GRAVITAS-309: A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

  • STATUS
    Recruiting
Updated on 25 August 2021
graft versus host disease
graft-versus-host disease

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).

 

Description

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Details
Condition Graft-Versus-Host Disease (GVHD)
Clinical Study IdentifierTX218055
Last Modified on25 August 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) from any donor human leukocyte antigen (HLA) type (matched-related, matched-unrelated, or mismatched related or unrelated donor) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative or reduced intensity conditioning are eligible
Karnofsky Performance Status score ≥ 60%
Evidence of myeloid and platelet engraftment (ie, absolute neutrophil count ≥ 1.0 × 10^9/L and platelet count ≥ 25 × 10^9/L)
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 and concomitant use of calcineurin inhibitors as well as topical/inhaled steroids is acceptable
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. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible
Evidence of relapsed primary malignancy or receipt of treatment for relapse after the allo-HCT was performed
Corticosteroid therapy at doses > 0.25 mg/kg per day methylprednisolone or equivalent within 7 days of randomization
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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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