GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

  • Interventional
  • Not Recruiting
  • NCT03139604
Eligibility Details Visit Clinicaltrials.gov

GRAVITAS-301: 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

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03139604

IRB#IRB17-0475

Lead SponsorIncyte Corporation

Lead PhysicianSatyajit Kosuri

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting