GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Who is this study for? Patients with Graft versus Host Disease
What treatments are being studied? Itacitinib+Methylprednisolone+Prednisone
Status: Terminated
Location: See all (133) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus 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.
Locations
United States
Arkansas
University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute
Little Rock
Arizona
University of Arizona Cancer Center - Out Pt.
Tucson
California
City of Hope National Medical Center
Duarte
University of California San Diego Medical Center, Moores Cancer Center
La Jolla
Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami
Georgia
Winship Cancer Institute of Emory University
Atlanta
Augusta University - Medical College of Georgia
Augusta
Illinois
Illinois Cancer Specialists
Chicago
Rush University Medical Center
Chicago
Loyola University Medical Center
Maywood
Advocate Lutheran General Hospital - Oncology Specislists Sc
Park Ridge
Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis
Kansas
University of Kansas Hospital Authority
Westwood
Louisiana
Tulane University
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Maryland
University of Maryland - Greenebaum Cancer Center
Baltimore
Michigan
University of Michigan
Ann Arbor
Henry Ford Health System
Detroit
Spectrum Health
Grand Rapids
Minnesota
University of Minnesota, Masonic Cancer Center
Minneapolis
Missouri
Saint Louis University Cancer Center
Saint Louis
North Carolina
Duke University Medical Center
Durham
New Jersey
Hackensack University Medical Center
Hackensack
New York
University of Rochester, James P. Wilmot Cancer Center
Rochester
Stony Brook University Medical Center
Stony Brook
Ohio
Oncology Hematology Care, Inc
Cincinnati
University Hospitals Cleveland Medical Center
Cleveland
Pennsylvania
Jefferson University Hospitals
Philadelphia
University of Pennsylvania Abramson Cancer Center
Philadelphia
University of Pittsburgh
Pittsburgh
Western Pennsylvania Hospital
Pittsburgh
South Dakota
Avera Cancer Institute
Sioux Falls
Tennessee
Tri Star Bone Marrow Transplant
Nashville
Vanderbilt-Ingram Cancer Center
Nashville
Texas
St David'S South Austin Medical Center
Austin
Texas Oncology - Baylor Sammons Cancer Center
Dallas
Texas Oncology - Medical City Dallas
Dallas
Washington
Fred Hutchinson Cancer Research Center
Seattle
Other Locations
Austria
Ordensklinikum Linz Gmbh Elisabethinen
Linz
Belgium
Zna Stuivenberg
Antwerpen
Institut Jules Bordet
Brussels
Universitair Ziekenhuis Antwerpen (Uza)
Edegem
Universitair Ziekenhuis Gent
Gent
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven
CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN
Liege
AZ DELTA
Roeselare
Canada
University of Alberta
Edmonton
Hospital Maisonneuve Rosemont
Montreal
Saskatchewan Cancer
Saskatoon
University Health Network
Toronto
Denmark
The Finsen Centre National Hospital
Copenhagen
Finland
Turku University Hospital
Turku
France
Chu Amiens Picardie - Hopital Sud
Amiens
Centre Hospitalier D'Angers
Angers
Chu de Grenoble - Hopital Albert Michallon
Grenoble Cedex
Institut Paoli-Calmettes
Marseille
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes
Chu de Nice - Hospital L Archet
Nice
Chu de Rennes - Hospital Pontchaillou
Rennes
Centre Henri Becquerel
Rouen
Chru Hopitaux de Tours Hospital Bretonneau
Tours
Hopitaux de Brabois
Vandoeuvre Les Nancy
Germany
Charite Berlin
Berlin
Universitatsklinikum Bonn Aoer
Bonn
University Clinic Carl Gustav Carus Technical University Dresden
Dresden
Universitaetsklinikum Erlangen - Medizinische Klinik 5
Erlangen
Universitatsklinikum Essen
Essen
UNIVERSIT�TSKLINIKUM HALLE (SAALE)
Halle
University Medical Centre Hamburg-Eppendorf Centre of Oncology
Hamburg
Universitaetsklinikum Jena
Jena
Universitatsklinikum Koln
Koeln
Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie
Leipzig
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz
University Hospital Mannheim
Mannheim
Universitatsklinikum Munster
Muenster
Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen
Munich
Universitaetsmedizin Rostock
Rostock
Universitaetsklinikum in Tubingen
Tubingen
Greece
University Hospital of West Attica - Attikon
Chaidari
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki
Israel
Rambam Medical Center
Haifa
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem
Rabin Medical Center - Beilinson Hospital
Petach Tiqwa
Tel Aviv Sourasky Medical Center
Tel Aviv-yafo
Italy
CLINICA DI EMATOLOGIA, UNIVERSIT� POLITECNICA DELLE MARCHE
Ancona
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
Bologna
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia
Azienda Policlinico Vittorio Emanuele
Catania
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milano
A.O.U. Di Modena - Policlinico
Modena
A.O.U. Federico Ii
Napoli
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
Reggio Calabria
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Roma
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
Roma
Irrcs Instituto Clinico Humanitas
Rozzano
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
Udine
Centro Ricerche Cliniche Di Verona (Crc)
Verona
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi
Gliwice
Szpital Kliniczny Przemienienia Panskiego
Poznan
Mtz Clinical Research Sp. Zo.O.
Warszawa
Spain
Institut Catala D Oncologia
Badalona
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital Universitario Virgen de Las Nieves
Granada
Ico Institut Catala D Oncologia
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario Ramon Y Cajal
Madrid
Hospital Regional Universitario de Malaga
Malaga
Son Espases University Hospital
Palma
Clinica Universidad de Navarra (Cun)
Pamplona
Hospital Clinico Universitario de Salamanca
Salamanca
Hospital Universitario Marques de Valdecilla
Santander
Hospital Clinico de Santiago de Compostela
Santiago De Compostela
Hospital Clinico Universitario de Valencia
Valencia
Hospital Universitario Y Politcnico de La Fe
Valencia
Sweden
Karolinska University Hospital Huddinge
Huddinge
Skane University Hospital Lund
Lund
Switzerland
Universitatsspital Zurich
Zurich
United Kingdom
Bristol Haematology & Oncology Centre
Bristol
University Hospital of Wales
Cardiff
Barts Health Nhs Trust - St Bartholomews Hospital
London
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London
King'S College Hospital (Nhs Foundation)
London
Nottingham University Hospitals Nhs Trust
Nottingham
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton
St. George'S University Hospitals Nhs Foundation Trust
Tooting
Time Frame
Start Date: 2019-01-17
Completion Date: 2023-11-03
Participants
Target number of participants: 155
Treatments
Experimental: Part 1 : Dose determination of itacitinib
itacitinib administered in combination with corticosteroids.
Experimental: Part 1 : Dose expansion of itacitinib
itacitinib administered in combination with corticosteroids or corticosteroids alone.
Placebo_comparator: Part 2 : itacitinib recommended dose from part 1
itacitinib or placebo administered in combination with corticosteroids
Authors
Dr. Nalini Janakiraman, Dr. Tessa Kerre, Dr. Mohammad Abu Zaid, Dr. Anna Koget, Dr. Jana Reynolds, Dr. Vikas Bhushan, Dr. Madan Jagasia, Dr. Leonard Klein, Dr. Carlos Bachier, Dr. Vamsi Kota, Dr. Michael Schuster, Dr. Sami Brake, Prof. Dr. Wolfgang Bethge, Dr. Inken Hilgendorf, Dr. Sebastian Kreil, Dr. Marc Bernard, Dr. Annie Im, Dr. Mitchell Horwitz, Dr. Keri Maher, Dr. Zachariah Defilipp, Dr. Kellie Sprague, Dr. Rosanna Scime, Dr. Fabio Benedetti, Dr. Alain Gadisseur, Dr. Anabelle Chinea, Dr. Sebastian Wittnebel, Dr. Dries Deeren, Dr. Wendy Ingram, Dr. Dimitri Breems, Dr. Georg-Nikolaus Franke, Dr. Grzegorz Basak, Dr. Carlos Solano, Dr. Jan Moritz Middeke, Prof. Attilio Olivieri, Fabrizio Pane
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation