A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Remission (CR)
研究概览
简要总结
The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.
详细描述
Study Drugs:
Omacetaxine is designed to block certain proteins, which may cause cancer cells to die.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive omacetaxine and cytarabine as an injection under the skin. You will receive instructions on how to give these injections to yourself. You will be given a Research Medication Diary to record the drugs you take each day. You must bring the Research Medication Diary and any unused drugs with you to each study visit. You will also be told how to properly store the drugs.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or high by International Prostate Symptom Score (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. A single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
- •Age >/= 60 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (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.
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), 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).
- •Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
- •Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
研究组 & 干预措施
Omacetaxine and Cytarabine
Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle.
干预措施: Omacetaxine (Drug)
Omacetaxine and Cytarabine
Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle.
干预措施: Cytarabine (Drug)
结局指标
主要结局
Percentage of Participants With Complete Remission (CR)
时间窗: Up to 4 months
Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
次要结局
- Evaluation of CR Duration(Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.)
- Disease-free Survival(Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.)
- Overall Survival(Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.)
- Induction Mortality(Up to 1 year)