Idarubicin, Cytarabine and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With Good Complete Remission (CR)
研究概览
简要总结
This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To assess the rate of achieving a "good complete response (CR)" after treating patients with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and pravastatin (pravastatin sodium) (IAP).
II. To determine the toxicity (death within 28 days of starting therapy = treatment related mortality or "TRM") with IAP in newly-diagnosed AML.
SECONDARY OBJECTIVES:
I. To determine rates of complete remission (CR), remission with incomplete blood count recovery (CRi), partial remission (PR), relapse-free survival and overall survival.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria, including patients with >= 20% blasts in the bone marrow or peripheral blood (except acute promyelocytic leukemia), or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by WHO 2008 classification
- •Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score of =< 9.2
- •Bilirubin < 2.0 mg/ml
- •Any creatinine value is acceptable
- •Any performance status is eligible
- •Life expectancy otherwise > 1 year
- •Patients are not excluded based on cardiac history
- •Females of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- •Patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
排除标准
- 未提供
研究组 & 干预措施
Treatment (pravastatin sodium, idarubicin, and cytarabine)
Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pravastatin sodium (Drug)
Treatment (pravastatin sodium, idarubicin, and cytarabine)
Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: idarubicin (Drug)
Treatment (pravastatin sodium, idarubicin, and cytarabine)
Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: cytarabine (Drug)
Treatment (pravastatin sodium, idarubicin, and cytarabine)
Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Number of Participants With Good Complete Remission (CR)
时间窗: 35 days
A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used. Definition of Good CR: Conventional criteria for CR (absolute neutrophil count \> 1,000/uL, platelet count \> 100,000/uL, marrow with \<5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained.
Number of Participants With TRM.
时间窗: 28 days
A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used. TRM: Treatment Related Mortality
次要结局
- Progression Free Survival (PFS)(1 year after treatment with IAP)
- Overall Survival(1 year after treatment with IAP)
- Number of Biomarker-positive Participants With Clinical Responses(38 days after dosing)
- Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)(35 days)
研究者
Mazyar Shadman
Principal Investigator
Fred Hutchinson Cancer Center