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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


N/A
20 Years
85 Years
Not Enrolling
Both
Lymphoma, Large B-Cell, Diffuse

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Overall Survival

Outcome Time Frame:

3 year

Safety Issue:

No

Principal Investigator

Jae-Yong Kwak, MD.,PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonbuk National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

Chonbuk 011

NCT ID:

NCT01266668

Start Date:

February 2010

Completion Date:

June 2011

Related Keywords:

  • Lymphoma, Large B-Cell, Diffuse
  • Diffuse large B cell lymphoma
  • Breast
  • Rituximab
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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