Clinical Trial Clinical Trial: A type of research study that tests how a drug, medical device, or treatment approach works in people. There are several types of clinical trials. Treatment trials test new treatment options. Diagnostic trials test new ways to diagnose a disease. Screening trials test the best way to detect a disease or health problem. Quality of life (supportive care) trials study ways to improve the comfort of people with chronic illness. Prevention trials look for better ways to prevent disease in people who have never had the disease. Trials are in four phases. Phase I tests a new drug or treatment in a small group to see if it is safe. Phase II expands the study to a larger group of people to find out if it works. Phase III expands the study to an even larger group of people to compare it to the standard treatment for the disease; and Phase IV takes place after the drug or treatment has been licensed and marketed to find out the long-term impact of the new treatment. If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the trial sponsor.
The primary goal of this RENEW study is to find out how well elritercept works in lowering the need for red blood cell red blood cell: The most numerous type of blood cell in healthy people. Red blood cells contain hemoglobin, a protein that picks up oxygen in the lungs and brings it to cells in all parts of the body. Also called erythrocyte, RBC. (RBC) transfusions. Other aims are to learn how well elitercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
- Over 18 years of age
- Diagnosed with very low-, low-, or intermediate-risk MDS with transfusion-dependent anemia anemia: (uh-NEE-mee-uh) A condition in which there is a shortage of red blood cells in the bloodstream. This causes a low red blood cell count. Symptoms of anemia are fatigue and tiredness.
- Refractory Refractory: Not responsive to treatment or cure. For example, refractory anemia is a low red blood cell count that doesn't respond to standard treatments. or intolerant to prior erythropoiesis-stimulating agents (ESA)
- Does not have del(5q) MDS, secondary MDS secondary MDS: A type of MDS that is caused by a previous treatment foranother another disorder or disease. Treatments typically associated with secondary MDS include radiation therapy and chemotherapy used to treat cancer. Also called therapy-related MDS, T-MDS. , or AML
- No prior use of TGF-β modulating therapy, hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide lenalidomide: Lenalidomide is a capsule that is taken by mouth. It is approved for treating low-risk, transfusion-dependent myelodysplastic syndrome (MDS) patients with an abnormality of chromosome 5q. It is currently in clinical trials to test its efficacy with a broader range of MDS patients. For some MDS… , imetelstat imetelstat: Who should not take RYTELO? Before taking RYTELO, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. RYTELO may harm your unborn baby and may cause loss of pregnancy. Tell your healthcare provider right away if you… , or immunosuppressive therapy immunosuppressive therapy: Immunosuppressive drug therapy lowers your body's immune response. This prevents your immune system from attacking your bone marrow, allowing bone marrow stem cells to grow, which raises blood counts. For older patients with acquired aplastic anemia, immunosuppressive drug therapy is the… given for treatment of MDS
- Have not previously received luspatercept (Reblozyl®)
- Del(5q) MDS or therapy-related (secondary) MDS.
- Anemia Anemia: (uh-NEE-mee-uh) A condition in which there is a shortage of red blood cells in the bloodstream. This causes a low red blood cell count. Symptoms of anemia are fatigue and tiredness. due to any other known cause (e.g., thalassemia, hemolytic anemia hemolytic anemia: Anemia due primarily to the excessive hemolysis or destruction of red blood cells , bleeding events, or deficiency of iron, B12, and/or folate folate: (FOE-late) A B-vitamin that is found in fresh or lightly cooked green vegetables. It helps the bone marrow make normal blood cells. Most people get enough folate in their diet. Doctors may have people with paroxysmal nocturnal hemaglobinuria (PNH) take a man-made form of folate called folic acid. ).
- Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.