A Phase III Study of Itacitinib or Placebo plus Corticosteroids to Treat Acute Graft-Versus-Host Disease

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Full Title

INCB 39110-301: 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

Purpose

Graft-versus-host disease (GVHD) is a potential complication that can occur when someone receives stem cells from a donor. It happens when white blood cells called T cells from the donor attack the tissues of the patient. Acute GVHD occurs shortly after the transplant, usually within three months. Patients with acute GVHD usually receive treatment with corticosteroids, such as prednisone or methylprednisolone.

In this study, researchers want to see if adding the investigational drug itacitinib to corticosteroid treatment in people with acute GVHD is more effective than corticosteroids alone. Itacitinib stops the activity of a family of enzymes called JAK (janus kinases). It blocks their ability to signal and can alter certain immune responses. Some studies suggest that itacitinib may reduce GVHD.

Patients in this study will be randomly assigned to receive corticosteroids with itacitinib or a placebo (inactive drug). All of the medications used in this study are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in this study must have acute GVHD after receiving a donated (allogeneic) stem cell transplant as treatment for a blood cancer or blood disorder.
  • Patients may not have received more than one allogeneic stem cell transplant nor more than two days of prior corticosteroid therapy.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Miguel-Angel Perales at 212-639-8682.

Protocol

18-127

Phase

III

Investigator

Co-Investigators