Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
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.
Mantle Cell Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma|
- 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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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.
- 3 Year Progression Free Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]This is the percent of participants who were still alive at 3 years after study entry.
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: VCR-CVAD with rituximab maintenance
Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years.
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
Other Name: Velcade, PS-341Drug: Rituximab
Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
Other Name: RituxanDrug: Cyclophosphamide
Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
Other Name: cytoxanDrug: Doxorubicin
Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.Drug: Vincristine
1 mg administered by IV on day 3 of each cycle.Drug: Dexamethasone
40 mg orally on days 1-4 of each cycle.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581776
|United States, Wisconsin|
|University Of Wisconsin Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Brad S Kahl, MD||University of Wisconsin, Madison|