VELCADE®,Rituximab,Cyclophosphamide and Decadron (VRCD Regimen)
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. [ Time Frame: 4 years ] [ Designated as safety issue: No ]Percentage of complete responders plus percentage of partial responders equals overall response rate.
- Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
|Study Start Date:||August 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
Other Name: BortezomibDrug: 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.
Other Name: RituxanDrug: Cyclophosphamide
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Other Name: CytoxanDrug: Decadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Other Name: dexamethasone
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.
|United States, Illinois|
|Onocology Specialists, S.C|
|Niles, Illinois, United States, 60714|
|Oncology Specialists, S.C|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|