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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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive PCP prophylaxis with TMP/Sulfa or equivalent agent. On day 4 the physician has the option of starting GCSF, GMCSF, or pegylated GCSF.
All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.
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| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | David A Rizzieri, MD | Duke University |
More Information
| Responsible Party: | David Rizzieri, MD, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00510887 History of Changes |
| Other Study ID Numbers: | 00008487, 8785 |
| Study First Received: | August 1, 2007 |
| Last Updated: | May 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
follicular lymphoma Velcade VR-FND |
|
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |