Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 22
- 主要终点
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
研究概览
简要总结
The purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.
详细描述
Upon determination of eligibility, patients will randomly be assigned to one of two treatment arms:
- Rituximab
- Rituximab + bevacizumab
For every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1 patient will receive treatment number 2 (rituximab + bevacizumab). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •To be included in the study, you must meet the following criteria:
- •Follicular NHL, grades 1 or 2 confirmed by a biopsy sample
- •18 years of age or older
- •Evidence of disease progression at time of study entry
- •Must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens.
- •Patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy.
- •Measurable or evaluable disease
- •Able to perform activities of daily living without considerable assistance
- •Adequate bone marrow, kidney, and liver function
- •Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
排除标准
- •You cannot participate in the study if any of the following apply to you:
- •Treatment with more than two previous chemotherapy regimens
- •Prior treatment with bevacizumab or other similar agents
- •Progressive NHL less than 6 months after receiving previous rituximab
- •More than 1 prior treatment with investigational agents within 4 weeks prior to entering this study
- •Spread of NHL to brain or nervous system
- •History of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
研究组 & 干预措施
Rituximab
All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
干预措施: Rituximab (Drug)
Rituximab/Bevacizumab
All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
干预措施: Bevacizumab (Drug)
Rituximab/Bevacizumab
All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
时间窗: 18 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Progression Free Survival (PFS)(18 months)