NCT00046488已完成1 期
A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
研究概览
简要总结
To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Signed IRB-approved informed consent.
- •Greater than 18 years of age
- •Proof of CD23+ CLL or small lymphocytic lymphoma (SLL)
- •Progressive disease after at least 1 course of chemotherapy
- •Acceptable hematologic status, liver function, renal function, and pulmonary function
- •Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
排除标准
- •Previous exposure to IDEC-152 or other anti-CD23 antibodies
- •Presence of HIV infection or AIDS
- •Serious nonmalignant disease
- •Active uncontrolled bacterial, viral or fungal infections.
- •Clinically active autoimmune disease
- •Pregnant or currently breast feeding
结局指标
主要结局
Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
时间窗: 48 months
Characterize the safety profile of IDEC-152
时间窗: 48 months
次要结局
- Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL(48 months)
- Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL(48 months)
研究者
研究点 (6)
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