Large B Cell Diffuse Lymphoma Clinical Trial
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
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|