VELCADE®,Rituximab,Cyclophosphamide and Decadron (VRCD Regimen) (VRCD)
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|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: Bortezomib
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: Rituxan
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Other Name: Cytoxan
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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|