Back to resultsVELCADE,Rituximab,Cyclophosphamide and Decadron (VRCD)
Primary Purpose
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VELCADE®
Rituximab
Cyclophosphamide
Decadron
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring NHL
Eligibility Criteria
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.
Sites / Locations
- Onocology Specialists, S.C
- Oncology Specialists, S.C
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Velcade, Rituximab,Cyclophosphamide & Decadron
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Percentage of complete responders plus percentage of partial responders equals overall response rate.
Secondary Outcome Measures
Overall Survival
The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Full Information
NCT ID
NCT00413959
First Posted
December 19, 2006
Last Updated
August 20, 2018
Sponsor
Oncology Specialists, S.C.
Collaborators
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00413959
Brief Title
VELCADE,Rituximab,Cyclophosphamide and Decadron
Acronym
VRCD
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
August 2006 (Actual)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oncology Specialists, S.C.
Collaborators
Millennium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
Keywords
NHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Velcade, Rituximab,Cyclophosphamide & Decadron
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VELCADE®
Other Intervention Name(s)
Bortezomib
Intervention Description
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Decadron
Other Intervention Name(s)
dexamethasone
Intervention Description
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Primary Outcome Measure Information:
Title
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Description
Percentage of complete responders plus percentage of partial responders equals overall response rate.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadi Nabhan, MD
Organizational Affiliation
Oncology Specialists, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onocology Specialists, S.C
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Oncology Specialists, S.C
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VELCADE,Rituximab,Cyclophosphamide and Decadron
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