A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Purpose

The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Inclusion Criteria:

  • Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.
  • Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
  • Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation.
  • Willing to avoid pregnancy or fathering children.
  • Able to give written informed consent and comply with all study visits and procedures.
  • Able to swallow and retain oral medication.

Exclusion Criteria:

  • Has received more than 1 allo-HSCT.
  • Has received more than 2 days of systemic corticosteroids for aGVHD.
  • Presence of GVHD overlap syndrome.
  • Presence of an active uncontrolled infection.
  • Known human immunodeficiency virus infection.
  • Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
  • Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
  • Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
  • Severe organ dysfunction unrelated to underlying GVHD, including:

  • Cholestatic disorders or unresolved veno-occlusive disease of the liver.

  • Clinically significant or uncontrolled cardiac disease.

  • Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.

  • Currently breast feeding.
  • Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
  • Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
  • Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Keywords

cancer, Graft-versus-host disease, GRAVITAS-301

Principal Investigator

Nosha Farhadfar, M.D.

Department

MD-HEMATOLOGY/ONCOLOGY

Contact Information

Nosha.Farhadfar@medicine.ufl.edu

352-274-8506


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