Clinical Trials | An Open Label, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination with Ruxolitinib in Patients with Myelofibrosis

The UVA Comprehensive Cancer Center is looking for adults 18 years and older who have intermediate-1, intermediate-2, or high-risk myelofibrosis to join a research study. The purpose of this study is to learn if a new drug called imetelstat, when used with ruxolitinib or other JAK inhibitors, is safe and helps people with myelofibrosis feel better. Researchers will also study if imetelstat causes any new side effects. You may be able to join the study if you have intermediate-1, intermediate-2, or high risk myelofibrosis and if you meet one of these criteria: • You have intermediate-1, intermediate-2, or high-risk myelofibrosis, and • Either you have never been treated with ruxolitinib or another JAK inhibitor, and your doctor thinks you can start imetelstat with one of these drugs, • Or you are already being treated with a JAK inhibitor and have been on it for at least 12 weeks. In this study, you will get a treatment drug and come in for visits. During these visits, you’ll have check-ups, lab tests, scans, blood draws, and talk with the study doctor. If you decide to join, the study has three parts: screening, treatment, and follow-up. First, during the screening, the study team will check if you qualify to join. If you do, you’ll start the treatment part, where you’ll get the study drug every 28 days. After your last dose, you’ll have a final visit within 30 days. Then, during the follow-up, the study team will contact you every 12 to 16 weeks to see how you’re doing. You won’t have to pay for the study drug, imetelstat, or for any visits or procedures that are part of the study. If you need medicine to help with common side effects, it may be given to you as part of regular care. Any regular medical care you get during the study like checkups or treatment for things like high blood pressure, diabetes, or heart problems will be billed to your insurance or to you, just like usual. Additional information can be found here: https://clinicaltrials.gov/study/NCT05371964 [email protected]