A Phase II Study of Omacetaxine (OM) and Decitabine (DAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safe Dose Combination of Omacetaxine (OM) and Decitabine (DAC)
研究概览
简要总结
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 2 groups of up to 6 participants (combined) will be enrolled in the Phase 1 portion of the study, and up to 60 participants will be enrolled in Phase 2.
If you are enrolled in Phase 1, the dose of decitabine you receive will depend on when you joined this study. If the first group of participants to receive decitabine has intolerable side effects, a second group will receive a lower dose.
If you are enrolled in Phase 2, you will receive decitabine at the highest dose that was tolerated in Phase 1.
All participants will receive the same dose level of omacetaxine.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated AML (>/= 20% blasts) or AML M
- •Patients with high-risk (intermediate-2 or high by IPSS or >/= 10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. No prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
- •Age >/= 70 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
- •Patients must be willing and able to review, understand, and provide written consent before starting therapy.
- •Men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation.
排除标准
- •New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure.
- •Myocardial infarction in the previous 12 weeks (from the start of treatment).
- •Active and uncontrolled disease/infection as judged by the treating physician.
- •Acute promyelocytic leukemia (APL).
研究组 & 干预措施
Omacetaxine + Decitabine
Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.
Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle.
Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.
干预措施: Omacetaxine (Drug)
Omacetaxine + Decitabine
Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.
Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle.
Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.
干预措施: Decitabine (Drug)
结局指标
主要结局
Safe Dose Combination of Omacetaxine (OM) and Decitabine (DAC)
时间窗: 28 days
Safe dose defined as highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during first treatment cycle. DLT defined as clinically significant Grade 3 or 4 adverse event or abnormal laboratory value according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study.
次要结局
- Complete Response Rate (CRR)(8 weeks)