Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT00510887
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
  • Rituximab — DRUG
    Rituximab 375 mg/m2 IV on day 1
  • Fludarabine — DRUG
    Fludarabine 25 mg/m2 IV on days 1,2,3
  • Mitoxantrone — DRUG
    Mitoxantrone 10 mg/m2 IV on day 2
  • Dexamethasone — DRUG
    Dexamethasone 20 mg orally on days 1,2,3,4,5

Study Details

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.

Key Dates

Start date
Jan 31, 2007
Status verified
Apr 2014
Primary completion
Nov 30, 2012
Completion
Sep 30, 2013

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VR-FND
    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.

Primary Outcome Measure

Complete and Partial Response [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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