Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Keywords

Chronic Graft-versus-host Disease Graft-versus-host-disease itacitinib Janus kinase inhibitor corticosteroids Graft vs Host Disease Prednisone Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego Medical Center, Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03584516
Phase
Phase 2/3
Study Type
Interventional
Last Updated