Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT00850499
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • fludarabine — DRUG
    fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
  • rituximab — DRUG
    rituximab 375mg/m2 on Day 1 of every 35-day cycle
  • VELCADE — DRUG
    1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle

Study Details

This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

Key Dates

Start date
Sep 30, 2009
Status verified
Dec 2012
Primary completion
Sep 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VELCADE and fludarabine (Group A)
    VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
  • Active Comparator: fludarabine and rituximab (Group B)
    fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle

Primary Outcome Measure

Complete Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]

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