Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a new pill tame GVHD after transplant?

NCT ID NCT03139604

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This large Phase 3 study tested whether adding the drug itacitinib to standard steroids helps control acute graft-versus-host disease (GVHD) in people who had a stem cell transplant for blood cancer. About 439 participants received either itacitinib or a placebo along with steroids. The main goal was to see if more people responded to treatment with itacitinib.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
itacitinib (a drug taken by mouth that blocks inflammation)
What this could lead to
If it works, this could offer a new first-line treatment option to better control acute graft-versus-host disease after a stem cell transplant.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely reported. The drug may not improve response rates over standard steroids alone, and side effects like infection risk are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

439 people

The number who actually took part.

Started

Jul 2017

Finished

Jul 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute-graft-versus-host disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft-versus-host disease(GVHD)

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • AZ Delta

    Roeselare, 8800, Belgium

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Advocate Lutheran General Hospital - Oncology Specialists SC

    Park Ridge, Illinois, 60028, United States

  • Auckland District Health Board

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

    Reggio Calabria, 89124, Italy

  • Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi

    Catania, 95124, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Azienda Unità Sanitaria Locale di Reggio Emilia

    Reggio Emilia, 42123, Italy

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari

    Cagliari, 09126, Italy

  • CHRU de Lille-Hopital Claude Huriez

    Lille, 59037, France

  • CHU Amiens Picardie - Hopital Sud

    Amiens, 80054, France

  • CHU de Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • Casa di Cura La Maddalena

    Palermo, 90146, Italy

  • Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Centrum Onkologii- Instytut w Gliwicach

    Gliwice, 44-101, Poland

  • Chaim Sheba Medical Center

    Ramat Gan, 5262160, Israel

  • China Medical University Hospital

    Taichung, 40447 ROC, Taiwan

  • Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza

    Monza, 20900, Italy

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Columbia University

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122, Italy

  • Fondazione IRCCS Policlinco San Matteo

    Pavia, 27100, Italy

  • General Hospital Sint-Jan Brugge-Oostend

    Bruges, 8000, Belgium

  • General Hospital of Thessaloniki G. Papanikolaou - Hematology Department

    Chortiatis, 57010, Greece

  • Greenville Health System

    Greenville, South Carolina, 29615, United States

  • Hadassah Hebrew University Medical Center Ein Karem

    Jerusalem, 9112001, Israel

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Helsinki University Central Hospital

    Helsinki, 00290, Finland

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hopital Haut Leveque - CHU Bordeaux - Maladies du sang

    Pessac, 33604, France

  • Hopital Saint Louis

    Paris, 75010, France

  • Hopital de Hautepierre

    Strasbourg, 67098, France

  • Hopital universitaire du Sart Tilman de Liege

    Liège, 4000, Belgium

  • Hopitaux Universitaires de Geneve

    Geneva, 1211, Switzerland

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clinico de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Donostia

    San Sebastián, 20014, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica

    Barcelona, 08025, Spain

  • Hotel Dieu Hospital - Hematologie

    Nantes, 44000, France

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Indiana Blood and Marrow Transplant

    Indianapolis, Indiana, 46237, United States

  • Indiana University (IU) Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol

    Toulouse, 31059, France

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Barcelona, 08907, Spain

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)

    Lisbon, 1099-023, Portugal

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072, Portugal

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • John Theurer Cancer Center At Hackensack UMC

    Hackensack, New Jersey, 07601, United States

  • Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Methodist Healthcare Foundation

    Memphis, Tennessee, 38104, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Nottingham University Hospitals

    Nottingham, NG5 1PB, United Kingdom

  • Oncology Hematology in Cincinnati

    Cincinnati, Ohio, 45236, United States

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020, Austria

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239-3098, United States

  • Presidio Ospedaliero Pescara

    Pescara, 65124, Italy

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903-2681, United States

  • SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine

    Udine, 33100, Italy

  • Sarah Cannon Research Institute, LLC (SCRI)

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St Vincents Hospital Sydney Limited

    Darlinghurst, NSW 2010, Australia

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Texas Transplant Institute

    San Antonio, Texas, 78229, United States

  • The Ohio State University (OSU)

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112, United States

  • UHKT Prague - Institute of Hematology and Blood Transfusion

    Prague, 128 20, Czechia

  • UKGM Marburg Innere Medizin: Haematologie Onkolog

    Marburg, 35043, Germany

  • Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)

    Cologne, 50924, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 4103, Germany

  • Universitaetsmedizin der Johannes Gutenberg

    Mainz, 55131, Germany

  • Universitaetsspital Zuerich - Klinik fuer Haematology

    Zurich, CH-8091, Switzerland

  • Universitair Ziekenhuis Gent (UZG)

    Ghent, 9000, Belgium

  • Universitatsklinikum Freiburg - Klinik fur Innere Medizin I

    Freiburg im Breisgau, 79106, Germany

  • Universitatsklinikum Hamburg - Eppendorf

    Hamburg, 20246, Germany

  • University Clinic Carl Gustav Carus, Technical University Dresden

    Dresden, 1307, Germany

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California, Los Angeles (UCLA) - Medical Center

    Los Angeles, California, 90095-1678, United States

  • University of California, San Diego (UCSD) - Moores Cancer Center

    La Jolla, California, 92093-0698, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado - Aurora Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Florida (UF) - Division of Hematology & Oncology

    Gainesville, Florida, 32610, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Miami - Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680, United States

  • University of Oklahoma - Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Rome La Sapienza

    Roma, 00161, Italy

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Universtity Hospital Basel - Haematology

    Basel, 4031, Switzerland

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Medical Center - Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • ZNA Stuivenberg

    Antwerp, 2060, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.