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VELCADE,Rituximab,Cyclophosphamide and Decadron (VRCD)

O

Oncology Specialists, S.C.

Status and phase

Terminated
Phase 2

Conditions

Lymphoma, B-Cell
Lymphoma, Non-Hodgkin

Treatments

Drug: VELCADE®
Drug: Decadron
Drug: Rituximab
Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Velcade, Rituximab,Cyclophosphamide & Decadron
Experimental group
Description:
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.
Treatment:
Drug: VELCADE®
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Decadron

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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