VELCADE,Rituximab,Cyclophosphamide and Decadron

Study Overview
=================
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.

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

Conditions
-----------------
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Drug: VELCADE®
* Drug: Rituximab
* Drug: Cyclophosphamide
* Drug: Decadron


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Velcade, Rituximab,Cyclophosphamide & Decadron<br>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. | Drug: VELCADE®<br>* 1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.<br>* Other names: Bortezomib;Drug: Rituximab<br>* 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.<br>* Other names: Rituxan;Drug: Cyclophosphamide<br>* 400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.<br>* Other names: Cytoxan;Drug: Decadron<br>* 40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23<br>* Other names: dexamethasone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NHL