NCT00413959

VELCADE,Rituximab,Cyclophosphamide and Decadron

Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Oncology Specialists, S.C. · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.

Detailed description

This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.

Conditions

• Lymphoma, Non-Hodgkin
• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	VELCADE®	1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
DRUG	Rituximab	375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
DRUG	Cyclophosphamide	400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
DRUG	Decadron	40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23

Timeline

• Start date: 2006-08-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2006-12-20
• Last updated: 2018-09-19
• Results posted: 2013-09-27

Locations

2 sites across 1 country: United States