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New drug combo for transplant complication shows promise but study halted

NCT ID NCT03584516

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding itacitinib (an anti-inflammatory drug) to standard steroid treatment could help people with moderate to severe chronic graft-versus-host disease (cGVHD), a complication after stem cell transplants. The trial enrolled 155 participants but was terminated early, so the full results are not available. The goal was to see if the combination improved response rates and was safe.

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 targets inflammation)
What this could lead to
If successful, this could point toward a new first-line treatment option for chronic graft-versus-host disease, potentially improving outcomes for transplant patients.
What could go wrong
The study was terminated early, so results are limited. Itacitinib may not prove more effective than standard steroids alone, and side effects like infections or organ issues 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

155 people

The number who actually took part.

Started

Jan 2019

Finished

Nov 2023

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: * 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.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic 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.

Chronic graft versus host disease

Contacts and locations

Locations

  • A.O.U. Di Modena - Policlinico

    Modena, 41124, Italy

  • A.O.U. Federico Ii

    Naples, 80131, Italy

  • AZ DELTA

    Roeselare, 08800, Belgium

  • Advocate Lutheran General Hospital - Oncology Specislists Sc

    Park Ridge, Illinois, 60028, United States

  • Augusta University - Medical College of Georgia

    Augusta, Georgia, 30912, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-2108, United States

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

    Reggio Calabria, 89133, Italy

  • Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

    Palermo, 90100, Italy

  • Azienda Ospedaliera Papa Giovanni Xxiii

    Bergamo, 24127, Italy

  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

    Torino, 10126, Italy

  • Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia

    Udine, 33100, Italy

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Barts Health Nhs Trust - St Bartholomews Hospital

    London, EC1A 7BE, United Kingdom

  • Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED, United Kingdom

  • CENTRE HOSPITALIER UNIVERSITAIRE DE LI�GE - SART TILMAN

    Liège, 04000, Belgium

  • CLINICA DI EMATOLOGIA, UNIVERSIT� POLITECNICA DELLE MARCHE

    Ancona, 60126, Italy

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier D'Angers

    Angers, 49000, France

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44000, France

  • Centro Ricerche Cliniche Di Verona (Crc)

    Verona, 37134, Italy

  • Charite Berlin

    Berlin, 12200, Germany

  • Chru Hopitaux de Tours Hospital Bretonneau

    Tours, 37000, France

  • Chu Amiens Picardie - Hopital Sud

    Amiens, 80054, France

  • Chu de Grenoble - Hopital Albert Michallon

    Grenoble, 38700, France

  • Chu de Nice - Hospital L Archet

    Nice, 06800, France

  • Chu de Rennes - Hospital Pontchaillou

    Rennes, 35033, France

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008, Spain

  • Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

    Pavia, 27100, Italy

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • General Hospital of Thessaloniki G. Papanikolaou

    Thessaloniki, 57010, Greece

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-8550, United States

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120, Israel

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, 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 Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital Universitario Y Politcnico de La Fe

    Valencia, 46009, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • I.R.C.C.S. Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • Ico Institut Catala D Oncologia

    L'Hospitalet de Llobregat, 08908, Spain

  • Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen

    Munich, 81675, Germany

  • Illinois Cancer Specialists

    Chicago, Illinois, 60714, United States

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202-5201, United States

  • Institut Catala D Oncologia

    Badalona, 08916, Spain

  • Institut Jules Bordet

    Brussels, 01000, Belgium

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Irrcs Instituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milan, 20132, Italy

  • Jefferson University Hospitals

    Philadelphia, Pennsylvania, 19107, United States

  • Karolinska University Hospital Huddinge

    Huddinge, 141 86, Sweden

  • King'S College Hospital (Nhs Foundation)

    London, SE5 9RS, United Kingdom

  • L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI

    Bologna, 40138, Italy

  • Loyola University Medical Center

    Maywood, Illinois, 60153-3328, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mtz Clinical Research Sp. Zo.O.

    Warsaw, 02-106, Poland

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi

    Gliwice, 44-101, Poland

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG5 1PB, United Kingdom

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45236, United States

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 04020, Austria

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Roma, 00168, Italy

  • Rabin Medical Center - Beilinson Hospital

    Petach Tiqwa, 49100, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110, United States

  • Saskatchewan Cancer

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie

    Leipzig, 00341, Germany

  • Skane University Hospital Lund

    Lund, 22185, Sweden

  • Son Espases University Hospital

    Palma, 07120, Spain

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St David'S South Austin Medical Center

    Austin, Texas, 78704, United States

  • St. George'S University Hospitals Nhs Foundation Trust

    Tooting, SW17 0QT, United Kingdom

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Szpital Kliniczny Przemienienia Panskiego

    Poznan, 60-569, Poland

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230, United States

  • The Finsen Centre National Hospital

    Copenhagen, 02100, Denmark

  • The Royal Marsden Nhs Foundation Trust - Sutton

    Sutton, SM2 5PT, United Kingdom

  • Tri Star Bone Marrow Transplant

    Nashville, Tennessee, 37203, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1552, United States

  • Tulane University

    New Orleans, Louisiana, 70112-2618, United States

  • Turku University Hospital

    Turku, 20521, Finland

  • UNIVERSIT�TSKLINIKUM HALLE (SAALE)

    Halle, D06120, Germany

  • Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia

    Roma, 00161, Italy

  • Universitaetsklinikum Erlangen - Medizinische Klinik 5

    Erlangen, 91054, Germany

  • Universitaetsklinikum Jena

    Jena, 07740, Germany

  • Universitaetsklinikum in Tubingen

    Tübingen, 72076, Germany

  • Universitaetsmedizin Rostock

    Rostock, 18057, Germany

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 09000, Belgium

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000, Belgium

  • Universitatsklinikum Bonn Aoer

    Bonn, 00011, Germany

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • Universitatsklinikum Koln

    Cologne, 50937, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • Universitatsspital Zurich

    Zurich, 08091, Switzerland

  • University Clinic Carl Gustav Carus Technical University Dresden

    Dresden, 01307, Germany

  • University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital Mannheim

    Mannheim, 68167, Germany

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University Hospital of West Attica - Attikon

    Chaïdári, 124 62, Greece

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-1716, United States

  • University Medical Centre Hamburg-Eppendorf Centre of Oncology

    Hamburg, 20246, Germany

  • University of Alberta

    Edmonton, Alberta, T6G 2P4, Canada

  • University of Arizona Cancer Center - Out Pt.

    Tucson, Arizona, 85724, United States

  • University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205, United States

  • University of California San Diego Medical Center, Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of Kansas Hospital Authority

    Westwood, Kansas, 66160, United States

  • University of Maryland - Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136-1002, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota, Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232-1309, United States

  • University of Rochester, James P. Wilmot Cancer Center

    Rochester, New York, 14642-0001, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-592, Poland

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

  • Zna Stuivenberg

    Antwerp, 02060, Belgium

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