NCT00086203已完成2 期
Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
Point Therapeutics37 个研究点 分布在 1 个国家开始时间: 2004年6月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 37
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.
详细描述
Completion date provided represents the completion date of the grant per OOPD records
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
- •Men or women ≥18 years of age
- •Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
- •Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
- •Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
- •ECOG performance status 0, 1, or 2
- •Written informed consent
排除标准
- •Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic [with the exception of hematopoietic growth factors]). Patients must have recovered from the adverse effects of prior therapy.
- •Known primary or secondary malignancy of the central nervous system
- •Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- •Serum creatinine >2.0mg/dL (>176 micromol/L)
- •AST or ALT ≥3 x the upper limit of normal (ULN)
- •Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)
- •Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
- •Known positivity for HIV
- •Prior organ allograft
- •Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment
- •Pregnant or nursing women
研究者
研究点 (37)
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