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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

NCT00931918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2017-01-11

Study results available
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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.

Conditions

  • Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

DRUG

Bortezomib

Bortezomib IV

DRUG

Rituximab

Rituximab IV

DRUG

Cyclophosphamide

Cyclophosphamide IV

DRUG

Doxorubicin

Doxorubicin IV solution

DRUG

Vincristine

Vincristine IV

DRUG

Prednisone

Prednisone tablet

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931918 on ClinicalTrials.gov