A Phase I Combination Study of CYC065 and Venetoclax in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS
详细描述
This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
- •Adequate renal function
- •Adequate liver function
- •INR <=1.2 in patients not receiving chronic anticoagulation
- •At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
- •Agree to practice effective contraception
排除标准
- •AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
- •Known AML involvement in CNS that is symptomatic and active
- •Currently receiving radiotherapy, biological therapy, or any other investigational agents
- •Uncontrolled intercurrent illness
- •Pregnant or lactating
- •Known to be HIV-positive
- •Known active hepatitis B and/or hepatitis C infection
研究组 & 干预措施
CYC065 and venetoclax
CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.
干预措施: CYC065 (Drug)
CYC065 and venetoclax
CYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: At the end of cycle 1 (each cycle is 28 days)
Number of patients who experience dose-limiting toxicity (DLT)
次要结局
- Pharmacodynamic effect(At the end of cycle 1 (each cycle is 28 days))
- Pharmacokinetic effect(At the end of cycle 1 (each cycle is 28 days))