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

Primary Purpose

Graft-versus-host Disease (GVHD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Itacitinib
Placebo
Prednisone
Methylprednisolone
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft-versus-host Disease (GVHD) focused on measuring Acute graft-versus-host disease, Janus kinase (JAK) inhibitor, itacitinib, corticosteroids, allogeneic hematopoietic stem cell transplant (allo-HSCT)

Eligibility Criteria

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

Inclusion Criteria:

  • Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • 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 1 allo-HSCT.
  • 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.

Sites / Locations

  • University of California, San Diego (UCSD) - Moores Cancer Center
  • University of Southern California
  • University of California, Los Angeles (UCLA) - Medical Center
  • Stanford Cancer Center
  • University of Colorado - Aurora Cancer Center
  • University of Florida (UF) - Division of Hematology & Oncology
  • University of Miami - Sylvester Cancer Center
  • Florida Hospital Cancer Institute
  • University of Illinois at Chicago
  • University of Chicago
  • Advocate Lutheran General Hospital - Oncology Specialists SC
  • Indiana University (IU) Melvin and Bren Simon Cancer Center
  • Indiana Blood and Marrow Transplant
  • University of Iowa
  • University of Kansas Cancer Center
  • Tulane University Medical Center
  • University of Maryland Medical Center
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • University of Michigan
  • Henry Ford Hospital
  • Spectrum Health
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • University of Nebraska Medical Center
  • Dartmouth Hitchcock Medical Center
  • John Theurer Cancer Center At Hackensack UMC
  • Rutgers Cancer Institute of New Jersey
  • Northwell Health
  • Columbia University
  • Memorial Sloan Kettering Cancer Center
  • Stony Brook University Medical Center
  • Levine Cancer Institute
  • Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
  • Oncology Hematology in Cincinnati
  • University Hospitals Cleveland Medical Center
  • The Ohio State University (OSU)
  • University of Oklahoma - Health Sciences Center
  • Oregon Health & Science University (OHSU)
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
  • Greenville Health System
  • Methodist Healthcare Foundation
  • Sarah Cannon Research Institute, LLC (SCRI)
  • Vanderbilt University Medical Center
  • Texas Transplant Institute
  • University of Virginia Medical Center
  • St Vincents Hospital Sydney Limited
  • Ordensklinikum Linz GmbH Elisabethinen
  • ZNA Stuivenberg
  • General Hospital Sint-Jan Brugge-Oostend
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Gent (UZG)
  • Jessa Ziekenhuis
  • Hopital universitaire du Sart Tilman de Liege
  • AZ Delta
  • UHKT Prague - Institute of Hematology and Blood Transfusion
  • Helsinki University Central Hospital
  • CHU Amiens Picardie - Hopital Sud
  • CHRU de Lille-Hopital Claude Huriez
  • Hotel Dieu Hospital - Hematologie
  • Hopital Saint Louis
  • Hopital Haut Leveque - CHU Bordeaux - Maladies du sang
  • Hopital de Hautepierre
  • Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol
  • CHU de Nancy
  • University Clinic Carl Gustav Carus, Technical University Dresden
  • Universitatsklinikum Freiburg - Klinik fur Innere Medizin I
  • Universitatsklinikum Hamburg - Eppendorf
  • Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)
  • Universitaetsklinikum Leipzig
  • Universitaetsmedizin der Johannes Gutenberg
  • UKGM Marburg Innere Medizin: Haematologie Onkolog
  • General Hospital of Thessaloniki G. Papanikolaou - Hematology Department
  • Rambam Health Care Campus
  • Hadassah Hebrew University Medical Center Ein Karem
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari
  • Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi
  • Azienda Ospedaliero Universitaria Careggi
  • ASST Grande Ospedale Metropolitano Niguarda
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
  • IRCCS Ospedale San Raffaele
  • Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza
  • Casa di Cura La Maddalena
  • Fondazione IRCCS Policlinco San Matteo
  • Presidio Ospedaliero Pescara
  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
  • Azienda Unità Sanitaria Locale di Reggio Emilia
  • University of Rome La Sapienza
  • Istituto Clinico Humanitas
  • A.O.U. Città della Salute e della Scienza di Torino
  • SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine
  • Seoul National University Hospital
  • Auckland District Health Board
  • Centrum Onkologii- Instytut w Gliwicach
  • Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii
  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)
  • Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
  • Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic i Provincial de Barcelona
  • Instituto Catalan de Oncologia - Hospital Duran i Reynals
  • Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitario de Salamanca
  • Hospital Universitario de Donostia
  • Hospital Universitario Marques de Valdecilla
  • Hospital Clinico de Santiago de Compostela
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario de Valencia
  • Hospital Universitari i Politecnic La Fe
  • Universtity Hospital Basel - Haematology
  • Hopitaux Universitaires de Geneve
  • Universitaetsspital Zuerich - Klinik fuer Haematology
  • China Medical University Hospital
  • Addenbrooke's Hospital
  • University Hospital of Wales
  • Hammersmith Hospital
  • Nottingham University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Itacitinib

Placebo

Arm Description

Itacitinib plus corticosteroids

Matching placebo plus corticosteroids

Outcomes

Primary Outcome Measures

Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).

Secondary Outcome Measures

Nonrelapse Mortality
Defined as the percentage of participants who died due to causes other than malignancy relapse.
Duration of Response
Defined as the interval from first response until GVHD progression or death.
Cmax of Itacitinib When Administered in Combination With Corticosteroids
Defined as maximum observed plasma concentration.
Cmin of Itacitinib When Administered in Combination With Corticosteroids
Defined as minimum observed plasma concentration.
Tmax of Itacitinib When Administered in Combination With Corticosteroids
Defined as time to maximum plasma concentration.
AUC of Itacitinib When Administered in Combination With Corticosteroids
Defined as area under the concentration-time curve.
CL/F of Itacitinib When Administered in Combination With Corticosteroids
Defined as oral dose clearance.
Time to Response
Defined as the interval from treatment initiation to first response
Relapse Rate of Malignant and Nonmalignant Hematologic Disease
Defined as the proportion of subjects whose underlying hematologic disease relapses
Malignancy Relapse-related Mortality Rate
Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.
Failure-free Survival
Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)
Overall Survival (OS)
Defined as the interval from study enrollment to death due to any cause.
Number of Treatment-emergent Adverse Events With INCB39110
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment
Incidence Rate of Secondary Graft Failure
Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion
Proportion of Subjects Who Discontinue Corticosteroids
Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated
Proportion of Subjects Who Discontinue Immunosuppressive Medications
Summary statistics of subjects discontinuing immunosuppressive medications will be calculated
Incidence Rate of aGVHD Flares
Incidence Rate of cGVHD
Objective Response Rate

Full Information

First Posted
May 2, 2017
Last Updated
July 13, 2021
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03139604
Brief Title
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Official Title
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
July 13, 2020 (Actual)

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-versus-host Disease (GVHD)
Keywords
Acute graft-versus-host disease, Janus kinase (JAK) inhibitor, itacitinib, corticosteroids, allogeneic hematopoietic stem cell transplant (allo-HSCT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Itacitinib
Arm Type
Experimental
Arm Description
Itacitinib plus corticosteroids
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo plus corticosteroids
Intervention Type
Drug
Intervention Name(s)
Itacitinib
Other Intervention Name(s)
INCB039110
Intervention Description
Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Deltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DS
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Medrol, Medrol Dosepak, Solu-Medrol
Intervention Description
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
Primary Outcome Measure Information:
Title
Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
Description
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Nonrelapse Mortality
Description
Defined as the percentage of participants who died due to causes other than malignancy relapse.
Time Frame
Month 6,9,12 and 24
Title
Duration of Response
Description
Defined as the interval from first response until GVHD progression or death.
Time Frame
Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months
Title
Cmax of Itacitinib When Administered in Combination With Corticosteroids
Description
Defined as maximum observed plasma concentration.
Time Frame
Protocol-defined timepoints up to Day 28
Title
Cmin of Itacitinib When Administered in Combination With Corticosteroids
Description
Defined as minimum observed plasma concentration.
Time Frame
Protocol-defined timepoints up to Day 28
Title
Tmax of Itacitinib When Administered in Combination With Corticosteroids
Description
Defined as time to maximum plasma concentration.
Time Frame
Protocol-defined timepoints up to Day 28
Title
AUC of Itacitinib When Administered in Combination With Corticosteroids
Description
Defined as area under the concentration-time curve.
Time Frame
Protocol-defined timepoints up to Day 28
Title
CL/F of Itacitinib When Administered in Combination With Corticosteroids
Description
Defined as oral dose clearance.
Time Frame
Protocol-defined timepoints up to Day 28
Title
Time to Response
Description
Defined as the interval from treatment initiation to first response
Time Frame
End of Study, total particpation expected to average 24 months
Title
Relapse Rate of Malignant and Nonmalignant Hematologic Disease
Description
Defined as the proportion of subjects whose underlying hematologic disease relapses
Time Frame
Randomization through end of Study, study duration expected to average 24 months
Title
Malignancy Relapse-related Mortality Rate
Description
Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.
Time Frame
Randomization through end of Study, study duration expected to average 24 months
Title
Failure-free Survival
Description
Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)
Time Frame
6 months from randomization
Title
Overall Survival (OS)
Description
Defined as the interval from study enrollment to death due to any cause.
Time Frame
End of Study up to approximately 24 months
Title
Number of Treatment-emergent Adverse Events With INCB39110
Description
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment
Time Frame
30-35 days after end of treatment, approximately 24 months
Title
Incidence Rate of Secondary Graft Failure
Description
Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion
Time Frame
Randomization through end of Study, study duration expected to average 24 months
Title
Proportion of Subjects Who Discontinue Corticosteroids
Description
Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated
Time Frame
Days 28, 56, 100, and 180
Title
Proportion of Subjects Who Discontinue Immunosuppressive Medications
Description
Summary statistics of subjects discontinuing immunosuppressive medications will be calculated
Time Frame
Days 56 and 100
Title
Incidence Rate of aGVHD Flares
Time Frame
up to day 100
Title
Incidence Rate of cGVHD
Time Frame
Days 180 and 365
Title
Objective Response Rate
Time Frame
Days 14, 56 and 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible. 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 1 allo-HSCT. 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.
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 California, San Diego (UCSD) - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles (UCLA) - Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1678
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado - Aurora Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida (UF) - Division of Hematology & Oncology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami - Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Lutheran General Hospital - Oncology Specialists SC
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60028
Country
United States
Facility Name
Indiana University (IU) Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Blood and Marrow Transplant
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical 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
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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 Hospital
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 Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
John Theurer Cancer Center At Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-2681
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest Baptist Medical Center - Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oncology Hematology in Cincinnati
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
Country
United States
Facility Name
The Ohio State University (OSU)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma - Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Methodist Healthcare Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Sarah Cannon Research Institute, LLC (SCRI)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
St Vincents Hospital Sydney Limited
City
Darlinghurst
ZIP/Postal Code
NSW 2010
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
General Hospital Sint-Jan Brugge-Oostend
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent (UZG)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Hopital universitaire du Sart Tilman de Liege
City
Liege 1
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
UHKT Prague - Institute of Hematology and Blood Transfusion
City
Praha 2
ZIP/Postal Code
128 20
Country
Czechia
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
CHU Amiens Picardie - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHRU de Lille-Hopital Claude Huriez
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hotel Dieu Hospital - Hematologie
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Haut Leveque - CHU Bordeaux - Maladies du sang
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital de Hautepierre
City
Strasbourg cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Nancy
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
University Clinic Carl Gustav Carus, Technical University Dresden
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Universitatsklinikum Freiburg - Klinik fur Innere Medizin I
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
UKGM Marburg Innere Medizin: Haematologie Onkolog
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
General Hospital of Thessaloniki G. Papanikolaou - Hematology Department
City
Chortiátis
ZIP/Postal Code
57010
Country
Greece
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Hebrew University Medical Center Ein Karem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262160
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari
City
Cagliari
ZIP/Postal Code
09126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Casa di Cura La Maddalena
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Fondazione IRCCS Policlinco San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Presidio Ospedaliero Pescara
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Azienda Unità Sanitaria Locale di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
University of Rome La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Auckland District Health Board
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Centrum Onkologii- Instytut w Gliwicach
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
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 Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario de Donostia
City
San Sebastián
ZIP/Postal Code
20014
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 Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universtity Hospital Basel - Haematology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Universitaetsspital Zuerich - Klinik fuer Haematology
City
Zuerich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447 ROC
Country
Taiwan
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35689489
Citation
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.
Results Reference
derived
PubMed Identifier
34971577
Citation
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.
Results Reference
derived

Learn more about this trial

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

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