Clinical Trials | MCC23051: A Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease (cGVHD) Needing Systemic Therapy
A phase II randomized study of Ruxolitinib vs prednisone as first-line therapy for chronic graft vs host disease (cGVHD) needing systemic therapy
The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with chronic graft versus host disease (cGvHD). The purpose of this research study is to find out if a medicine called Ruxolitinib works better than than prednisone, which is the current standard of care, for the initial treatment for people who have cGvHD. To do this, you will be randomly assigned (like flipping a coin) to receive either Ruxolitinib or prednisone. You have an equal chance of being randomized to receive either Ruxolitinib or prednisone. Both you and the study doctor will know which study drug you are receiving. The study involves taking either the drug Ruxolitinib or the drug prednisone for 6 cycles, with option to continue for a total of 24 cycles. You will also have the following procedures for research purposes: - Informed Consent / Review of Study Eligibility / Medical Records Review - Pulmonary (lung) function tests (PFTs) - Blood Tests - Take an experimental drug (Ruxolitinib) or a drug used in standard of care (prednisone) - Complete the study drug diary - Evaluation of any side effects you're experiencing - Pregnancy test - Hepatitis B, Hepatitis C, and HIV testing - Research questionnaires - Research blood samples Participation in this study could last for up to 2 ½ years. Study-related experimental medication, exams, and tests provided at no cost. Additional information found here: https://clinicaltrials.gov/study/ NCT06660355 For questions, contact: [email protected]