Phase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL).
- To determine the toxicity profile of clofarabine in CLL.
- To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.
详细描述
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical examination. You will also be asked about what medications you are taking currently and about the level of your daily activities. Routine blood tests (about 2 tablespoons) will be done within 14 days before the start of the study to make sure that you are not at increased risk for developing side effects. You may have bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.
If you are found to be eligible, you will receive clofarabine as a 1-hour infusion into a vein once once every 2 weeks for 4 weeks. This cycle makes up one treatment course.
The drug is evaluated at different dose levels. The first three patients will start with a lower dose. Unless serious side effects occur, the next group of patients (usually groups are 3 patients, although they can be expanded to include more patients if needed) will receive a higher dose.
If you show a response and do not experience any severe side effects, you can receive up to a total of 6 courses of therapy. During each course, clofarabine is given the same way as during the first course. However, the dose of clofarabine may be lowered during later courses to decrease the risk of side effects that may have occurred in previous courses. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen.
- •Absolute neutrophil count (ANC) >= 1 x 10(9)/L and platelet count >= 50 x 10(9)/L
- •Adequate liver function (total bilirubin <= 1.5 x ULN, SGPT <= 2.5 x ULN) and renal function (serum creatine <= 1.5 x ULN).
- •ECOG performance status <= 2.
排除标准
- •Patients with NYHA >= grade 3 heart disease as assessed by history and/or physical examination
- •Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception.
- •Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy)
- •Other malignancy within 3 years except in situ carcinoma
- •Unwilling or unable to provide informed consent
- •Hypersensitivity to nucleoside analogues
- •Other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, ventricular arrhythmia, diabetes, active infection, pulmonary fibrosis, and chronic hepatitis
研究组 & 干预措施
Weekly Clofarabine
干预措施: Clofarabine (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Following each 4 week treatment cycle
次要结局
未报告次要终点