Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.
研究概览
简要总结
This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients
详细描述
Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition, studies have shown that rituximab, a therapy that targets the immune system, has the highest efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with two promising chemotherapy agents against CLL.
Purpose: This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating the genetic and molecular components of CLL will also be performed. Some of these tests will be conducted before, during, and after treatments to assess changes resulting from the study drugs. Each patient's outcome will be assessed in relation to various aspects of their genes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 B-CLL (no mantle cell)
- •Must have active disease
- •Age >=18 yo
- •No radiation or surgery <4 weeks
排除标准
- •Any of the following comorbid conditions:
- •New York Heart Association Class III or IV heart disease
- •Recent myocardial infarction (<1 month)
- •Uncontrolled infection
- •Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur.
- •Pregnant or nursing women
- •Men or women of child bearing potential must use adequate contraception.
- •Active primary malignancy requiring treatment or limits survival to ≤2 years.
- •Any radiation therapy ≤4 weeks prior to study entry.
- •Any major surgery ≤4 weeks prior to study entry.
结局指标
主要结局
To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide.
时间窗: up to 5 years
For this evaluation, patients will be classified as complete responders if either of the following types of response are documented * CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters. * CR denotes CCR and, in bone marrow, no nodules and \<30% lymphocytes.
次要结局
- To monitor and assess toxicity of this regimen.(up to 5 years)
研究者
John Byrd
Principal Investigator
Ohio State University Comprehensive Cancer Center