A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
This study is for adults with a specific type of Myelodysplastic Syndrome (MDS) who have anaemia and need regular blood transfusions. Researchers want to compare a new medicine called Elritercept with a common treatment called Epoetin Alfa. The main goal is to see if Elritercept can help people need fewer red blood cell transfusions. They'll also look at how safe Elritercept is, if it helps reduce tiredness, and how it impacts overall quality of life, compared to Epoetin Alfa. Understanding how the body reacts to Elritercept is also part of the research. Your participation could help improve treatments for others with MDS.
At a glance
What is this study about?
This study is looking at a new medicine called Elritercept and comparing it to a standard treatment, Epoetin Alfa. It's for adults who have a condition called Myelodysplastic Syndrome (MDS) and often need blood transfusions because they have anaemia, which means they don't have enough healthy red blood cells.
The main thing researchers want to find out is if Elritercept can reduce how often people need blood transfusions. They will also be carefully checking how safe Elritercept is compared to Epoetin Alfa. This includes watching for any side effects or medical problems that might come up. In addition, the study will look at whether Elritercept can help people feel less tired, improve their quality of life, and reduce the overall burden of needing blood transfusions.
By taking part, you would be helping doctors and scientists learn more about how to treat MDS and anaemia more effectively. The information gathered from this study could lead to better treatments for people living with these conditions in the future.
Key takeaways
- This study compares a new medicine (Elritercept) with a standard one (Epoetin Alfa) for MDS and anaemia.
- It aims to see if Elritercept can reduce the need for blood transfusions.
- Researchers will also check for safety, tiredness levels, and quality of life.
- You must be an adult (18+) with a specific type of MDS and need regular blood transfusions.
- Participation involves regular visits and monitoring by the study team.
Who may be eligible?
To join this study, you need to be an adult aged 18 or over. You must have a diagnosis of Myelodysplastic Syndrome (MDS) that is considered very low, low, or intermediate risk by international standards. This will be checked by experts before you start.
You also need to be regularly receiving red blood cell transfusions due to your anaemia. Specifically, you would have needed between 2 and 6 units of blood every 8 weeks for at least the 8 weeks before the study starts. Your haemoglobin levels (a measure of red blood cells) would typically be 9.0 g/dL or lower when you receive a transfusion, often accompanied by symptoms of anaemia like tiredness or breathlessness.
Finally, some blood tests will be done to check your bone marrow and your natural levels of a hormone called erythropoietin (EPO). These tests help make sure the study medicine might be suitable for you. The study team will explain all these details clearly if you are interested.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of Myelodysplastic Syndrome (MDS) that your doctor says is 'very low', 'low', or 'intermediate' risk?
- Do you currently need regular red blood cell transfusions (typically 2-6 units every 8 weeks)?
- Have your doctors confirmed your MDS diagnosis with specific tests, including a bone marrow exam, and established your haemoglobin levels when you get transfusions?
- Are you willing and able to understand the study and give your permission (consent) to take part?
What does participation involve?
If you decide to join this study, you would first go through a screening process to make sure it's right for you. This involves several check-ups and blood tests. Once you're in the study, you would regularly receive either the new medicine, Elritercept, or the standard treatment, Epoetin Alfa. You wouldn't know which one you are getting, and neither would your study doctor, which helps make the results fair.
You'll have regular hospital visits for blood tests, physical exams, and to answer questions about how you're feeling and your quality of life. The doctors will closely monitor your blood counts, specifically your haemoglobin levels, and track any need for blood transfusions. You would also report any side effects or changes in your health. The total duration of your participation, including follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (146)
- Hematology-Oncology Medical Group of Orange County, Inc - Orange - 1010 W. La Veta AvenueVerified postcodeOrange, United States· Not yet recruiting
- BRCR Medical Center IncVerified postcodeTamarac, United States· Recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Not yet recruiting
- Orchard Healthcare Research Inc. (OHR) - SkokieVerified postcodeSkokie, United States· Recruiting
- Norton Cancer InstituteVerified postcodeLouisville, United States· Not yet recruiting
- American Oncology Partners P.A. MidAmerica Cancer CareVerified postcodeKansas City, United States· Not yet recruiting
- Albert Einstein College - MontefioreVerified postcodeThe Bronx, United States· Not yet recruiting
- Novant Health Care InstituteVerified postcodeWinston-Salem, United States· Not yet recruiting
- Cleveland clinic OHVerified postcodeCleveland, United States· Not yet recruiting
- Fox Chase Cancer CenterVerified postcodePhiladelphia, United States· Not yet recruiting
- Tennessee Oncology, PLLCVerified postcodeNashville, United States· Not yet recruiting
- Vanderbilt University Medical CenterVerified postcodeNashville, United States· Not yet recruiting
Common questions
What is Myelodysplastic Syndrome (MDS)?
MDS is a condition where your bone marrow doesn't make enough healthy blood cells. This can lead to problems like anaemia, where you don't have enough red blood cells.
What is anaemia and why do I need transfusions?
Anaemia means you have low red blood cells, which carry oxygen. When levels are too low, you feel tired and weak, and blood transfusions give you healthy red blood cells to help.
What are Elritercept and Epoetin Alfa?
Epoetin Alfa is a common medicine that helps your body make more red blood cells. Elritercept is a new medicine being tested to see if it works better or differently for people with MDS.
Will I feel better on this study?
The study aims to see if Elritercept improves tiredness and reduces the need for transfusions, but there's no guarantee. You will be closely monitored by doctors.
Can I stop participating in the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.
How to find out more
Takeda Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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