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| 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 |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
|
follicular lymphoma Velcade VR-FND |
|
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 |