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Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
This study is currently recruiting participants.
Verified by Duke University, April 2009
First Received: August 1, 2007   Last Updated: April 23, 2009   History of Changes
Sponsor: Duke University
Collaborator: Millennium Pharmaceuticals, Inc.
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00510887
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients with follicular cell lymphoma.


Condition Intervention Phase
Lymphoma, Follicular
Drug: Bortezomib
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • complete and partial response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicities [ Time Frame: 30 days from last dose of study drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: January 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bortezomib
    Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
  • No prior bortezomib therapy.
  • Voluntary written informed consent.
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
  • Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
  • 18 years of age or older.
  • AST, ALT, total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
  • ECOG performance status 0-2.

Exclusion Criteria:

  • Platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
  • Absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
  • Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
  • ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
  • Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
  • Female subject is pregnant or lactating.
  • Received other investigational drugs for this disease within 14 days of enrollment
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Known HIV+ status.
  • Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, MUGA or cardiac MRI.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510887

Contacts
Contact: Patty Davis, RN 919-668-1026 davis043@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Patty Davis, RN     919-668-1026     davis043@mc.duke.edu    
Contact: Donna Adams, RN     919-668-4716     adams068@mc.duke.edu    
Principal Investigator: David A. Rizzieri, MD            
Sponsors and Collaborators
Duke University
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: David A Rizzieri, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University Medical Center ( David Rizzieri, MD )
Study ID Numbers: 8785
Study First Received: August 1, 2007
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00510887     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
follicular lymphoma
Velcade
VR-FND

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Bortezomib
Lymphoma, Follicular
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009