A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
complete and partial response
David A Rizzieri, MD
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|