NCT00800566撤回1 期
Phase I Study of Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.
详细描述
The Study Drug:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Screening Tests:
Before you can begin taking the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will also be asked about what drugs you are currently taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will also have a bone marrow aspirate and/or biopsy. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle.
- Women who are able to have children must have a negative blood or urine pregnancy test. The blood would be drawn as part of the routine sample described above.
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
- 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
- •Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB [French-American-British Classification]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
- •Absolute neutrophil count (ANC) >= 1 x 109/L and platelet count >= 50 x 109/L.
- •Adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dL; if serum creatinine > 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin </= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) </= 2.5 x ULN; alkaline phosphatase </= 2.5 x ULN.
- •ECOG performance status <=
- •Age >/= 18 years.
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. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
- •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.
- •Known hypersensitivity to nucleoside analogues.
- •Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
研究组 & 干预措施
Oral Clofarabine
Experimental
干预措施: Oral Clofarabine (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)
时间窗: October 2009
次要结局
- To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL.(October 2010)
研究者
研究点 (1)
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