NCT00715208

Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	rituximab
DRUG	cyclophosphamide
DRUG	doxorubicin
DRUG	VELCADE
DRUG	prednisone

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2008-07-15
• Last updated: 2013-04-29
• Results posted: 2013-04-29

Locations

43 sites across 2 countries: United States, Puerto Rico