NCT00286780已完成2 期
A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia
Ascenta Therapeutics1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Safety of AT-101 in combination with rituximab
研究概览
简要总结
This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
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
- •Diagnosis of CLL as defined by the NCI-working group
- •Previous treatment with standard systemic chemotherapy or immunotherapy.
- •Disease progression or relapse after treatment.
- •Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
- •ECOG performance status ≤ 2
- •Adequate liver and renal and bone marrow function
排除标准
- •Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤
- •Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- •Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
- •Active secondary malignancy or history of other malignancy within the last five years
- •Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
- •Patients who are contraindicated for treatment with rituximab
- •Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
- •T-CLL or other T-cell malignancy
研究组 & 干预措施
1
Experimental
干预措施: AT-101 (Drug)
结局指标
主要结局
Safety of AT-101 in combination with rituximab
时间窗: 5 months for each patient; 20 months entire study
次要结局
- Preliminary efficacy of AT-101 in combination with rituximab(5 months)
研究者
研究点 (1)
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