A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
试验速览
- 阶段
- 1 期
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
研究概览
简要总结
This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS
详细描述
This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
- •Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
- •ECOG performance status 0-2
- •Adequate renal function
- •Adequate liver function
- •Able to swallow capsules
- •Ability to understand and willingness to sign the informed consent form
排除标准
- •AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
- •Known central nervous system (CNS) involvement by leukemia
- •Uncontrolled intercurrent illness including
- •Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
- •Known to be HIV-positive
研究组 & 干预措施
Sapacitabine/decitabine (Part 1 - completed)
decitabine will be administered in alternating cycles with sapacitabine
干预措施: sapacitabine and decitabine (Part 1 - completed) (Drug)
sapacitabine/venetoclax (Part 2 - recruiting)
sapacitabine will be administered concomitantly with venetoclax
干预措施: sapacitabine and venetoclax (Part 2 - recruiting) (Drug)
结局指标
主要结局
Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
时间窗: 2 years
次要结局
- response duration(2 years)
- transfusion requirements(2 years)
- overall survival(2 years)
- hospitalized days(2 years)