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

Incyte

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Acute Graft-versus-host Disease

Treatments

Drug: Itacitinib

Drug: Corticosteroids

Study type

Interventional

Funder types

Industry

Identifiers

NCT03721965

INCB 39110-120

2018-002253-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

28 days to 18 years old

Volunteers

No Healthy Volunteers

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.