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
18 Years
90 Years
Both
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Chadi Nabhan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oncology Specialists, SC
Authority:
United States: Institutional Review Board
Study ID:
0606
NCT ID:
NCT00413959
Start Date:
August 2006
Completion Date:
January 2011
Related Keywords:
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- NHL
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
|---|---|
| Onocology Specialists, S.C | Niles, Illinois 60714 |
| Oncology Specialists, S.C | Park Ridge, Illinois 60068 |
