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Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
This study is currently recruiting participants.
Study NCT00510887   Information provided by Duke University
First Received: August 1, 2007   Last Updated: April 23, 2009   History of Changes

August 1, 2007
April 23, 2009
January 2007
January 2012   (final data collection date for primary outcome measure)
complete and partial response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
complete and partial response [ Time Frame: 1year ]
Complete list of historical versions of study NCT00510887 on ClinicalTrials.gov Archive Site
toxicities [ Time Frame: 30 days from last dose of study drug ] [ Designated as safety issue: Yes ]
toxicities [ Time Frame: 30 days from last dose of study drug ]
 
Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma

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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Lymphoma, Follicular
Drug: Bortezomib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
37
June 2013
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Patty Davis, RN 919-668-1026 davis043@mc.duke.edu
United States
 
NCT00510887
David Rizzieri, MD, Duke University Medical Center
8785
Duke University
Millennium Pharmaceuticals, Inc.
Principal Investigator: David A Rizzieri, MD Duke University
Duke University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP