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GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Trial Status: administratively complete
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).
Inclusion Criteria
Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03584516.
