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

This study has been completed.

Sponsor:

Collaborator:

Millennium Pharmaceuticals, Inc.

Information provided by (Responsible Party):

Dr. Chadi Nabhan, Oncology Specialists, S.C.

ClinicalTrials.gov Identifier:

NCT00413959

First received: December 19, 2006

Last updated: December 7, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2006

Last Updated Date

December 7, 2012

Start Date ^ICMJE

August 2006

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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:

Change History

Complete list of historical versions of study NCT00413959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary objectives of this study are to: evaluate this regimen for Overall Survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Duration of response and progression-free survival (PFS). [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

The secondary objectives of this study are to: evaluate this regimen for Overall Survival (OS)
Duration of response and progression-free survival (PFS).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00413959

Other Study ID Numbers ^ICMJE

0606

Has Data Monitoring Committee

Responsible Party

Dr. Chadi Nabhan, Oncology Specialists, S.C.

Study Sponsor ^ICMJE

Oncology Specialists, S.C.

Collaborators ^ICMJE

Millennium Pharmaceuticals, Inc.

Investigators ^ICMJE

Principal Investigator:

Chadi Nabhan, MD

Oncology Specialists, SC

Information Provided By

Oncology Specialists, S.C.

Verification Date

December 2012

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

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