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

This study has been terminated.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00413959
First received: December 19, 2006
Last updated: October 17, 2013
Last verified: October 2013

December 19, 2006
October 17, 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 ] [ Designated as safety issue: No ]
Percentage of complete responders plus percentage of partial responders equals overall response rate.
  • 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.
  • The primary objective of this study is to:
Complete list of historical versions of study NCT00413959 on ClinicalTrials.gov Archive Site
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%.
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00413959
0606
No
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