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VELCADE®,Rituximab,Cyclophosphamide and Decadron (VRCD Regimen) (VRCD)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413959
First Posted: December 20, 2006
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
December 19, 2006
December 20, 2006
May 7, 2013
September 27, 2013
November 11, 2013
August 2006
January 2011   (Final data collection date for primary outcome measure)
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.
  • The primary objective of this study is to:
  • Investigate the Overall response rate (OR) and Time to disease progression (TTP) using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma as classified by the WHO.
Complete list of historical versions of study NCT00413959 on ClinicalTrials.gov Archive Site
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%.
  • The secondary objectives of this study are to: evaluate this regimen for Overall Survival (OS)
  • Duration of response and progression-free survival (PFS).
Not Provided
Not Provided
 
VELCADE®,Rituximab,Cyclophosphamide and Decadron (VRCD Regimen)
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 and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Drug: VELCADE®
    1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
    Other Name: Bortezomib
  • 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.
    Other Name: Rituxan
  • Drug: Cyclophosphamide
    400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
    Other Name: Cytoxan
  • Drug: Decadron
    40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
    Other Name: dexamethasone
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.
Interventions:
  • Drug: VELCADE®
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Decadron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Small Lymphocytic Lymphoma
  • Follicular Cell Lymphoma (grades I and II)
  • Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant
  • Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia
  • Marginal Zone Lymphoma
  • MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.
  • Adequate bone marrow function, renal function, and hepatic function as outlined in details below.
  • ECOG performance status of 0, 1, or 2
  • Able to read, understand, and sign an IRB approved informed consent

Exclusion Criteria:

  • Known HIV positive status
  • Known CNS involvement
  • Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00413959
0606
No
Not Provided
Not Provided
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
Oncology Specialists, S.C.
Millennium Pharmaceuticals, Inc.
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, SC
Oncology Specialists, S.C.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP