VELCADE,Rituximab,Cyclophosphamide and Decadron

Phase 2

Terminated

• Conditions: Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Interventions: Drug: VELCADE®; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Decadron

• Registration Number: NCT00413959
• Lead Sponsor: Oncology Specialists, S.C.

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2013-05-07
• Results First Submitted QC: 2013-08-06
• Results First Posted: 2013-09-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Velcade, Rituximab,Cyclophosphamide & Decadron	Rituximab	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.
Velcade, Rituximab,Cyclophosphamide & Decadron	Cyclophosphamide	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.
Velcade, Rituximab,Cyclophosphamide & Decadron	VELCADE®	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.
Velcade, Rituximab,Cyclophosphamide & Decadron	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.	4 years	Percentage of complete responders plus percentage of partial responders equals overall response rate.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	4 years	The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.

Trial Locations

Locations (2)

Onocology Specialists, S.C; 🇺🇸 Niles, Illinois, United States

Oncology Specialists, S.C; 🇺🇸 Park Ridge, Illinois, United States