A Phase II, Multi-center, Open Label, Randomized Study of Ribavirin and Hedgehog Inhibitor With or Without Decitabine in Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Efficacy will be measured by overall response rate (ORR).
研究概览
简要总结
This is a research study of ribavirin which will be given in combination with vismodegib and/or decitabine. The purpose of this study is to see if patients respond to treatment when ribavirin is given with vismodegib alone or in combination with decitabine.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ribavirin, vismodegib
Ribavirin 1400mg BID, vismodegib 150mg QD
干预措施: Ribavirin (Drug)
Ribavirin, vismodegib
Ribavirin 1400mg BID, vismodegib 150mg QD
干预措施: Decitabine (Drug)
Ribavirin, vismodegib, decitabine
Decitabine 20mg/m2 IV QD days -7 to -3 for cycle 1. Ribavirin 1400mg BID and vismodegib 150mg QD starting on day 1. On subsequent cycles, decitabine will be administered on days 1 to 5.
干预措施: Ribavirin (Drug)
Ribavirin, vismodegib, decitabine
Decitabine 20mg/m2 IV QD days -7 to -3 for cycle 1. Ribavirin 1400mg BID and vismodegib 150mg QD starting on day 1. On subsequent cycles, decitabine will be administered on days 1 to 5.
干预措施: Vismodegib (Drug)
Ribavirin, vismodegib, decitabine
Decitabine 20mg/m2 IV QD days -7 to -3 for cycle 1. Ribavirin 1400mg BID and vismodegib 150mg QD starting on day 1. On subsequent cycles, decitabine will be administered on days 1 to 5.
干预措施: Decitabine (Drug)
结局指标
主要结局
Efficacy will be measured by overall response rate (ORR).
时间窗: Measured up to 2 years after the last subject has enrolled in the study.
次要结局
- Time to response(Measured up to 2 years after the last subject has enrolled in the study.)
- Duration of response(Measured up to 2 years after the last subject has enrolled in the study.)
- One year survival(Measured up to 2 years after the last subject has enrolled in the study.)
- Overall survival(Measured up to 3 years after the last subject has enrolled in the study.)
- Hematologic improvement defined by the number of individual, positively affected cell lines (erythroid, neutrophil and platelet cells) per patient.(Measured up to 2 years after the last subject has enrolled in the study.)
- Number of participants with Adverse Events as a Measure of Safety and Tolerability(Measured up to 2 years after the last subject has enrolled in the study.)
- Changes in eIF4E expression, localization, and signalling pathways (measured by immuno-histochemical analysis, PCR or western blot) and correlating with each patient's overall response.(Measured up to 2 years after the last subject has enrolled in the study.)
研究者
Sarit Assouline
Hematologist-oncologist
Jewish General Hospital