标准
- •Known Abl-kinase T315I or T315A mutation
- •Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
- •Prior chemotherapy.
- •Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
研究组 & 干预措施
Arm 1: Dasatinib
干预措施: Dasatinib (Drug)
Arm2: Dasatinib + BMS-833923
Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response
干预措施: Dasatinib (Drug)
Arm2: Dasatinib + BMS-833923
Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response
干预措施: BMS-833923 (Drug)
结局指标
主要结局
Number of Participants With Major Molecular Response
时间窗: Baseline up to 12 months
Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.
次要结局
- Complete Molecular Response at Any Time(Baseline to End of study (approximately 48 months))
- Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death(Baseline to End of study (approximately 48 months))
- Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation(Baseline to End of study (approximately 48 months))
- Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death(Baseline to End of study (approximately 48 months))
- Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death(From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months))