Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Opelika, Alabama.

Sponsor
Millennium Pharmaceuticals, Inc.
Study ID
NCT00312845
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bortezomib + Rituximab — DRUG
    VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5.
  • Rituximab — DRUG
    rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).

Study Details

The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

Key Dates

Start date
Mar 31, 2006
Status verified
Jun 2012
Primary completion
Jun 30, 2010
Completion
Jul 31, 2010

Study Design

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

Arms

  • Experimental: Bortezomib + Rituximab
  • Active Comparator: Rituximab

Primary Outcome Measure

Progression Free Survival [ Time Frame: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months. ]

Locations (41)

FacilityCityStateZIPSite coordinators
East Alabama Medical CenterOpelikaAlabama--
Central Hematology Oncology Medical Group, IncAlhambraCalifornia91801-
Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-
Providence Saint Joseph Medical CenterBurbankCalifornia91505-
St. Jude Heritage Medical GroupFullertonCalifornia92835-
Wilshire Oncology Medical Group, Inc.La VerneCalifornia91790-
Pacific Shores Medical GroupLong BeachCalifornia90813-
University of California, Los AngelesLos AngelesCalifornia90095-
University of Southern CaliforniaLos AngelesCalifornia90033-
North Valley Hematology OncologyMission HillsCalifornia91345-
University of California, Irvine Medical CenterOrangeCalifornia92868-
Ventura County Hematology-Oncology SpecialistsOxnardCalifornia93030-
Cancer Care Associates Medical Group, Inc.Redondo BeachCalifornia90277-
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454-
Norwalk Medical GroupNorwalkConnecticut--
Hematology Oncology PCStamfordConnecticut--
Integrated Community Oncology NetworkJacksonvilleFlorida--
Innovative Clinical Research of South FloridaMiamiFlorida--
Palm Beach Cancer InstituteWest Palm BeachFlorida--
Emory Univeersity ,Winship Cancer InstituteAtlantaGeorgia--
Suburban Hematology-Oncology AssociatesLawrencevilleGeorgia30045-
Northwest Georgia Oncology Centers, P.C.MariettaGeorgia30060-
North Idaho Cancer CenterCoeur d'AleneIdaho--
Investigative Clinical Research of IndianaIndianapolisIndiana--
Siouxland Hematolgoy-Oncology AssociatesSioux CityIowa--
Kansas City Cancer Center, LLCKansas CityKansas66210-
Louisville OncologyLouisvilleKentucky--
Hematology & Oncology SpecialistsMetairieLouisiana--
Sinai HospitalBaltimoreMaryland--
Hattiesburg ClinicHattesburgMissouri--
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27530-
Oregon Health & Science UniversityPortlandOregon--
Lancaster Cancer Center, Ltd.LancasterPennsylvania17601-
The Western Pennsylvania HospitalPittsburghPennsylvania--
South Carolina Oncology AssociatesColumbiaSouth Carolina--
South Carolina Oncology Associates, PAColumbiaSouth Carolina29210-
Vanderbilt UniversityNashvilleTennessee37232-
The Center for Cancer and Blood DisordersFort WorthTexas--
Oncology ConsultantsHoustonTexas777024-
South Texas Oncology and HematologySan AntonioTexas--
Medical College of Wisconsin MilwaukeeMilwaukeeWisconsin--

Find similar trials in Opelika, AL

By research site
East Alabama Medical Center· Opelika, ALCentral Hematology Oncology Medical Group, Inc· Alhambra, CAComprehensive Blood and Cancer Center· Bakersfield, CAProvidence Saint Joseph Medical Center· Burbank, CASt. Jude Heritage Medical Group· Fullerton, CAWilshire Oncology Medical Group, Inc.· La Verne, CA

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