A Phase II Study of Imatinib and Valproic Acid in Patients With CML
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To measure the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.
研究概览
简要总结
The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.
详细描述
The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal. Briefly, patients with CML who are taking imatinib and have been found to have a plateau in their level of the bcr-abl transcript will be eligible to participate in the study. Valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be monitored to see if the addition of valproate produced a further reduction. Patients will be monitored for efficacy and toxicity.
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
- •All patients, 18 years of age or older, with a diagnosis of CML.
- •Patients must have a life expectancy of at least 12 weeks.
- •Patients must have an ECOG performance status of 0-
- •Patients must sign an informed consent.
- •Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
- •Patients with CML in chronic phase on imatinib as first line therapy who fulfill the following criteria:
- •The patient has at least two tests for quantitative reverse transcriptase polymerase chain reaction (RT-PCR) for bcr-abl (peripheral blood or bone marrow aspirate). The results of these tests should demonstrate a relative plateau in the effect of imatinib on the detected level of the transcript (i.e. there should less than a ½ log difference between the last two values). Note: Patients will be eligible if the more recent study is greater than the previous study by any value.
- •The last two quantitative RT-PCR studies should be at least 3 months apart.
- •The patient should have received at least 9 months of imatinib since the diagnosis of CML.
- •The patient is tolerating imatinib without any grade 3 or greater toxicity.
排除标准
- •Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- •Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- •Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- •Patients who have a hypersensitivity to valproic acid, derivatives, or any component of the formulation. Patients with hepatic disease or significant impairment, or urea cycle disorders
结局指标
主要结局
To measure the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.
时间窗: 6 months
次要结局
未报告次要终点