Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Mantle Cell Lymphoma
Intervention	Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone
Phase	Phase 2
Sponsor	University of Wisconsin, Madison
Responsible Party	University of Wisconsin, Madison
ClinicalTrials.gov Identifier	NCT00581776
First Received	December 19, 2007
Last Updated	March 18, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 19, 2007
Last Updated Date	March 18, 2014
Start Date	May 2005
Estimated Primary Completion Date	November 2014
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	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.

Descriptive Information[ + expand ][ + ]

Brief Title	Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
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 Description	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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Mantle Cell Lymphoma
Intervention	Drug: Bortezomib Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle. Other Names: 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 Names: 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 Names: 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.
Study Arm (s)	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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	30
Estimated Completion Date	November 2014
Estimated Primary Completion Date	November 2008
Eligibility Criteria	Inclusion Criteria: - Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy. Exclusion Criteria: - Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00581776
Other Study ID Numbers	HO05401
Has Data Monitoring Committee	Yes
Information Provided By	University of Wisconsin, Madison
Study Sponsor	University of Wisconsin, Madison
Collaborators	Not Provided
Investigators	Principal Investigator: Brad S Kahl, MD University of Wisconsin, Madison
Verification Date	March 2014

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