A Phase II Study of Natalizumab plus Standard Steroid Treatment for High-Risk Graft-versus-Host Disease

Full Title

GCO 15-1624: Phase II Multicenter Study of Natalizumab plus Standard Steroid Treatment for High Risk 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. Steroid drugs are typically used to treat acute GVHD, but they are not always effective. In this study, researchers are evaluating the effectiveness of giving the drug natalizumab in combination with steroids to patients with newly diagnosed acute GVHD who have a high risk of not responding to steroid therapy alone.

GVHD is particularly serious when its affects the intestines. Natalizumab is already used to treat an inflammatory bowel disease called Crohn’s disease. Because it blocks the signals that cause donor T cells to travel to the digestive organs, it is thought that natalizumab may be helpful for reducing the risk of intestinal GVHD. Natalizumab is given intravenously (by vein).

Eligibility

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

  • Patients must have acute GVHD after receiving a stem cell transplant from a donor.
  • Researchers will use the “Ann Arbor scoring system” to predict a patient’s risk of not responding to steroids; patients must have an Ann Arbor score of 3 or higher to participate in this study.
  • Patients may not have had more than three days of steroid treatment before entering the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Doris Ponce at 212-639-4838 or ponced@mskcc.org.

Protocol

17-231

Phase

II

Investigator

Co-Investigators