CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Bortezomib +5 moredrug
Likely dose
Bortezomib 1.3 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00581776
NCT00581776Phase 2Completed

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

University of Wisconsin, Madison·interventional·Posted Dec 28, 2007·Updated Dec 17, 2019

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2007
Enrollment StartMay 1, 2005
Primary CompletionNov 1, 2012
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 18.5 years ago

Interventions

Bortezomibdrug

Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.

Rituximabdrug

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).

Cyclophosphamidedrug

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

Doxorubicindrug

Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.

Vincristinedrug

1 mg administered by IV on day 3 of each cycle.

Dexamethasonedrug

40 mg orally on days 1-4 of each cycle.