A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of Patients With Objective Response
研究概览
简要总结
The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied
详细描述
PRIMARY OBJECTIVES:
I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and Rituximab in patients with recurrent B-cell NHL.
SECONDARY OBJECTIVES:
I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression.
II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab on Bcl-2 protein gene expression.
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
- •Must have recurrent B-cell NHL and measurable disease
- •No anti-lymphoma therapy within the past 4 weeks
- •Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky)
- •Absolute neutrophil count (ANC) greater than or equal to 1,000
- •Platelets greater than or equal to 75,000
- •Hemoglobin greater than or equal to 10 g/dL
- •Bilirubin less than or equal to 1.5 mg/dL
- •Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT) less than or equal to 2 times upper limit of laboratory normals
- •Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals
- •Serum creatinine less than or equal to 1.8 mg/dL
- •Must sign a consent form, and must have a life expectancy of greater than 12 weeks
- •No more than 3 prior chemotherapy regimens
- •Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy
排除标准
- •Human immunodeficiency virus (HIV) positive
- •Active infection or history of opportunistic infections
- •Pregnant women and women of childbearing age who are not practicing adequate contraception; men who are not willing to use an effective method of contraception
- •History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years)
- •Active autoimmune disease
- •Other significant medical diseases
- •Patients with chronic lymphocytic leukemia (CLL)
- •Prior exposure to G3139
结局指标
主要结局
Number of Patients With Objective Response
时间窗: 2 months following study treatment
Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
次要结局
未报告次要终点