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VELCADE,Rituximab,Cyclophosphamide and Decadron (VRCD)

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ClinicalTrials.gov Identifier: NCT00413959
Recruitment Status : Terminated
First Posted : December 20, 2006
Results First Posted : September 27, 2013
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, 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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Lymphoma, B-Cell Drug: VELCADE® Drug: Rituximab Drug: Cyclophosphamide Drug: Decadron Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011


Arm Intervention/treatment
Experimental: Velcade, Rituximab,Cyclophosphamide & 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.
Drug: VELCADE®
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
Other Name: Bortezomib

Drug: 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.
Other Name: Rituxan

Drug: Cyclophosphamide
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Other Name: Cytoxan

Drug: Decadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Other Name: dexamethasone




Primary Outcome Measures :
  1. Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. [ Time Frame: 4 years ]
    Percentage of complete responders plus percentage of partial responders equals overall response rate.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 4 years ]
    The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413959


Locations
United States, Illinois
Onocology Specialists, S.C
Niles, Illinois, United States, 60714
Oncology Specialists, S.C
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Oncology Specialists, S.C.
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, SC

Responsible Party: Dr. Sigrun Hallmeyer, Director of Research, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00413959     History of Changes
Other Study ID Numbers: 0606
First Posted: December 20, 2006    Key Record Dates
Results First Posted: September 27, 2013
Last Update Posted: September 19, 2018
Last Verified: August 2018

Keywords provided by Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.:
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Bortezomib
Dexamethasone
Dexamethasone acetate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids