CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
bortezomib +8 moredrug
Likely dose
Not stated in 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/NCT00433537
NCT00433537Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Feb 12, 2007·Updated Oct 30, 2014

In Brief

A Phase 2 clinical trial evaluating bortezomib, rituximab, and 7 other interventions for Contiguous Stage II Mantle Cell Lymphoma and 4 related conditions. Completed, enrolled 77 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib works in treating patients with untreated mantle cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Treatment consists of six agents: bortezomib (Vc), rituximab (R), cyclophosphamide (C), vincristine (V), doxorubicin (A), and dexamethasone (D) (VcR-CVAD).

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2007
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 19.4 years ago

Interventions

bortezomibdrug

Given IV

rituximabbiological

Given IV

cyclophosphamidedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

vincristinedrug

Given IV

dexamethasonedrug

Given IV

filgrastimbiological

Given SC

pegfilgrastimbiological

Given SC

Autologous stem cell transplantation (ASCT)procedure