Skip to main content
OpenTrials
Completed

NCT Number: NCT01266668

The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: 3 year

Secondary outcomes

  1. Progression-free survival

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 24, 2010
Registry last updated
Nov 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.