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| Descriptive Information Fields | |||||
| Brief Title † | Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma | ||||
| Official Title † | A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | complete and partial response [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | toxicities [ Time Frame: 30 days from last dose of study drug ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Lymphoma, Follicular | ||||
| Intervention † | Drug: Bortezomib | ||||
| MEDLINE PMIDs | |||||
| Links | Duke Hematologic Malignancy Program ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 37 | ||||
| Start Date † | January 2007 | ||||
| Completion Date | June 2013 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00510887 | ||||
| Organization ID | 8785 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Duke University | ||||
| Collaborators †† | Millennium Pharmaceuticals | ||||
| Investigators † |
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| Information Provided By | Duke University | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | August 1, 2007 | ||||
| Last Updated Date | August 13, 2008 | ||||