GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
NCT ID: NCT03139604
Last Updated: 2025-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
439 participants
INTERVENTIONAL
2017-07-19
2020-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Itacitinib
Itacitinib plus corticosteroids
Itacitinib
Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Prednisone
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
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
Placebo
Matching placebo plus corticosteroids
Placebo
Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
Prednisone
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
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
Interventions
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Itacitinib
Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Placebo
Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
Prednisone
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
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.
* Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
* Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation.
* Willing to avoid pregnancy or fathering children.
* Able to give written informed consent and comply with all study visits and procedures.
* Able to swallow and retain oral medication.
Exclusion Criteria
* Has received more than 2 days of systemic corticosteroids for aGVHD.
* Presence of GVHD overlap syndrome.
* Presence of an active uncontrolled infection.
* Known human immunodeficiency virus infection.
* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
* Any corticosteroid therapy for indications other than GVHD at doses \> 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
* Severe organ dysfunction unrelated to underlying GVHD, including:
* Cholestatic disorders or unresolved veno-occlusive disease of the liver.
* Clinically significant or uncontrolled cardiac disease.
* Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
* Currently breast feeding.
* Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
* Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
* Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Rodica Morariu-Zamfir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
University of Florida (UF) - Division of Hematology & Oncology
Gainesville, Florida, United States
University of Miami - Sylvester Cancer Center
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Advocate Lutheran General Hospital - Oncology Specialists SC
Park Ridge, Illinois, United States
Indiana University (IU) Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Indiana Blood and Marrow Transplant
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Northwell Health
Lake Success, New York, United States
Columbia University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Oncology Hematology in Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University (OSU)
Columbus, Ohio, United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
Methodist Healthcare Foundation
Memphis, Tennessee, United States
Sarah Cannon Research Institute, LLC (SCRI)
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Transplant Institute
San Antonio, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
St Vincents Hospital Sydney Limited
Darlinghurst, , Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
ZNA Stuivenberg
Antwerp, , Belgium
General Hospital Sint-Jan Brugge-Oostend
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent (UZG)
Ghent, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Hopital universitaire du Sart Tilman de Liege
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
UHKT Prague - Institute of Hematology and Blood Transfusion
Prague, , Czechia
Helsinki University Central Hospital
Helsinki, , Finland
CHU Amiens Picardie - Hopital Sud
Amiens, , France
CHRU de Lille-Hopital Claude Huriez
Lille, , France
Hotel Dieu Hospital - Hematologie
Nantes, , France
Hopital Saint Louis
Paris, , France
Hopital Haut Leveque - CHU Bordeaux - Maladies du sang
Pessac, , France
Hopital de Hautepierre
Strasbourg, , France
Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol
Toulouse, , France
CHU de Nancy
Vandœuvre-lès-Nancy, , France
Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)
Cologne, , Germany
University Clinic Carl Gustav Carus, Technical University Dresden
Dresden, , Germany
Universitatsklinikum Freiburg - Klinik fur Innere Medizin I
Freiburg im Breisgau, , Germany
Universitatsklinikum Hamburg - Eppendorf
Hamburg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitaetsmedizin der Johannes Gutenberg
Mainz, , Germany
UKGM Marburg Innere Medizin: Haematologie Onkolog
Marburg, , Germany
General Hospital of Thessaloniki G. Papanikolaou - Hematology Department
Chortiatis, , Greece
Rambam Health Care Campus
Haifa, , Israel
Hadassah Hebrew University Medical Center Ein Karem
Jerusalem, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, , Italy
C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari
Cagliari, , Italy
Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi
Catania, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza
Monza, , Italy
Casa di Cura La Maddalena
Palermo, , Italy
Fondazione IRCCS Policlinco San Matteo
Pavia, , Italy
Presidio Ospedaliero Pescara
Pescara, , Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
Reggio Calabria, , Italy
Azienda Unità Sanitaria Locale di Reggio Emilia
Reggio Emilia, , Italy
University of Rome La Sapienza
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
A.O.U. Città della Salute e della Scienza di Torino
Torino, , Italy
SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine
Udine, , Italy
Auckland District Health Board
Auckland, , New Zealand
Centrum Onkologii- Instytut w Gliwicach
Gliwice, , Poland
Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Seoul National University Hospital
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Barcelona, , Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario de Donostia
San Sebastián, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clinico de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Universtity Hospital Basel - Haematology
Basel, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Universitaetsspital Zuerich - Klinik fuer Haematology
Zurich, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Nottingham University Hospitals
Nottingham, , United Kingdom
Countries
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References
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Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.
Zeiser R, Socie G, Schroeder MA, Abhyankar S, Vaz CP, Kwon M, Clausen J, Volodin L, Giebel S, Chacon MJ, Meyers G, Ghosh M, Deeren D, Sanz J, Morariu-Zamfir R, Arbushites M, Lakshminarayanan M, Barbour AM, Chen YB. Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial. Lancet Haematol. 2022 Jan;9(1):e14-e25. doi: 10.1016/S2352-3026(21)00367-7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 39110-301
Identifier Type: -
Identifier Source: org_study_id
2017-000538-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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