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

Completed · Phase 3 · Has a placebo group

Conditions studied: Graft-versus-host Disease (GVHD)

In brief

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).

Key facts

Study ID

NCT03139604

Run by

Incyte Corporation

People needed

439

Starts

2017-07-19

Expected to finish

2020-07-13

Last updated by the study team

2025-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California, United States
• Stanford Cancer Center — Stanford, California, United States
• University of Colorado - Aurora Cancer Center — Aurora, Colorado, United States
• University of Florida (UF) - Division of Hematology & Oncology — Gainesville, Florida, United States
• University of Miami - Sylvester Cancer Center — Miami, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Advocate Lutheran General Hospital - Oncology Specialists SC — Park Ridge, Illinois, United States
• Indiana University (IU) Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Indiana Blood and Marrow Transplant — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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