NCT00036257已完成1 期
Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 10
研究概览
简要总结
The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Relapsed or refractory chronic lymphocytic leukemia.
- •Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
- •Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
- •No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
- •Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
- •Expected remaining life span > or = three months.
- •ECOG performance status 0 -
- •18 years or of legal age.
- •Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
- •Negative serum pregnancy test, if fertile female.
- •Willingness and ability to sign an informed consent document.
排除标准
- •Evidence of CNS involvement.
- •Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- •Previous therapy with Campath.
- •Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
- •Concurrent immunotherapy.
- •Concurrent use of steroids.
- •Use of an investigational medication or device within 1 month of initiating study therapy.
- •Patients who have had allogeneic bone marrow transplantation.
- •Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
- •AST or ALT > 2.5 times the upper limit of normal.
- •Any condition or any medication which may interfere with the conduct of the study.
研究者
研究点 (10)
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