Thalidomide Maintenance Treatment in DLBCL
2017年7月26日 更新者：Ru Feng、Nanfang Hospital of Southern Medical University
A Multicentre, Randomized Phase III Study of Thalidomide Maintenance Treatment in Patients With Diffuse Large B-cell Lymphoma
This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).
研究概览
详细说明
This is a randomized, phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival(RFS), in diffuse large B cell lymphoma(DLBCL).Patients will be enrolled after successful standard induction therapy (CR or CRu following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles).
Patients will be followed until an event occurs as defined in the protocol.
To evaluate the clinical efficacy of thalidomide maintenance therapy as compared to observation in patients with DLBCL who have achieved a complete remission after appropriate first-line therapy, measured by RFS, 226 patients with DLCBL will be recruited.
研究类型
介入性
注册 (预期的)
226
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xiaolei Wei, Ph.D.
- 电话号码：86-20-61641613
- 邮箱：smuxiaoleiwei@163.com
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510515
- 招聘中
- Ru Feng
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接触：
- Ru Feng, M.D.
- 电话号码：+86 13725119762
- 邮箱：ruth1626@hotmail.com
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首席研究员：
- Ru Feng, M.D.
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接触：
- Qi Wei, M.D.
- 电话号码：+86 13427564102
- 邮箱：sinbad37@126.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- NCCN-IPI>1,
- Known IPI, cell of origin and DHL at time of diagnosis,
- Negative pregnancy test,
- Men must agree not to father a child during the therapy,
- 6 to 8 cycles R-CHOP/like, total of 8 x Rituximab,
- CR, CRu
Exclusion Criteria:
- Transformed lymphoma,
- Secondary malignancy,
- HIV positive,
- Evidence of CNS involvement,
- Cardiac dysfunction (systolic ejection fraction <50%),
- Creatinine > 2.0 mg/dl
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：观察
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只是观察
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实验性的：Thalidomide
Thalidomide 50mg daily by mouth( increase 50mg after 2 weeks if tolerated until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if the patient experienced grade 2 or higher AEs.
Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/day, thalidomide discontinuation was allowed.
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Thalidomide 50mg daily by mouth( increase 25mg after 2 weeks if tolerated Until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if patient experienced grade 2 or higher AEs.
Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/ day, thalidomide discontinuation was allowed.
其他名称：
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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 |
|---|---|---|
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Relapse-free survival
大体时间：5 years
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RFS was defined as the time between randomization and any documentation of relapse, death by any cause or last follow up.
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5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival
大体时间：5 years
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OS was defined as the interval from randomization to death or the last follow-up for surviving patients.
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5 years
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Incidence of treatment-emergent adverse events
大体时间：5 years
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Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT).
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5 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ru Feng, M.D.、Department of Hematology, Nanfang Hospital, Southern Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Spencer A, Prince HM, Roberts AW, Prosser IW, Bradstock KF, Coyle L, Gill DS, Horvath N, Reynolds J, Kennedy N. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009 Apr 10;27(11):1788-93. doi: 10.1200/JCO.2008.18.8573. Epub 2009 Mar 9.
- Chaganti S, Illidge T, Barrington S, Mckay P, Linton K, Cwynarski K, McMillan A, Davies A, Stern S, Peggs K; British Committee for Standards in Haematology. Guidelines for the management of diffuse large B-cell lymphoma. Br J Haematol. 2016 Jul;174(1):43-56. doi: 10.1111/bjh.14136. Epub 2016 May 16. No abstract available.
- Michallet AS, Lebras L, Coiffier B. Maintenance therapy in diffuse large B-cell lymphoma. Curr Opin Oncol. 2012 Sep;24(5):461-5. doi: 10.1097/CCO.0b013e3283562036.
- Aviles A, Cleto S, Huerta-Guzman J, Neri N. Interferon alfa 2b as maintenance therapy in poor risk diffuse large B-cell lymphoma in complete remission after intensive CHOP-BLEO regimens. Eur J Haematol. 2001 Feb;66(2):94-9. doi: 10.1034/j.1600-0609.2001.00272.x.
- Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N, Shpilberg O, Duhrsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Briere J, Salles G, Moskowitz CH, Glass B. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol. 2012 Dec 20;30(36):4462-9. doi: 10.1200/JCO.2012.41.9416. Epub 2012 Oct 22.
- Crump M, Leppa S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23.
- Witzens-Harig M, Benner A, McClanahan F, Klemmer J, Brandt J, Brants E, Rieger M, Meissner J, Hensel M, Neben K, Dreger P, Lengfelder E, Schmidt-Wolf I, Kramer A, Ho AD. Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma. Results of the HD2002 prospective multicentre randomized phase III trial. Br J Haematol. 2015 Dec;171(5):710-9. doi: 10.1111/bjh.13652. Epub 2015 Oct 9.
- Ji D, Li Q, Cao J, Guo Y, Lv F, Liu X, Wang B, Wang L, Luo Z, Chang J, Wu X, Hong X. Thalidomide enhanced the efficacy of CHOP chemotherapy in the treatment of diffuse large B cell lymphoma: A phase II study. Oncotarget. 2016 May 31;7(22):33331-9. doi: 10.18632/oncotarget.8973.
- Maiolino A, Hungria VT, Garnica M, Oliveira-Duarte G, Oliveira LC, Mercante DR, Miranda EC, Quero AA, Peres AL, Barros JC, Tanaka P, Magalhaes RP, Rego EM, Lorand-Metze I, Lima CS, Renault IZ, Braggio E, Chiattone C, Nucci M, de Souza CA; Brazilian Multiple Myeloma Study Group (BMMSG/GEMOH). Thalidomide plus dexamethasone as a maintenance therapy after autologous hematopoietic stem cell transplantation improves progression-free survival in multiple myeloma. Am J Hematol. 2012 Oct;87(10):948-52. doi: 10.1002/ajh.23274. Epub 2012 Jun 23.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月26日
初级完成 (预期的)
2019年12月1日
研究完成 (预期的)
2023年12月1日
研究注册日期
首次提交
2016年11月2日
首先提交符合 QC 标准的
2017年1月7日
首次发布 (估计)
2017年1月10日
研究记录更新
最后更新发布 (实际的)
2017年7月28日
上次提交的符合 QC 标准的更新
2017年7月26日
最后验证
2017年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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