Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
The purpose of this study is to clarify the impact of rituximab on clinical outcomes in patients with primary breast diffuse large B-cell lymphoma and also to investigate the role of prophylactic intrathecal chemotherapy using methotrexate for reducing central nervous system (CNS) recurrence.
Large B Cell Diffuse Lymphoma
Procedure: Prophylactic intrathecal chemotherapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-center Phase II Study of the Combination of R-CHOP (RItuximab Plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) and Prophylactic Intrathecal Chemotherapy With Methotrexate in Patients With CD20+ Primary Breast Diffuse Large B-cell Lymphoma|
- progression-free survival [ Time Frame: From the date of treatment until the date of disease progression or death from any cause (minimum 2 years) ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: From the date of treatment until the date of death from any cause (minimum 2 years) ] [ Designated as safety issue: No ]
- Number of patients with CNS recurrence [ Time Frame: From the date of treatment until the date of CNS recurrrence (minimum 2 years) ] [ Designated as safety issue: No ]
- Number of patients with adverse events [ Time Frame: From the first date of treatment until 30 days after the last treatment ] [ Designated as safety issue: Yes ]safety of a combined treatment of R-CHOP21 and prophylactic intrathecal chemotherapy according to the NCI-CTCAE ver.3.0
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: primary breast DLBCL
isolated breast involvement with or without nodal disease
R-CHOP21 consist of rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), and vincristine (1.4 mg/m2, a maximum of 2mg), administered intravenously on day 1 and 100 mg oral prednisone on days 1 through 5.Procedure: Prophylactic intrathecal chemotherapy
Prophylactic intrathecal chemotherapy using methotrexate (12mg total dose) will be performed
Primary breast diffuse large B-cell lymphoma (DLBCL) is a rare presentation of non-Hodgkin's lymphoma. A significant risk of contralateral breast involvement and a tendency for central nervous system (CNS) progression have been identified in previous studies. Optimal treatment strategies for primary breast DLBCL have remained undefined, although the combination of anthracycline-based chemotherapy and radiotherapy may be considered to be the best treatment option in these studies. However, despite the administration of aggressive treatment, prognosis is still poor, even in localized disease, with 5-year progression-free survival rates of approximately 50% to 65% in most series. Therefore, other therapeutic options must be explored.
During the last decade, several studies have shown that rituximab plus CHOP or CHOP-like chemotherapy significantly improves clinical outcomes of patients with DLBCL. However, the relevance of rituximab in the management of this rare extranodal lymphoma has never been studied. Moreover, several studies have also suggested the possibility that prophylactic intrathecal chemotherapy might be effective in reducing CNS recurrence.
Thus, this trial is designed to prospectively evaluate the treatment strategy, which addressed the safety and efficacy of a combined therapy that included R-CHOP21 and prophylactic intrathecal chemotherapy using methotrexate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448096
|Contact: Ho-Young Yhim, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Chonbuk National University Hospital||Recruiting|
|Jeonju, Korea, Republic of, 561-712|
|Contact: Ho-Young Yhim, MD 82-63-250-1791 email@example.com|
|Principal Investigator: Jae-Yong Kwak, MD, PhD|
|Principal Investigator:||Jae-Yong Kwak, MD, PhD||Chonbuk National University Hospital|