VELCADE®,Rituximab,Cyclophosphamide and Decadron (VRCD Regimen) (VRCD)
|ClinicalTrials.gov Identifier: NCT00413959|
Recruitment Status : Terminated
First Posted : December 20, 2006
Results First Posted : September 27, 2013
Last Update Posted : November 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Lymphoma, B-Cell||Drug: VELCADE® Drug: Rituximab Drug: Cyclophosphamide Drug: Decadron||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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
- Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. [ Time Frame: 4 years ]Percentage of complete responders plus percentage of partial responders equals overall response rate.
- Overall Survival [ Time Frame: 4 years ]The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413959
|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|