CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 676 enrolled
Drug / intervention
Bortezomib + Rituximab +1 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/NCT00312845
NCT00312845Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma

Millennium Pharmaceuticals, Inc.·interventional·Posted Apr 11, 2006·Updated Jun 25, 2012

In Brief

A Phase 3 clinical trial evaluating Bortezomib + Rituximab and Rituximab for Non-Hodgkin's Lymphoma. Completed, enrolled 676 participants across 206 sites in 32 countries.

Detailed Summary

The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Cyprus, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine, United Kingdom, United States
CollaboratorsJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2006
Enrollment StartMar 1, 2006
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.2 years ago

Interventions

Bortezomib + Rituximabdrug

VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.

Rituximabdrug

rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).