Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
Primary objective is to estimate the overall response rate (ORR) and the complete response
rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients
will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine,
Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x
4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).
Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses.
At completion of induction therapy (21 weeks)
Brad S Kahl, MD
University of Wisconsin, Madison
United States: Institutional Review Board
|University of Wisconsin Cancer Center||Madison, Wisconsin 53792|