A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT00636792
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • VELCADE — DRUG
    VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.
  • Bendamustine — DRUG
    Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle
  • Rituximab — DRUG
    Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5

Study Details

This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Key Dates

Start date
Feb 29, 2008
Status verified
Jan 2012
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: 1
    This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Primary Outcome Measure

Number of Participants With Complete Response [ Time Frame: 12 weeks after the last subject completes their end of treatment visit. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20057-
MidDakota Clinic - Cancer Treatment and Research CenterBismarckNorth Dakota58501-

Find similar trials in Washington D.C., DC

By research site
Georgetown University Medical Center· Washington D.C., DCMidDakota Clinic - Cancer Treatment and Research Center· Bismarck, ND

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