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

NCT01266668 | Completed

• 1 other identifier: Chonbuk 011
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Diffuse large B cell lymphoma; Breast; Rituximab

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  3 year

Secondary Outcomes (1)

• Progression-free survival

  3 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Related Publications (1)

• 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.

  PMID: 21823120 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jae-Yong Kwak, MD.,PhD.

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 24, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

KR (1)