Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kyowa Kirin, Inc.
Study ID
NCT01728805
Phase
PHASE3
Status
Completed

Conditions

  • Cutaneous T-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • KW-0761 — BIOLOGICAL
    1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
  • Vorinostat — DRUG

Study Details

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Key Dates

Start date
Nov 30, 2012
Status verified
Apr 2024
Primary completion
Mar 31, 2017
Completion
Feb 17, 2021

Study Design

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

Arms

  • Experimental: KW-0761
    anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
  • Active Comparator: Vorinostat
    vorinostat 400 mg once daily

Primary Outcome Measure

Progression Free Survival [ Time Frame: From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]

Locations (34)

FacilityCityStateZIPSite coordinators
University of Alabama - BirminghamBirminghamAlabama35233-
Banner MD AndersonGilbertArizona85234-
City of Hope National Medical CenterDuarteCalifornia91010-
UCLA Medical CenterLos AngelesCalifornia90095-
Stanford Medical CenterStanfordCalifornia94305-
University of ColoradoAuroraColorado80045-
Yale University School of Medicine - Yale Cancer CenterNew HavenConnecticut06520-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
The Winship Cancer Institute (Emory University)AtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Indiana UniversityIndianapolisIndiana46202-
University of Kansas Cancer CenterWestwoodKansas66205-
Tulane University Medical CenterNew OrleansLouisiana70112-
Boston Medical Center, Department of Medicine, Section of Hem/OncBostonMassachusetts02118-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Universal Dermatology, PLLCFairportNew York14450-
Columbia PresbyterianNew YorkNew York10037-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Rochester School of MedicineRochesterNew York14642-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh School of MedicinePittsburghPennsylvania15208-
Vanderbilt University Medical CenterNashvilleTennessee37232-
M.D.Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
University of WashingtonSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53266-

Find similar trials in Birmingham, AL

By research site
University of Alabama - Birmingham· Birmingham, ALBanner MD Anderson· Gilbert, AZCity of Hope National Medical Center· Duarte, CAUCLA Medical Center· Los Angeles, CAStanford Medical Center· Stanford, CAUniversity of Colorado· Aurora, CO

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