Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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).
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
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.