A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.
研究概览
简要总结
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
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
- •Age >= 18 years
- •Confirmed diagnosis of AML as proven by bone marrow biopsy
- •Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
- •ECOG performance status of 0-2
- •Recovered from toxicities of prior chemotherapy
排除标准
- •History of pancreatitis
- •Active alcohol abuse
- •Taken bexarotene in the past
- •WBC > 10,000/uL at time of enrollment
- •Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg
- •Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN, creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
- •Active participant in any other investigational treatment study for AML
- •Life expectancy of less than 1 month
- •Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation
- •Uncontrolled hyperlipidemia
- •Known history of HIV
- •Known active CNS involvement with AML
- •Women of childbearing potential or active breast feeding
研究组 & 干预措施
A
干预措施: Bexarotene (Drug)
结局指标
主要结局
Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.
时间窗: Two months after 17th patient has started treatment with Bexarotene, for up to 1 year
Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674
次要结局
- Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy(Two months after 17th patient has started treatment with Bexarotene, up to 1 year.)