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临床试验/NCT01266668
NCT01266668已完成不适用

Matched Pair Analysis Comparing the Outcomes of Primary Breast and Nodal Diffuse Large B Cell Lymphoma in Patients Treated With R-CHOP; Consortium for Improving Survival of Lymphoma (CISL) Study

Chonbuk National University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL using a matched pair analysis following strict matching criteria in patients with primary breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen.

详细描述

Primary breast lymphoma represents 1.7% to 2.2% of all extranodal non-Hodgkin's lymphoma. Histologically, the diffuse large B cell lymphoma (DLBCL) is the most predominant subtype of PBL. Previous studies in the pre-rituximab era have identified the worse outcomes in primary breast DLBCL compared with nodal DLBCL. Few clinical studies have been reported for investigating the efficacy of rituximab in patients with primary breast DLBCL. For clarifying this, a large randomized trial comparing survival in patients with primary breast DLBCL is required. However, the rarity of primary breast DLBCL makes large trial virtually difficult in single center or study group. Additionally, retrospective studies for evaluating the role of rituximab in primary breast DLBCL had bias according to the difference of treatment period between CHOP and R-CHOP era. Thus, in attempt to clarify the impact of rituximab on survival and patterns of progression in patients with primary breast DLBCL, the investigators performed this matched pair analysis following strict matching criteria in patients with primary breast DLBCL, who were identified from our previous nation-wide survey, and nodal DLBCL, who were selected from the data registry of Korean Society of Hematology Lymphoma Working Party, treated with R-CHOP regimen.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage I or II of primary breast DLBCL treated with R-CHOP
  • Stage I or II of nodal DLBCL treated with R-CHOP
  • Definition of primary breast DLBCL - Isolated breast involvement with or without nodal disease, which include distant nodal disease as well as regional nodal disease
  • Definition of nodal DLBCL
  • The disease was only limited to the lymph nodes or lymphoid organs

排除标准

  • Primary breast DLBCL or nodal DLBCL treated without rituximab
  • Secondary breast DLBCL
  • Recurrent DLBCL
  • Stage III or IV of nodal DLBCL with extranodal involvement as a dissemination process

结局指标

主要结局

Overall Survival

时间窗: 3 year

次要结局

  • Progression-free survival(3 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho-Young Yhim

Clinical professor

Chonbuk National University Hospital

研究点 (1)

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