Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
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.
|Study Design:||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|
- complete and partial response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- toxicities [ Time Frame: 30 days from last dose of study drug ] [ Designated as safety issue: Yes ]
- Time to disease progression [ Time Frame: From treatment to disease progression ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: from treatment to progression or death, whichever comes first ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From treatment to death of any cause ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||September 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.
Each cycle will be repeated every 28 days for 8 cycles maximum.
Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Other Name: VelcadeDrug: Rituximab
Rituximab 375 mg/m2 IV on day 1Drug: Fludarabine
Fludarabine 25 mg/m2 IV on days 1,2,3Drug: Mixantrone
Mitoxantrone 10 mg/m2 IV on day 2
Other Name: NovantroneDrug: Dexamethasone
Dexamethasone 20 mg orally on days 1,2,3,4,5
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.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David A Rizzieri, MD||Duke University|