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GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Primary Purpose

Chronic Graft-versus-host Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Itacitinib
Placebo
Methylprednisolone
Prednisone
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft-versus-host Disease focused on measuring Graft-versus-host-disease, itacitinib, Janus kinase inhibitor, corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
  • 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.

Sites / Locations

  • University of Arizona Cancer Center - Out Pt.
  • University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute
  • City of Hope National Medical Center
  • University of California San Diego Medical Center, Moores Cancer Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Winship Cancer Institute of Emory University
  • Augusta University - Medical College of Georgia
  • Rush University Medical Center
  • Illinois Cancer Specialists
  • Loyola University Medical Center
  • Advocate Lutheran General Hospital - Oncology Specislists Sc
  • Indiana University Melvin and Bren Simon Cancer Center
  • University of Kansas Hospital Authority
  • Tulane University
  • University of Maryland - Greenebaum Cancer Center
  • Tufts Medical Center
  • Massachusetts General Hospital
  • University of Michigan
  • Henry Ford Health System
  • Spectrum Health
  • University of Minnesota, Masonic Cancer Center
  • Saint Louis University Cancer Center
  • Hackensack University Medical Center
  • University of Rochester, James P. Wilmot Cancer Center
  • Stony Brook University Medical Center
  • Duke University Medical Center
  • Oncology Hematology Care, Inc
  • University Hospitals Cleveland Medical Center
  • University of Pennsylvania Abramson Cancer Center
  • Jefferson University Hospitals
  • Western Pennsylvania Hospital
  • University of Pittsburgh
  • Avera Cancer Institute
  • Tri Star Bone Marrow Transplant
  • Vanderbilt-Ingram Cancer Center
  • St David'S South Austin Medical Center
  • Texas Oncology - Medical City Dallas
  • Texas Oncology - Baylor Sammons Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Ordensklinikum Linz Gmbh Elisabethinen
  • Zna Stuivenberg
  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen (Uza)
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN
  • AZ DELTA
  • University of Alberta
  • University Health Network
  • Hospital Maisonneuve Rosemont
  • Saskatchewan Cancer
  • The Finsen Centre National Hospital
  • Turku University Hospital
  • Chu Amiens Picardie - Hopital Sud
  • Centre Hospitalier D'Angers
  • Chu de Grenoble - Hopital Albert Michallon
  • Institut Paoli-Calmettes
  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Chu de Nice - Hospital L Archet
  • Chu de Rennes - Hospital Pontchaillou
  • Centre Henri Becquerel
  • Chru Hopitaux de Tours Hospital Bretonneau
  • Hopitaux de Brabois
  • Charite Berlin
  • Universitatsklinikum Bonn Aoer
  • University Clinic Carl Gustav Carus Technical University Dresden
  • Universitaetsklinikum Erlangen - Medizinische Klinik 5
  • Universitatsklinikum Essen
  • UNIVERSIT�TSKLINIKUM HALLE (SAALE)
  • University Medical Centre Hamburg-Eppendorf Centre of Oncology
  • Universitaetsklinikum Jena
  • Universitatsklinikum Koln
  • Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • University Hospital Mannheim
  • Universitatsklinikum Munster
  • Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen
  • Universitaetsmedizin Rostock
  • Universitaetsklinikum in Tubingen
  • University Hospital of West Attica - Attikon
  • General Hospital of Thessaloniki G. Papanikolaou
  • Rambam Medical Center
  • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Rabin Medical Center - Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • CLINICA DI EMATOLOGIA, UNIVERSIT� POLITECNICA DELLE MARCHE
  • Azienda Ospedaliera Papa Giovanni Xxiii
  • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
  • Azienda Policlinico Vittorio Emanuele
  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
  • Fondazione Irccs Ca Granda Ospedale Maggiore
  • A.O.U. Di Modena - Policlinico
  • A.O.U. Federico Ii
  • Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
  • Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
  • Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
  • Irrcs Instituto Clinico Humanitas
  • I.R.C.C.S. Casa Sollievo Della Sofferenza
  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
  • Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
  • Centro Ricerche Cliniche Di Verona (Crc)
  • Uniwersyteckie Centrum Kliniczne
  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi
  • Szpital Kliniczny Przemienienia Panskiego
  • Mtz Clinical Research Sp. Zo.O.
  • Institut Catala D Oncologia
  • Hospital de La Santa Creu I Sant Pau
  • Hospital Universitario Virgen de Las Nieves
  • Ico Institut Catala D Oncologia
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon Y Cajal
  • Hospital Regional Universitario de Malaga
  • Son Espases University Hospital
  • Clinica Universidad de Navarra (Cun)
  • Hospital Clinico Universitario de Salamanca
  • Hospital Universitario Marques de Valdecilla
  • Hospital Clinico de Santiago de Compostela
  • Hospital Universitario Y Politcnico de La Fe
  • Hospital Clinico Universitario de Valencia
  • Karolinska University Hospital Huddinge
  • Skane University Hospital Lund
  • Universitatsspital Zurich
  • Bristol Haematology & Oncology Centre
  • University Hospital of Wales
  • Barts Health Nhs Trust - St Bartholomews Hospital
  • King'S College Hospital (Nhs Foundation)
  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital
  • Nottingham University Hospitals Nhs Trust
  • The Royal Marsden Nhs Foundation Trust - Sutton
  • St. George'S University Hospitals Nhs Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1 : Dose determination of itacitinib

Part 1 : Dose expansion of itacitinib

Part 2 : itacitinib recommended dose from part 1

Arm Description

itacitinib administered in combination with corticosteroids.

itacitinib administered in combination with corticosteroids or corticosteroids alone.

itacitinib or placebo administered in combination with corticosteroids

Outcomes

Primary Outcome Measures

Part 1 : Dose Determination: Number of dose-limiting toxicities
To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
Part 2 : Response rate
Defined as the proportion of participants demonstrating a complete response (CR) or partial response (PR) per National Institutes of Health (NIH) consensus guideline.
Part 1 : Dose Expansion: Number of dose-limiting toxicities
To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.

Secondary Outcome Measures

Part 1, 1 expansion, and Part 2: Cmax of itacitinib when administered in combination with corticosteroids
Maximum observed concentration.
Part 1, 1 expansion, and Part 2: Cmin of itacitinib when administered in combination with corticosteroids
Minimum observed plasma or serum concentration over the dose interval.

Full Information

First Posted
June 29, 2018
Last Updated
October 20, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03584516
Brief Title
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Official Title
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
November 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-versus-host Disease
Keywords
Graft-versus-host-disease, itacitinib, Janus kinase inhibitor, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
In Part 2 of the study, participants in the placebo group will be allowed to cross over to the experimental group after completion of the primary analysis.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 : Dose determination of itacitinib
Arm Type
Experimental
Arm Description
itacitinib administered in combination with corticosteroids.
Arm Title
Part 1 : Dose expansion of itacitinib
Arm Type
Experimental
Arm Description
itacitinib administered in combination with corticosteroids or corticosteroids alone.
Arm Title
Part 2 : itacitinib recommended dose from part 1
Arm Type
Placebo Comparator
Arm Description
itacitinib or placebo administered in combination with corticosteroids
Intervention Type
Drug
Intervention Name(s)
Itacitinib
Other Intervention Name(s)
INCB039110
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
In Part 2, participants will receive matching placebo.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Medrol, Medrol Dosepak, Solu-Medrol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part 1 : Dose Determination: Number of dose-limiting toxicities
Description
To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
Time Frame
28 days
Title
Part 2 : Response rate
Description
Defined as the proportion of participants demonstrating a complete response (CR) or partial response (PR) per National Institutes of Health (NIH) consensus guideline.
Time Frame
Month 6
Title
Part 1 : Dose Expansion: Number of dose-limiting toxicities
Description
To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Part 1, 1 expansion, and Part 2: Cmax of itacitinib when administered in combination with corticosteroids
Description
Maximum observed concentration.
Time Frame
Up to 28 days
Title
Part 1, 1 expansion, and Part 2: Cmin of itacitinib when administered in combination with corticosteroids
Description
Minimum observed plasma or serum concentration over the dose interval.
Time Frame
Up to 28 days
Other Pre-specified Outcome Measures:
Title
Part 1, 1 expansion, and Part 2: Response rate
Description
Defined as the proportion of participants who demonstrate a CR or PR per NIH consensus guideline.
Time Frame
Up to 12 months
Title
Part 1: Time to response
Description
Defined as the interval between randomization and first response.
Time Frame
Up to 36 months
Title
Part 1, 1 expansion, and Part 2: Duration of response
Description
Defined as the interval between first response and cGVHD progression, death, malignancy relapse, or initiation of new systemic cGVHD therapy.
Time Frame
Up to 36 months
Title
Part 1, 1 expansion, and Part 2: Overall survival
Description
Defined as the interval between the date of randomization and the date of death due to any cause.
Time Frame
Up to 36 months
Title
Part 1, 1 expansion, and Part 2: Nonrelapse mortality
Description
Defined as the proportion of participants who died due to causes other than malignancy relapse.
Time Frame
Up to 36 months
Title
Part 2: Number of treatment-emergent adverse events
Description
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment).
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodica Morariu-Zamfir, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - Out Pt.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego Medical Center, Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University - Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Cancer Specialists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153-3328
Country
United States
Facility Name
Advocate Lutheran General Hospital - Oncology Specislists Sc
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60028
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5201
Country
United States
Facility Name
University of Kansas Hospital Authority
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2618
Country
United States
Facility Name
University of Maryland - Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Minnesota, Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-8550
Country
United States
Facility Name
University of Rochester, James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oncology Hematology Care, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
Country
United States
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Jefferson University Hospitals
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232-1309
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-2108
Country
United States
Facility Name
Tri Star Bone Marrow Transplant
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
St David'S South Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Ordensklinikum Linz Gmbh Elisabethinen
City
Linz
ZIP/Postal Code
04020
Country
Austria
Facility Name
Zna Stuivenberg
City
Antwerpen
ZIP/Postal Code
02060
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
01000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen (Uza)
City
Edegem
ZIP/Postal Code
02650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN
City
Liege
ZIP/Postal Code
04000
Country
Belgium
Facility Name
AZ DELTA
City
Roeselare
ZIP/Postal Code
08800
Country
Belgium
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hospital Maisonneuve Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Saskatchewan Cancer
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
The Finsen Centre National Hospital
City
Copenhagen
ZIP/Postal Code
02100
Country
Denmark
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Chu Amiens Picardie - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier D'Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Chu de Grenoble - Hopital Albert Michallon
City
Grenoble Cedex
ZIP/Postal Code
38700
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Chu de Nice - Hospital L Archet
City
Nice
ZIP/Postal Code
06800
Country
France
Facility Name
Chu de Rennes - Hospital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Chru Hopitaux de Tours Hospital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Hopitaux de Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitatsklinikum Bonn Aoer
City
Bonn
ZIP/Postal Code
00011
Country
Germany
Facility Name
University Clinic Carl Gustav Carus Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Erlangen - Medizinische Klinik 5
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
UNIVERSIT�TSKLINIKUM HALLE (SAALE)
City
Halle
ZIP/Postal Code
D06120
Country
Germany
Facility Name
University Medical Centre Hamburg-Eppendorf Centre of Oncology
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie
City
Leipzig
ZIP/Postal Code
00341
Country
Germany
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Universitaetsklinikum in Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Hospital of West Attica - Attikon
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
General Hospital of Thessaloniki G. Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center Ein Karem Hadassah
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petach Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv-yafo
ZIP/Postal Code
64239
Country
Israel
Facility Name
CLINICA DI EMATOLOGIA, UNIVERSIT� POLITECNICA DELLE MARCHE
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliera Papa Giovanni Xxiii
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione Irccs Ca Granda Ospedale Maggiore
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O.U. Di Modena - Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O.U. Federico Ii
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
City
Reggio Calabria
ZIP/Postal Code
89133
Country
Italy
Facility Name
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Irrcs Instituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
I.R.C.C.S. Casa Sollievo Della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Centro Ricerche Cliniche Di Verona (Crc)
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-592
Country
Poland
Facility Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Mtz Clinical Research Sp. Zo.O.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Institut Catala D Oncologia
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Ico Institut Catala D Oncologia
City
L'hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Son Espases University Hospital
City
Palma
ZIP/Postal Code
07120
Country
Spain
Facility Name
Clinica Universidad de Navarra (Cun)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinico de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Y Politcnico de La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Karolinska University Hospital Huddinge
City
Huddinge
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Skane University Hospital Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
08091
Country
Switzerland
Facility Name
Bristol Haematology & Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Barts Health Nhs Trust - St Bartholomews Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King'S College Hospital (Nhs Foundation)
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Nottingham University Hospitals Nhs Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
The Royal Marsden Nhs Foundation Trust - Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St. George'S University Hospitals Nhs Foundation Trust
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

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