GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT ID: NCT03584516
Last Updated: 2025-10-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
155 participants
INTERVENTIONAL
2019-01-17
2023-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Part 1 : Dose determination of itacitinib
itacitinib administered in combination with corticosteroids.
Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Part 1 : Dose expansion of itacitinib
itacitinib administered in combination with corticosteroids or corticosteroids alone.
Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Placebo
In Part 2, participants will receive matching placebo.
Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Part 2 : itacitinib recommended dose from part 1
itacitinib or placebo administered in combination with corticosteroids
Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Interventions
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Itacitinib
In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
Placebo
In Part 2, participants will receive matching placebo.
Methylprednisolone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Prednisone
Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Underwent allogeneic stem cell transplantation (allo-HCT)
* Karnofsky Performance Status score ≥ 60%.
* Evidence of myeloid and platelet engraftment.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria
* Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP).
* Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
* cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence.
* Evidence of relapsed primary malignancy.
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 Arizona Cancer Center - Out Pt.
Tucson, Arizona, United States
University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute
Little Rock, Arkansas, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Medical Center, Moores Cancer Center
La Jolla, California, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Augusta University - Medical College of Georgia
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Cancer Specialists
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Lutheran General Hospital - Oncology Specislists Sc
Park Ridge, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Kansas Hospital Authority
Westwood, Kansas, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Tri Star Bone Marrow Transplant
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
St David'S South Austin Medical Center
Austin, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz, , Austria
Zna Stuivenberg
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, , Belgium
CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN
Liège, , Belgium
AZ DELTA
Roeselare, , Belgium
University of Alberta
Edmonton, Alberta, Canada
University Health Network
Toronto, Ontario, Canada
Hospital Maisonneuve Rosemont
Montreal, Quebec, Canada
Saskatchewan Cancer
Saskatoon, Saskatchewan, Canada
The Finsen Centre National Hospital
Copenhagen, , Denmark
Turku University Hospital
Turku, , Finland
Chu Amiens Picardie - Hopital Sud
Amiens, , France
Centre Hospitalier D'Angers
Angers, , France
Chu de Grenoble - Hopital Albert Michallon
Grenoble, , France
Institut Paoli-Calmettes
Marseille, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, , France
Chu de Nice - Hospital L Archet
Nice, , France
Chu de Rennes - Hospital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Chru Hopitaux de Tours Hospital Bretonneau
Tours, , France
Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Charite Berlin
Berlin, , Germany
Universitatsklinikum Bonn Aoer
Bonn, , Germany
Universitatsklinikum Koln
Cologne, , Germany
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, , Germany
Universitaetsklinikum Erlangen - Medizinische Klinik 5
Erlangen, , Germany
Universitatsklinikum Essen
Essen, , Germany
UNIVERSIT�TSKLINIKUM HALLE (SAALE)
Halle, , Germany
University Medical Centre Hamburg-Eppendorf Centre of Oncology
Hamburg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie
Leipzig, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
University Hospital Mannheim
Mannheim, , Germany
Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen
Munich, , Germany
Universitatsklinikum Munster
Münster, , Germany
Universitaetsmedizin Rostock
Rostock, , Germany
Universitaetsklinikum in Tubingen
Tübingen, , Germany
University Hospital of West Attica - Attikon
Chaïdári, , Greece
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki, , Greece
Rambam Medical Center
Haifa, , Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital
Petach Tiqwa, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
CLINICA DI EMATOLOGIA, UNIVERSIT� POLITECNICA DELLE MARCHE
Ancona, , Italy
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, , Italy
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
Bologna, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, , Italy
Azienda Policlinico Vittorio Emanuele
Catania, , Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, , Italy
A.O.U. Di Modena - Policlinico
Modena, , Italy
A.O.U. Federico Ii
Napoli, , Italy
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
Palermo, , Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
Reggio Calabria, , Italy
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
Roma, , Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Roma, , Italy
Irrcs Instituto Clinico Humanitas
Rozzano, , Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino, , Italy
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
Udine, , Italy
Centro Ricerche Cliniche Di Verona (Crc)
Verona, , Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi
Gliwice, , Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan, , Poland
Mtz Clinical Research Sp. Zo.O.
Warsaw, , Poland
Institut Catala D Oncologia
Badalona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Ico Institut Catala D Oncologia
L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Son Espases University Hospital
Palma, , Spain
Clinica Universidad de Navarra (Cun)
Pamplona, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clinico de Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Universitario Y Politcnico de La Fe
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Karolinska University Hospital Huddinge
Huddinge, , Sweden
Skane University Hospital Lund
Lund, , Sweden
Universitatsspital Zurich
Zurich, , Switzerland
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Barts Health Nhs Trust - St Bartholomews Hospital
London, , United Kingdom
King'S College Hospital (Nhs Foundation)
London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, , United Kingdom
Nottingham University Hospitals Nhs Trust
Nottingham, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, , United Kingdom
St. George'S University Hospitals Nhs Foundation Trust
Tooting, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001606-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 39110-309
Identifier Type: -
Identifier Source: org_study_id
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