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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.
Results First Submitted: May 7, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Interventions: Drug: VELCADE®
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Decadron

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Rituximab (R) are alone or R based chemo programs are front line approach LG-NHL pts requiring therapy. Identifying programs that are effective in the elderly pts is challenging. These pts were recruited in our private practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible pts had LG-NHL requiring treatment. Mantel cell NHL pts who were'nt transplant eligible and MALToma pts who failed RT and antibiotics were allowed.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Velcade, Rituximab,Cyclophosphamide & Decadron
STARTED   12 
COMPLETED   11 
NOT COMPLETED   1 
Pt had only one cycle.                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Velcade, Rituximab,Cyclophosphamide & Decadron 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   11 
Gender 
[Units: Participants]
 
Female   4 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.   [ Time Frame: 4 years ]

2.  Secondary:   Overall Survival   [ Time Frame: 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sigrun Hallmeyer, MD Director of Research
Organization: Oncology Specialists SC
phone: 847-268-8200
e-mail: shallmeyer@oncmed.net



Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00413959     History of Changes
Other Study ID Numbers: 0606
First Submitted: December 19, 2006
First Posted: December 20, 2006
Results First Submitted: May 7, 2013
Results First Posted: September 27, 2013
Last Update Posted: November 11, 2013