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

  • STATUS
    Recruiting
  • End date
    Apr 4, 2024
  • participants needed
    431
  • sponsor
    Incyte Corporation
Updated on 30 June 2021
platelet count
corticosteroids
prednisone
cell transplantation
neutrophil count

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).

Details
Condition Chronic Graft Versus Host Disease, chronic graft-versus-host disease
Treatment prednisone, Placebo, Methylprednisolone, itacitinib
Clinical Study IdentifierNCT03584516
SponsorIncyte Corporation
Last Modified on30 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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