Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Graft-versus-host Disease

In brief

The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.

Key facts

Study ID

NCT03721965

Run by

Incyte Corporation

People needed

2

Starts

2019-12-31

Expected to finish

2020-02-17

Last updated by the study team

2025-11-04

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Children's Hospital Colorado - Center for Cancer and Blood Disorders — Aurora, Colorado, United States
• Nemours/A.I. duPont Hospital for Children — Wilmington, Delaware, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Doernbecher Children's Hospital - Division of Pediatric Hematology — Portland, Oregon, United States
• Children's Hospital of Philadelphia - Center for Childhood Cancer Research — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute, LLC — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Centre Hospitalier Universitaire de Rennes — Rennes, Cedex 2, France
• Hopitaux Universitaires De Strasbourg — Strasbourg, Cedex, France
• CHU de Grenoble — Grenoble, France
• CHU de Grenoble — Grenoble, France
• Robert Debre Hospital — Paris, France
• Hopitaux Universitaires De Strasbourg — Strasbourg, France
• CHRU Nancy — Vandœuvre-lès-Nancy, France
• CHU Nancy — Vandœuvre-lès-Nancy, France
• Universitaetsklinikum Aachen, AoeR — Aachen, Germany
• Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin — Jena, Germany
• Policlinico S. Orsola-Malpighi — Bologna, Italy

Full record on ClinicalTrials.gov

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