A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.
研究概览
简要总结
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.
This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.
详细描述
This is a multicenter, prospective study.
- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Treatment repeats every 35 days for 3 courses. Patients achieving a complete response, partial response, or stable disease proceed to maintenance therapy.
- Maintenance therapy: Beginning 6-8 weeks after induction therapy, patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1. Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected at baseline and periodically during study treatment.
After completion of study therapy, patients are followed every 3 months for 2 years.
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
- •Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma
- •Life expectancy > 12 months
排除标准
- •No known history of HIV infection
- •No other active infection
- •No peripheral neuropathy ≥ grade 2 within the past 14 days
- •No uncontrolled hypertension
- •None of the following cardiac conditions:
- •Myocardial infarction within the past 6 months
- •No heart failure
- •Uncontrolled angina
- •Severe uncontrolled ventricular arrhythmias
- •Electrocardiographic evidence of acute ischemia
- •Active conduction system abnormalities
- •No serious medical or psychiatric illness that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior therapy for non-Hodgkins lymphoma
- •No prior bortezomib or rituximab
- •At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy
- •At least 2 weeks since prior investigational drugs
- •No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia
研究组 & 干预措施
Bortezomib and Rituximab
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
干预措施: Rituximab (Drug)
Bortezomib and Rituximab
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
干预措施: bortezomib (Drug)
结局指标
主要结局
Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.
时间窗: At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.
The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL. Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definitely assignable to NHL. There must also be complete disappearance of lymphoma involvement in the bone marrow (if initially present). Partial response (PR) requires 50% decrease in SPD of the six largest dominant nodes or nodal masses and no increase in the size of the other nodes, liver, or spleen.
次要结局
- Overall Response Rate After 1 Course of Induction Therapy(At baseline and at the completion of cycle 1 (1 cycle =35 days))
- Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment(Day 1 of each cycle and at the completion of cycles 1 and 3, during treatment up to 12 months)
- Overall Response Rate After Completion of Maintenance Therapy(At baseline and every 2 months during treatment of up to 3 cycles of induction (1 cycle =35days) and 4 cycles of maintenance (1 cycle =2 months) for up to 12 months.)
- Duration of Overall Response(Every 2 months for up to 12 months then every 6 months for 2 years and annually for 1 year)
- Correlation of Tumor Burden(At the start of treatment and at Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS and OS for all patients is reported at 4 years.)
- Tissue Evaluation(At baseline and at response assessment 1 after induction part A, 2, after induction part B and 3, maintenance period.)
- Percentage of Patients With Treatment Failure(Median follow up for all patients was 50 months and on intent to treat, TTF rate for all patients is reported at 4 years.)
- Progression Free Survival (PFS) Rate(Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS for all patients is reported at 4 years.)