CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 206 enrolled
Drug / intervention
Bortezomib +5 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/NCT00931918
NCT00931918Phase 2Completed
CompareCT.gov

An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

Millennium Pharmaceuticals, Inc.·interventional·Posted Jul 2, 2009·Updated Jan 11, 2017

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Rituximab, and 4 other interventions for Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL). Completed, enrolled 206 participants across 70 sites.

Detailed Summary

This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17 years ago

Interventions

Bortezomibdrug

Bortezomib IV

Rituximabdrug

Rituximab IV

Cyclophosphamidedrug

Cyclophosphamide IV

Doxorubicindrug

Doxorubicin IV solution

Vincristinedrug

Vincristine IV

Prednisonedrug

Prednisone tablet