A Phase I Study of Brentuximab Vedotin for Acute Graft-vs-Host Disease that Persists Despite Steroids

Protocol
13-232
Full Title
Phase I Trial of Brentuximab Vedotin for Steroid Refractory Acute Graft-vs.-Host Disease (GVHD)
Phase
I
Purpose

Patients who have a stem cell transplant can experience a complication called graft-versus-host disease (GVHD), in which cells from the donor attack tissues of the recipient. Symptoms of GVHD include rash, digestive problems, weight loss, and liver dysfunction. GVHD is usually treated with steroid drugs (corticosteroids), but patients may experience symptoms during or after treatment. Steroids can also weaken the immune system.

Brentuximab vedotin is a drug used to treat some forms of lymphoma. It works by targeting a protein called CD30, which is also found on the surfaces of the white blood cells that cause acute GVHD. By killing these cells, brentuximab vedotin could be useful for treating acute GVHD.

In this study, researchers want to determine the highest dose of brentuximab vedotin that can be given safely in patients with acute GVHD that cannot be successfully treated with steroids.

Co-Investigators

Goldberg, Jenna, MD

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 stem cell transplantation and continue to experience GVHD symptoms despite steroid therapy.
  • This study is open to 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.

Disease(s)
Blood & Marrow Stem Cell Transplantation: Post-Transplant
Locations