The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)
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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 |
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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 |
- Overall Survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
- 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 |
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Primary breast DLBCL
Primary breast DLBCL was defined as that involving single extranodal organ (i.e. breast) regardless of the status of nodal disease.
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Nodal DLBCL
The disease was only limited to the lymph nodes or lymphoid organs without extranodal organ involvements.
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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 |
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.
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| Korea, Republic of | |
| Chonbuk National University Hospital | |
| Jeonju, Korea, Republic of, 561-712 | |
| 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:
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Diffuse large B cell lymphoma Breast Rituximab |
Additional relevant MeSH terms:
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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 May 19, 2013