GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

Part of paid clinical trials in La Jolla, California.

Sponsor
Incyte Corporation
Study ID
NCT03139604
Phase
PHASE3
Status
Completed

Conditions

  • Graft-versus-host Disease (GVHD)

Eligibility Criteria

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

Interventions

  • Itacitinib — DRUG
    Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
  • Placebo — DRUG
    Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
  • Prednisone — DRUG
    Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
  • Methylprednisolone — DRUG
    Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.

Study Details

The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Key Dates

Start date
Jul 19, 2017
Status verified
Aug 2025
Primary completion
May 2, 2019
Completion
Jul 13, 2020

Study Design

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

Arms

  • Experimental: Itacitinib
    Itacitinib plus corticosteroids
  • Placebo Comparator: Placebo
    Matching placebo plus corticosteroids

Primary Outcome Measure

Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index [ Time Frame: Day 28 ]

Locations (49)

FacilityCityStateZIPSite coordinators
University of California, San Diego (UCSD) - Moores Cancer CenterLa JollaCalifornia92093-0698-
University of California, Los Angeles (UCLA) - Medical CenterLos AngelesCalifornia90095-1678-
University of Southern CaliforniaLos AngelesCalifornia90033-
Stanford Cancer CenterStanfordCalifornia94305-
University of Colorado - Aurora Cancer CenterAuroraColorado80045-
University of Florida (UF) - Division of Hematology & OncologyGainesvilleFlorida32610-
University of Miami - Sylvester Cancer CenterMiamiFlorida33136-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
University of ChicagoChicagoIllinois60637-
University of Illinois at ChicagoChicagoIllinois60612-
Advocate Lutheran General Hospital - Oncology Specialists SCPark RidgeIllinois60028-
Indiana Blood and Marrow TransplantIndianapolisIndiana46237-
Indiana University (IU) Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
University of Kansas Cancer CenterWestwoodKansas66205-
Tulane University Medical CenterNew OrleansLouisiana70112-
University of Maryland Medical CenterBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
University of MichiganAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Spectrum HealthGrand RapidsMichigan49503-
University of Mississippi Medical CenterJacksonMississippi39216-
Washington University School of MedicineSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-7680-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
John Theurer Cancer Center At Hackensack UMCHackensackNew Jersey07601-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-2681-
Northwell HealthLake SuccessNew York11042-
Columbia UniversityNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Stony Brook University Medical CenterStony BrookNew York11794-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Wake Forest Baptist Medical Center - Wake Forest University School of MedicineWinston-SalemNorth Carolina27157-
Oncology Hematology in CincinnatiCincinnatiOhio45236-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State University (OSU)ColumbusOhio43210-
University of Oklahoma - Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health & Science University (OHSU)PortlandOregon97239-3098-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterPittsburghPennsylvania15232-
Greenville Health SystemGreenvilleSouth Carolina29615-
Methodist Healthcare FoundationMemphisTennessee38104-
Sarah Cannon Research Institute, LLC (SCRI)NashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Transplant InstituteSan AntonioTexas78229-
University of Virginia Medical CenterCharlottesvilleVirginia22908-

Find similar trials in La Jolla, CA

By research site
University of California, San Diego (UCSD) - Moores Cancer Center· La Jolla, CAUniversity of California, Los Angeles (UCLA) - Medical Center· Los Angeles, CAUniversity of Southern California· Los Angeles, CAStanford Cancer Center· Stanford, CAUniversity of Colorado - Aurora Cancer Center· Aurora, COUniversity of Florida (UF) - Division of Hematology & Oncology· Gainesville, FL

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