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Phase II Study Investigating the Efficacy of VELCADEĀ®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma


Phase 2
18 Years
90 Years
Not Enrolling
Both
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

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Trial Information

Phase II Study Investigating the Efficacy of VELCADEĀ®, 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.CNiles, Illinois  60714
Oncology Specialists, S.CPark Ridge, Illinois  60068