At a glance
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Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Bortezomib, Rituximab, and 4 other interventions for Mantle Cell Lymphoma. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
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).
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
Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
1 mg administered by IV on day 3 of each cycle.
40 mg orally on days 1-4 of each cycle.