NCT01040871

Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	VELCADE	VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.
DRUG	Rituximab	Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
DRUG	Cyclophosphamide	Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
DRUG	Doxorubicin	Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
DRUG	Prednisone	Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
DRUG	Vincristine	Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2009-12-30
• Last updated: 2014-01-13
• Results posted: 2013-11-27

Locations

1 site across 1 country: Belgium