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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival
From the date of treatment until the date of disease progression or death from any cause (minimum 2 years)
No
Jae-Yong Kwak, MD, PhD
Principal Investigator
Chonbuk National University Hospital
Korea: Food and Drug Administration
Chonbuk058
NCT01448096
August 2011
December 2018
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