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Pediatric GVHD drug combo trial halted early after just 2 kids enrolled

NCT ID NCT03721965

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a drug called itacitinib combined with steroids to treat acute graft-versus-host disease (aGVHD) in children. aGVHD is a serious complication where donor immune cells attack the child's body after a stem cell transplant. The trial was stopped early after enrolling only 2 participants, so we have very limited information on safety or effectiveness.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

2 people

The number who actually took part.

Started

Dec 2019

Finished

Feb 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

28 days to 18 years

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: * Male and female participants: 12 to \< 18 years old (Cohort 1), 6 to \< 12 years old (Cohort 2), 2 to \< 6 years old (Cohort 3), Weighing \> 8 kg to \< 2 years old (Cohort 4), and 28 days old to weighing ≤ 8 kg (Cohort 5). * Undergone 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor and source for hematological malignancies or disorders. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible. * Clinically suspected Grade II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any GVHD prophylactic medication. * Evidence of myeloid engraftment. Exclusion Criteria: * More than 1 allo-HSCT. * Received more than 2 days of systemic corticosteroids for aGVHD before the first study drug administration. * Presence of GVHD overlap syndrome. * Presence of an active uncontrolled infection. * Known HIV infection. * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. * Evidence of relapsed primary disease or have been treated for relapse after the allo-HSCT was performed. * Any corticosteroid therapy for indications other than GVHD at doses \> 1 mg/kg once daily of methylprednisolone (or equivalent) within 7 days of the first study drug administration. * Receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study. * Receipt of JAK inhibitor therapy after allo-HSCT for any indication. * Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease

As listed by the trial registrant

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

Acute-graft-versus-host disease

Contacts and locations

Locations

  • AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

    Torino, 10126, Italy

  • Azienda Ospedaliero Unversitatia Policlinico - Vittorio Emanuele - Presido Ospedaliero G. Rodolico

    Catania, 95123, Italy

  • Birmingham Childrens Hospital

    Birmingham, B4 6NH, United Kingdom

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ, United Kingdom

  • CHRU Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • CHU Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Grenoble

    Grenoble, 38403, France

  • Central Manchester University Hospital - Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Centre Hospitalier Universitaire de Rennes

    Rennes, Cedex 2, 35203, France

  • Children's Hospital Colorado - Center for Cancer and Blood Disorders

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia - Center for Childhood Cancer Research

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Hospital of Orange County

    Orange, California, 92868, United States

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Doernbecher Children's Hospital - Division of Pediatric Hematology

    Portland, Oregon, 97239, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fondazione MBBM

    Monza, 20900, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024, United States

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH, United Kingdom

  • Hopitaux Universitaires De Strasbourg

    Strasbourg, Cedex, 67098, France

  • Hopitaux Universitaires De Strasbourg

    Strasbourg, 67098, France

  • Hospital Clinico de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Vall D Hebron

    Barcelona, 08035, Spain

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS13EX, United Kingdom

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nemours/A.I. duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • Robert Debre Hospital

    Paris, 75019, France

  • Royal Marsden Hospital - Surrey

    Surrey Quays, SM2 5PT, United Kingdom

  • Sarah Cannon Research Institute, LLC

    Nashville, Tennessee, 37203, United States

  • Universitaetsklinikum Aachen, AoeR

    Aachen, 52074, Germany

  • Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin

    Jena, 07747, Germany

  • University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55454, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-6868, United States

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