A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 25
- 主要终点
- Disease progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bortezomib may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without bortezomib in treating mantle cell lymphoma.
PURPOSE: This randomized phase II trial is studying combination chemotherapy and bortezomib to see how well they work compared with combination chemotherapy alone in treating patients with relapsed or refractory mantle cell lymphoma. Combination chemotherapy alone (Arm I) has been discontinued April 2012 on recommendation of the DMC.
详细描述
OBJECTIVES:
Primary
- To evaluate the rates of overall response (complete response [CR], CR unconfirmed [CRu], and partial response).
Secondary
- To evaluate the rates of CR and CRu.
- To determine the median time to progression.
- To determine the median overall survival.
- To evaluate the toxicity and tolerability.
- To compare the responses to these treatment regimens with those from first line therapy.
- To compare the quality of life.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: bortezomib (Drug)
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: cyclophosphamide (Drug)
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: doxorubicin hydrochloride (Drug)
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: prednisolone (Drug)
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: vincristine sulfate (Drug)
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: questionnaire administration (Other)
Bortezomib plus CHOP
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1; and oral prednisolone on days 1-5.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Disease progression
时间窗: 30 days and every 12 weeks
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
Unacceptable toxicity or tolerability as assessed by NCI CTCAE v3.0
时间窗: continual after first drug dose
The follow-up visits will be at 30 days after last dose of study drug and after that every 12 weeks until: Progressive disease, initiation of further anti-neoplastic therapy, patient decision to withdraw from the study, patient death.
次要结局
未报告次要终点