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Therapeutic Areas: Oncology
Disease Category: Non-Hodgkin's Lymphoma

Trial Information

Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).

Patient Inclusion Criteria:
Histopathologic confirmation of one of the following CD20+ B-cell non-Hodgkin's lymphomas with a lymph node biopsy performed within 6 months of study entry and with biopsy material available for review:

• follicular lymphoma (grade 1 or 2)
• immunoplasmacytoma/immunocytoma (Waldenstrom's macroglobulinemia)
• splenic marginal zone B-cell lymphoma
• extra-nodal marginal zone lymphoma of mucosa associated lymphoid tumor (MALT) type
• nodal marginal zone B-cell lymphoma
• mantle cell lymphoma

Patient Exclusion Criteria:

• Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular lymphoma.
• Transformed disease
• Prior radiation for NHL, except for a single course of locally delimited radiation therapy with a radiation field not exceeding 2 adjacent lymph node regions.

Cathy Spears, Research Manager
St. Francis Hospital and Health Centers
1500 N Albany Street, Suite 1001
Beech Grove, IN 46107
Phone: 317-782-7819
Fax: 317-782-7828
EMail: cathy.spears@ssfhs.org

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