Duarte, California 91010

  • host Disease

Purpose:

The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).


Criteria:

Inclusion Criteria: - Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria - Underwent allogeneic stem cell transplantation (allo-HCT) - Karnofsky Performance Status score ≥ 60%. - Evidence of myeloid and platelet engraftment. - Willingness to avoid pregnancy or fathering children based on protocol-defined criteria. Exclusion Criteria: - Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD. - Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP). - Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization. - cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. - Evidence of relapsed primary malignancy.


NCT ID:

NCT03584516


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

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 31, 2021

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