CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
rituximab +5 morebiological
Likely dose
rituximab 375 mgfrom 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/NCT00376961
NCT00376961Phase 2Completed

A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma

SWOG Cancer Research Network·interventional·Posted Sep 15, 2006·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating rituximab, bortezomib, and 4 other interventions for Lymphoma. Completed, enrolled 68 participants across 147 sites.

Detailed Summary

RATIONALE: 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by 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. Giving bortezomib as maintenance therapy may keep the cancer from progressing. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2012
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.8 years ago

Interventions

rituximabbiological

375 mg/m\^2 on day 1 for cycles 1-6.

bortezomibdrug

1.3 mg/m\^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.

cyclophosphamidedrug

750 mg/m\^2 on day 1 of cycles 1-6.

doxorubicin hydrochloridedrug

50 mg/m\^2 on day 1 of cycles 1-6.

prednisonedrug

100 mg on days 1-5 of cycles 1-6.

vincristine sulfatedrug

1.4 mg/m\^2 on day 1 of cycles 1-6.