NCT00289549已完成2 期
Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Response rate after 2 cyclesof forodesine therapy.
研究概览
简要总结
Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).
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
- •Ages 18 years and older
- •Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
- •Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
- •Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
- •ECOG performance status of 0, 1, 2 or 3
- •Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
- •All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.
排除标准
- •Pregnant or nursing
- •Unable or unwilling to sign consent
- •Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
- •Active serious infections that are not controlled by antibiotics
- •ECOG performance status 4
- •Inadequate renal function: creatinine 2.0 or more unless related to the disease
- •Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
- •Known positive test for HIV
- •Patients with known hepatitis B and/or hepatitis C active infection
结局指标
主要结局
Response rate after 2 cyclesof forodesine therapy.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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