A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 146
- 主要终点
- 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
研究概览
简要总结
RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the 2-year progression-free survival rate in patients with newly diagnosed mantle cell lymphoma treated with induction therapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and bortezomib followed by bortezomib maintenance (VM) therapy.
Secondary
- Determine the response rate (complete, complete unconfirmed, and partial responses) in patients treated with this regimen.
- Determine the toxicity of VM in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
R-CHOP + Velcade
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
干预措施: rituximab (Biological)
R-CHOP + Velcade
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
干预措施: bortezomib (Drug)
R-CHOP + Velcade
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
干预措施: cyclophosphamide (Drug)
R-CHOP + Velcade
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
干预措施: doxorubicin hydrochloride (Drug)
R-CHOP + Velcade
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
干预措施: prednisone (Drug)
R-CHOP + Velcade
6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
时间窗: 0-2 years
Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.
次要结局
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.)
- Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).(At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment)
- 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)(0-2 years)