Research
Treating GVHD with Four New Agents
Initial Systemic Treatment of Acute Graft-Versus-Host Disease
Protocol Description
The goal of this Phase II study is to define new agents with promising activity against acute graft-versus-host disease (GVHD). Four new drugs will be tested: etanercept, mycophenolate mofetil, ontak and pentostatin. Participants with newly diagnosed acute GVHD will be randomly assigned to receive corticosteroids plus one of the four new agents. Each agent will be assessed for safety and effectiveness. About 180 children will participate at up to 27 centers around the country, including approximately 12 participants at Children’s Hospital of Pittsburgh of UPMC.
Eligibility Criteria
Eligible candidates encompass boys and girls ages 2 and older with newly diagnosed acute GVHD.
Boys: 2 years and older
Girls: 2 years and older
Requirements
To address the risks of continued GVHD, four new drugs will be tested. Everyone in the study will be randomly assigned to receive prednisone or methylprednisolone plus weekly doses one of the four new drugs for the first eight weeks. Each participant will have an examination at week 4 and week 8, and other exams and blood tests will also be scheduled, as needed.
Visits: Up to 12
Duration: Up to 9 months
Status: Open for Enrollment
Source of Support
National Heart, Lung and Blood Institute
National Cancer Institute
Blood and Marrow Transplant Clinical Trials Network
Additional Resources
Study Description at National Institutes of Health
Primary Investigator(s)
Rakesh K. Goyal, MD
Contact Information
To get started, please contact:
Rakesh K. Goyal, MD
412-692-5055
