Combination Chemotherapy With or Without Bortezomib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma
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.
研究概览
详细说明
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.
OUTLINE: This is a randomized, open-label, parallel group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (CHOP): Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Arm I has been discontinued April 2012 on recommendation of the DMC.
- Arm II (CHOP with bortezomib): 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.
In both arms, 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.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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England
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Basingstoke、England、英国、RG24 9NA
- Basingstoke and North Hampshire NHS Foundation Trust
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Birmingham、England、英国、B9 5SS
- Birmingham Heartlands Hospital
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Birmingham、England、英国、B75 7RR
- Good Hope Hospital
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Blackpool、England、英国、FY3 8NR
- Blackpool Victoria Hospital
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Cambridge、England、英国、CB2 2QQ
- Addenbrooke's Hospital
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Dartford、England、英国、DA2 8DA
- Darent Valley Hospital
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Harrogate、England、英国、HG2 7SX
- Harrogate District Hospital
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Leeds、England、英国、LS1 3EX
- Leeds General Infirmary
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Liverpool、England、英国、L7 8XP
- Royal Liverpool University Hospital
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London、England、英国、SE1 9RT
- Guy's Hospital
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Maidstone、England、英国、ME16 9QQ
- Mid Kent Oncology Centre at Maidstone Hospital
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Newcastle-Upon-Tyne、England、英国、NE1 4LP
- Royal Victoria Infirmary
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Norfolk、England、英国、NR31 6LA
- James Paget Hospital
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Norwich、England、英国、NR4 7UY
- Norfolk and Norwich University Hospital
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Plymouth、England、英国、PL6 8DH
- Derriford Hospital
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Prescot Merseyside、England、英国、L35 5DR
- Whiston Hospital
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Southampton、England、英国、SO16 6YD
- Southampton General Hospital
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Sunderland、England、英国、SR4 7TP
- Sunderland Royal Hospital
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Taunton、England、英国、TA1 5DA
- Musgrove Park Hospital
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Torquay、England、英国、TQ2 7AA
- Torbay Hospital
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Truro, Cornwall、England、英国、TR1 3LJ
- Royal Cornwall Hospital
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Scotland
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Aberdeen、Scotland、英国、AB25 2ZN
- Aberdeen Royal Infirmary
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Inverness、Scotland、英国、1V2 3UJ
- Raigmore Hospital
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Wales
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Bangor、Wales、英国、LL57 2PW
- Ysbyty Gwynedd
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Llanelli、Wales、英国、SA14 8QF
- Prince Philip Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Diagnosis of mantle cell lymphoma (MCL)
- Expression of cyclin D1 or evidence of t(11;14) translocation by cytogenetics, FISH, or polymerase chain reaction
- Refractory to or relapsed or progressed after first line antineoplastic therapy
- Measurable disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
- ANC ≥ 1,000/mm³ (not related to lymphoma)
- Platelet count ≥ 30,000/mm³
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Total bilirubin ≤ 2 times ULN
- Creatinine clearance ≥ 20 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Exclusion criteria:
- Known serological positivity for HBV, HCV, or HIV
- History of allergic reaction attributable to compounds containing boron or mannitol
- Diagnosed or treated for a malignancy other than MCL within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or any in situ malignancy
- Active systemic infection requiring treatment
- Serious medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- Toxic effects of prior therapy or surgery must be resolved to ≤ grade 2
- Prior splenectomy or localized radiotherapy allowed
Any prior chemotherapy regimen allowed
- Chemotherapy may have been given in combination with rituximab
- Concurrent enrollment in a nontreatment study allowed, provided it does not interfere with participation in this study
Exclusion criteria:
- Prior bortezomib
- Antineoplastic therapy within the past 3 weeks
- Nitrosoureas within the past 6 weeks
- Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody within the past 4 weeks
- Radiotherapy within the past 3 weeks
- Major surgery within the past 2 weeks
- Concurrent investigational agents
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Disease progression
大体时间：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.
|
30 days and every 12 weeks
|
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Unacceptable toxicity or tolerability as assessed by NCI CTCAE v3.0
大体时间：continual after first drug dose
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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.
|
continual after first drug dose
|
合作者和调查者
调查人员
- 学习椅：Simon Rule, MD、Derriford Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CDR0000559820
- NCRN-Ply-26s
- EU-20747
- ISRCTN200600609024
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