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



Status:Not yet recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 17
Updated:10/28/2018
Start Date:December 1, 2018
End Date:November 10, 2022
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects

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.


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.
We found this trial at
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1100 Fairview Avenue North
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1500 East Duarte Road
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City of Hope National Medical Center City of Hope is dedicated to making a difference...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Miami, Florida 33155
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Minneapolis, Minnesota 55455
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Paris, 75019
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Wilmington, Delaware 19803
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