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
  Purpose

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.


Condition
Lymphoma, Large B-Cell, Diffuse

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official 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

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266668

Locations
Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Jae-Yong Kwak, MD.,PhD. Chonbuk National University Hospital
  More Information

No publications provided by Chonbuk National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ho-Young Yhim, Clinical professor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01266668     History of Changes
Other Study ID Numbers: Chonbuk 011
Study First Received: December 21, 2010
Last Updated: November 28, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Diffuse large B cell lymphoma
Breast
Rituximab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 20, 2014