Clinical Trials Using Baricitinib
Clinical trials are research studies that involve people. The clinical trials on this list are studying Baricitinib. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Study of Baricitinib, a JAK1 / 2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Background: Chronic graft versus host disease (cGVHD) can affect people who had a hematopoietic stem cell transplant using donor cells. It is often fatal. It is usually treated with high doses of steroids. But that helps only about half the people in the long term. Researchers want to see if a drug called baricitinib can help people with cGVHD that has not responded to therapy. The drug inhibits the proteins involved in communication in the immune system. These proteins may play a role in cGVHD and other inflammatory diseases. Objectives: To test the safety and effectiveness of baricitinib in people with cGVHD that has not responded to therapy. Eligibility: Adults 18 and older with cGVHD that has not responded to therapy. Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have lung and heart tests and chest scans. Baseline visit: Participants will have: Medical history Physical exam Blood tests Tests for infectious diseases Skin, eye, and teeth evaluations Rehabilitation and occupational medicine evaluations Photos of any lesions Gynecology evaluation (females) The study will occur in 28-day cycles. Participants will take the study drug by mouth every day for 3 cycles. Some will take it for 3 or 6 more cycles. Participants will have a few visits during each cycle. They will repeat some previous tests. They may also have scans and questionnaires. Participants will have a visit when they stop taking the drug and another 3 months later. They will repeat a few study tests. They will have follow-up calls for 2 years.
Location: National Institutes of Health Clinical Center, Bethesda, Maryland