VELCADE,Rituximab,Cyclophosphamide and Decadron

Lymphoma, Non-Hodgkin Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00413959
• Other study ID #: 0606
• Status: Terminated
• Phase: Phase 2
• Start date: August 2006
• Est. completion date: January 2011

Study information

• Verified date: August 2018
• Source: Oncology Specialists, S.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• VELCADE®
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
• 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.
• Cyclophosphamide
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
• Decadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23

Locations

Country	Name	City	State
United States	Onocology Specialists, S.C	Niles	Illinois
United States	Oncology Specialists, S.C	Park Ridge	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Oncology Specialists, S.C.	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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