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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ho-Young Yhim, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01266668
First received: December 21, 2010
Last updated: November 28, 2011
Last verified: November 2011

December 21, 2010
November 28, 2011
February 2010
May 2011   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01266668 on ClinicalTrials.gov Archive Site
Progression-free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

The primary breast DLBCL group was identified from the nation-wide surveys in the university hospital, general hospital, and cancer institute of Korea. And, the nodal DLBCL group, as a matching control group, was selected from the data registry of Korean Society of Hematology Lymphoma Working Party.

Lymphoma, Large B-Cell, Diffuse
Not Provided
  • Primary breast DLBCL
    Primary breast DLBCL was defined as that involving single extranodal organ (i.e. breast) regardless of the status of nodal disease.
  • Nodal DLBCL
    The disease was only limited to the lymph nodes or lymphoid organs without extranodal organ involvements.
Yhim HY, Kim JS, Kang HJ, Kim SJ, Kim WS, Choi CW, Eom HS, Kim JA, Lee JH, Won JH, Shim H, Huh J, Lee DH, Suh C, Kwak JY. Matched-pair analysis comparing the outcomes of primary breast and nodal diffuse large B-cell lymphoma in patients treated with rituximab plus chemotherapy. Int J Cancer. 2012 Jul 1;131(1):235-43. doi: 10.1002/ijc.26352. Epub 2011 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01266668
Chonbuk 011
No
Ho-Young Yhim, Chonbuk National University Hospital
Chonbuk National University Hospital
Not Provided
Principal Investigator: Jae-Yong Kwak, MD.,PhD. Chonbuk National University Hospital
Chonbuk National University Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP