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Sponsors and Collaborators: |
Duke University Millennium Pharmaceuticals, Inc. |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00510887 |
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 |
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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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patty Davis, RN | 919-668-1026 | davis043@mc.duke.edu |
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 |
Principal Investigator: | David A Rizzieri, MD | Duke University |
Responsible Party: | Duke University Medical Center ( David Rizzieri, MD ) |
Study ID Numbers: | 8785 |
Study First Received: | August 1, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00510887 |
Health Authority: | United States: Institutional Review Board |
follicular lymphoma Velcade VR-FND |
Dexamethasone Immunoproliferative Disorders Rituximab Bortezomib Lymphoma, Follicular Fludarabine monophosphate Lymphatic Diseases |
Mitoxantrone Fludarabine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Follicular lymphoma Dexamethasone acetate |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |