CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
rituximab +4 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/NCT00715208
NCT00715208Phase 2Completed

A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.

Millennium Pharmaceuticals, Inc.·interventional·Posted Jul 15, 2008·Updated Apr 29, 2013

In Brief

A Phase 2 clinical trial evaluating rituximab, cyclophosphamide, and 3 other interventions for Relapsed Follicular Lymphoma. Completed, enrolled 55 participants across 43 sites in 2 countries.

Detailed Summary

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2008
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.0 years ago

Interventions

rituximabdrug

cyclophosphamidedrug

doxorubicindrug

VELCADEdrug

prednisonedrug