GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

• Status: Recruiting
• Trial end date: 2024-04-04
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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.