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Acute Graft-Versus-Host Disease Treatment Study

Clinical Trial Title: 
A study of itacitinib or placebo in combination with corticosteroids for treatment of acute graft-versus-host disease.
Clinical Trial Protocol ID: 
17030905
Clinical Trial Investigator Name: 
Sunita Nathan, MD
Clinical Trial Protocol Description: 

Allogeneic bone marrow or hematopoietic stem cell transplant (HSCT) is an effective immunotherapy for human cancer.

There are 3 kinds of bone marrow or HSCTs:

  • Autologous bone marrow transplant: The prefix “auto” means self. Stem cells are removed from a patient before they receive high-dose chemotherapy or radiation treatment. The stem cells are stored in a freezer. After high-dose chemotherapy or radiation treatments, their stems cells are put back in their body to make normal blood cells.
  • Allogeneic bone marrow transplant: The prefix “allo” means other. Stem cells are removed from another person, called a donor. Most times, the donor's genes must at least partly match the patient’s genes. Special tests are done to see if a donor is a good match for the patient.
  • Umbilical cord blood transplant: This is a type of allogeneic transplant. Stem cells are removed from a newborn baby's umbilical cord right after birth. Umbilical cord blood cells are very immature so there is less of a need for perfect matching.

A stem cell transplant is usually done after chemotherapy and radiation is complete. When a patient receives a donor’s stem cells, the stem cells recreate the donor’s immune system in the patient’s body (“the host”).  A common side effect of allo-HSCTs is graft-versus-host disease (GVHD). It occurs when the new immune system from the donor attacks the host’s body. The donor cells see the host’s cells as “foreign” and attack them, which causes damage. There are two types of GVHD:

  • Acute GVHD (aGVHD): Develops in the first 100 days or so after the bone marrow transplant. This primarily affects the skin, stomach, intestines, and liver.
  • Chronic GVHD (cGVHD): Usually develops 3-6 months after the transplant, but signs can appear earlier or later.

The use of corticosteroids is generally recommended for first line treatment for aGVHD. But only 50% of aGVHD patients respond to systemic steroids, and many responses are not long lasting, so attempts are being made to add other agents to treatment with corticosteroids to provide longer lasting responses and fewer immunosuppression-related side effects.

Itacitinib is a potent and selective inhibitor of the Janus kinase (JAK) family of the protein tyrosine kinases (TYKs) with selectivity for JAK1. Inhibition of tyrosine kinases activity using small molecules has recently become a powerful tool for treatment of several malignancies.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are 18 years of age or older.
  • Have had 1 allo-HSCT from any donor and any donor source for a hematologic malignancy or disorder.
  • Have suspected Grade II to Grade IV aGVHD occurring after allo-HSCT and after any preventative GVHD treatment.
  • Are able to swallow and retain oral medication.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had more than 1 allo-HSCT.
  • Have received more than 2 days of systemic corticosteroids for aGVHD.
  • Have developed chronic GVHD.
  • Have received Janus kinase (JAK) inhibitor therapy after allo-HSCT for any indication.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-8892
Contact Name: 
Jean Gibson