Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
This trial is active, not recruiting.
|Condition||mantle cell lymphoma|
|Treatments||bortezomib, rituximab, cyclophosphamide, doxorubicin, vincristine, dexamethasone|
|Sponsor||University of Wisconsin, Madison|
|Start date||May 2005|
|End date||November 2008|
|Trial size||30 participants|
|Trial identifier||NCT00581776, HO05401|
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|
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)
Complete Response Rate (CR) at the End of Induction Chemotherapy
time frame: at 21 weeks
3 Year Progression Free Survival
time frame: 36 months
3 Year Overall Survival (OS)
time frame: 36 months
Male or female participants at least 18 years old.
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.
|Official title||Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma|
|Principal investigator||Brad S Kahl, MD|
|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.|
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