Duarte, California 91010


Purpose:

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.


Criteria:

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.


NCT ID:

NCT03721965


Primary Contact:

Study Director
Rodica Morariu-Zamfir, MD
Incyte Corporation

Incyte Corporation Call Center (US)
Phone: 1.855.463.3463
Email: medinfo@incyte.com


Backup Contact:

Email: globalmedinfo@incyte.com
Incyte Corporation Call Center (ex-US)
Phone: +800 00027423


Location Contact:

Duarte, California 91010
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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