Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase II Study of Tosedostat in Combination With Either Cytarabine or Decitabine in Newly Diagnosed AML or High-Risk MDS
研究概览
地位
条件
干预/治疗
详细说明
PRIMARY OBJECTIVES:
I. To determine the 4 month survival and complete remission (CR) rates of tosedostat in combination with either cytarabine or decitabine in untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
SECONDARY OBJECTIVES:
I. To assess safety and tolerability of tosedostat in combination with either cytarabine or decitabine.
II. To determine the treatment related mortality defined as death within the first 30 days of beginning treatment.
III. To estimate rates of disease-free survival (DFS) and the 1 year overall survival (OS).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tosedostat orally (PO) once daily (QD) on days 1-35 and cytarabine intravenously (IV) on days 1-5.
ARM II: Patients receive tosedostat PO QD on days 1-35 and decitabine IV on days 1-5.
If the patient develops a significant increase in their circulating or bone marrow blast count, the subsequent cycle may be started as early as day 21 of the current cycle. In both arms, treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or partial CR (pCR) may receive 2 additional courses of treatment.
After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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Washington
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Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- All adults >= 60 years of age with untreated AML or high-risk MDS (10-19% marrow blasts) including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics; patients may be enrolled if they received prior treatment with hydroxyurea to control blood counts or demethylating agents specifically for the purpose of treating MDS
- Adults age 18 to 59 with untreated AML or high-risk MDS and a transplant-related mortality (TRM) score of >= 9.2; previous data suggests these people would have a 25% mortality with standard therapy, making this treatment a reasonable alternative
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2
- Serum creatinine =< 2.0 mg/dL; if serum creatinine > 2.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation
- Serum bilirubin =< 1.5 × upper limit of normal (ULN) (in the absence of Gilbert's syndrome)
- Aspartate transaminase (AST)/alanine transaminase (ALT) =< 3.0 × ULN
- Alkaline phosphatase =< 2.5 × ULN
- Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
- Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
- Active uncontrolled infection
- Known infection with human immunodeficiency virus (HIV)
- Medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study
- Uncontrolled angina or myocardial infarction within 6 months; patients with recent myocardial infarction apparently due to medical causes unrelated to underlying cardiac abnormalities must have a cardiac consult, and be cleared to participate in the research by the cardiologist prior to initiation of treatment and may be enrolled at the discretion of the primary investigator (PI) and treating physician
- Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a screening echocardiogram (ECHO) or multiple gate acquisition scan (MUGA) performed within 1 month prior to study screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value)
- Diagnosed or treated for another malignancy within 1 year of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Arm I (tosedostat and cytarabine)
Patients receive tosedostat PO QD on days 1-35 and cytarabine IV on days 1-5.
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鉴于IV
其他名称:
Given PO
其他名称:
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实验性的:Arm II (tosedostat and decitabine)
Patients receive tosedostat PO QD on days 1-35 and decitabine IV on days 1-5.
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鉴于IV
其他名称:
Given PO
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of patients achieving CR
大体时间:4 months after beginning treatment
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Defined by Cheson et al.
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4 months after beginning treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2566.00
- P30CA015704 (美国 NIH 拨款/合同)
- NCI-2012-00274 (注册表标识符:CTRP (Clinical Trial Reporting Program))
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阿糖胞苷的临床试验
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Samsung Medical Center未知
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The First Affiliated Hospital with Nanjing Medical...Huai'an First People's Hospital; Yancheng First People's Hospital招聘中