NCT00931918

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP \[rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] with or without VELCADE®. The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups: * RCHOP * Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] Participants received treatment for up to six, 21-day cycles. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2009-07-02
• Last updated: 2017-01-11
• Results posted: 2017-01-11

Locations

70 sites across 1 country: United States