Clinical Trial: Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Wisconsin, Madison

Current Primary Outcome:

• Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). [ Time Frame: At completion of induction therapy (21 weeks) ]

  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.

• Complete Response Rate (CR) at the End of Induction Chemotherapy [ Time Frame: at 21 weeks ]
  Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.

Original Primary Outcome: CT scan [ Time Frame: every 2nd cycle ]

Current Secondary Outcome:

• 3 Year Progression Free Survival [ Time Frame: 36 months ]
  This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.
• 3 Year Overall Survival (OS) [ Time Frame: 36 months ]
  This is the percent of participants who were still alive at 3 years after study entry.

Original Secondary Outcome:

Information By: University of Wisconsin, Madison

Dates:
Date Received: December 19, 2007
Date Started: May 2005
Date Completion:
Last Updated: May 12, 2016
Last Verified: May 2016