Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Cephalon
Study ID
NCT01073163
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    Bendamustine at 90 mg/m\^2 IV on Days 1 and 2 of a 28-day cycle.
  • Rituximab — DRUG
    Rituximab at 375 mg/m\^2 IV on Day 1 of a 28-day cycle.

Study Details

The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).

Key Dates

Start date
Feb 28, 2010
Status verified
Apr 2014
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

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

Arms

  • Experimental: Bendamustine with Rituximab
    Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m\^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m\^2 on Day 1 of each 28-day cycle.

Primary Outcome Measure

Mean Change From Baseline in QT Interval as Corrected by the Fridericia Method (QTcF) at End of Infusion [ Time Frame: Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion. ]

Locations (36)

FacilityCityStateZIPSite coordinators
Hematology Oncology Physicans Extenders GroupTucsonArizona--
University of Arkansas for Medical SciencesLittle RockArkansas--
St. Jude Heritage Medical GroupFullertonCalifornia--
Comprehensive Cancer CenterPalm SpringsCalifornia--
University of Colorado Cancer CenterAuroraColorado--
Rocky Mountain Cancer CenterDenverColorado--
The Hospital of Central ConnecticutNew BritainConnecticut--
Cancer Center of Central ConnecticutSouthingtonConnecticut--
Memorial Cancer InstituteHollywoodFlorida--
Cancer Centers of FloridaOrlandoFlorida--
MD Anderson Cancer Cnt OrlandoOrlandoFlorida--
John B Amos Cancer CenterColumbusGeorgia--
St Francis Cancer Research FoundationBeech GroveIndiana--
Cedar Valley Medical SpecialistsWaterlooIowa--
Cancer Center of KansasWichitaKansas--
University of KentuckyLexingtonKentucky--
LSU Health Sciences Center - ShreveportShreveportLouisiana--
MaineGeneral Medical CenterAugustaMaine--
Missouri Cancer AssociatesColumbiaMissouri--
Kansas City Cancer CenterKansas CityMissouri--
UNM Cancer Center/New Mexico Cancer Care AllianceAlbuquerqueNew Mexico--
Interlakes Foundation, IncRochesterNew York--
SUNY Upstate / Upstate Medical UniversitySyracuseNew York--
Willamette Valley Cancer CenterSpringfieldOregon--
Geisinger Medical CenterDanvillePennsylvania--
Pennsylvania Oncology Hematology Associates, Inc.PhiladelphiaPennsylvania--
Charleston Hematology Oncology, PACharlestonSouth Carolina--
Sarah Cannon Cancer CenterNashvilleTennessee--
Texas Oncology, P.A.Fort WorthTexas--
Cancer Care Center of South TexasSan AntonioTexas--
Texas OncologyTylerTexas--
Virginia Oncology AssociatesNorfolkVirginia--
Cancer Outreach Asscociates, PCRichlandsVirginia--
Cancer Care Northwest-SouthSpokaneWashington--
Northwest Cancer Specialists, PCVancouverWashington--
West Virginia University School of MedicineMorgantownWest Virginia--

Find similar trials in Tucson, AZ

By research site
Hematology Oncology Physicans Extenders Group· Tucson, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARSt. Jude Heritage Medical Group· Fullerton, CAComprehensive Cancer Center· Palm Springs, CAUniversity of Colorado Cancer Center· Aurora, CORocky Mountain Cancer Center· Denver, CO

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