A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
This research study is investigating a new medication called elritercept for adults living with Myelodysplastic Syndromes (MDS). MDS is a type of blood disorder where the bone marrow doesn't make enough healthy blood cells. Many people with MDS also have anaemia, which is a common problem where you don't have enough red blood cells. The main goal of this study is to find out how safe elritercept is and how well people with lower-risk MDS and anaemia tolerate different doses of the medicine. We also want to see if elritercept can help the body produce more healthy red blood cells, which could improve anaemia. We'll also be carefully checking if anyone's MDS gets worse during the study. This is a Phase 2 study, meaning it's an early-stage trial focusing on safety and initial effectiveness.
At a glance
What is this study about?
Myelodysplastic Syndromes, or MDS, are a group of conditions where the bone marrow (the spongy material inside your bones that makes blood cells) doesn't work properly. This means the body might not make enough healthy red blood cells, white blood cells, or platelets. When there aren't enough healthy red blood cells, it's called anaemia, which can make you feel very tired, weak, and short of breath. This study is focusing on adults with lower-risk MDS who have anaemia.
The new medicine being tested is called elritercept. We believe it might work by helping your bone marrow produce more healthy red blood cells. In this study, we want to understand how safe elritercept is and if it helps improve the anaemia linked to MDS. We'll be looking carefully at any side effects people might have and how well they get on with the treatment, especially at different dose levels. We also want to know if the medicine helps the body make more healthy red blood cells, which could reduce the need for blood transfusions.
This study is important because anaemia in people with MDS can significantly affect their quality of life. Finding new and better ways to manage anaemia could make a real difference. We are also monitoring participants closely to ensure their MDS condition doesn't worsen during the study. This research helps us learn more about elritercept and its potential to help people with MDS.
Key takeaways
- This study is testing a new medicine, elritercept, for anaemia in adults with lower-risk MDS.
- The main goals are to check safety, how well people tolerate the medicine, and if it helps produce more red blood cells.
- Eligible participants are adults aged 18+ with certain types of lower-risk MDS and anaemia.
- Participation involves regular clinic visits, blood tests, and receiving the study medicine.
- You can stop participating in the study at any time, for any reason.
Who may be eligible?
This study is looking for adults aged 18 or over. You must have a diagnosis of Myelodysplastic Syndromes (MDS) that doctors consider to be either 'very low', 'low', or 'intermediate' risk. This means your MDS is not considered high-risk or aggressive.
You also need to have anaemia, which means you don't have enough red blood cells. This anaemia might be because you haven't recently had a blood transfusion and your haemoglobin (a measure of red blood cells) is low, or because you regularly need blood transfusions to keep your haemoglobin levels up. Your bone marrow, where blood cells are made, should have less than 5% immature cells (blasts).
Other important points for joining include being well enough overall to take part in the study activities and, if you are a woman who could get pregnant or a man who is sexually active, you must agree to use effective contraception during the study. The study team will check all these details with you carefully.
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 Syndromes (MDS) that doctors consider 'very low', 'low', or 'intermediate' risk?
- Do you have anaemia (low red blood cell count)?
- Are you able to attend regular clinic appointments and follow study instructions?
- If you are a woman who could get pregnant, are you willing to use effective contraception during the study?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, elritercept. The study is divided into different 'parts'. In the first part, you will receive treatment for 4 cycles. Each cycle is likely to involve regular visits to the clinic for check-ups, blood tests, and to receive your medication.
After completing the first part, if you meet certain criteria and tolerated the medicine well, you might be able to continue on in an 'extension' part of the study, which means staying on the medication for longer. Throughout the study, doctors and nurses will monitor your health closely, including your blood counts, how you are feeling, and any side effects you might experience. They will also do tests to see how your MDS is progressing and if the treatment is helping your anaemia. The total length of your participation will depend on the part of the study you are in, but the initial treatment period is 4 cycles.
Potential risks and benefits
Locations (47)
- City of Hope National Medical CenterVerified postcodeDuarte, United States· Recruiting
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC)Verified postcodeMiami, United States· Recruiting
- H. Lee Moffitt Cancer Center and Research CenterVerified postcodeTampa, United States· Recruiting
- Karmanos Cancer Institute at Mclaren Greater LansingVerified postcodeLansing, United States· Completed
- University of Pittsburgh Medical Health CenterVerified postcodePittsburgh, United States· Completed
- Border Medical Oncology ResearchVerified postcodeAlbury, Australia· Recruiting
- Tweed HospitalVerified postcodeTweed Heads, Australia· Recruiting
- Westmead HospitalVerified postcodeWestmead, Australia· Recruiting
- Townsville University HospitalVerified postcodeDouglas, Australia· Completed
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Recruiting
- Flinders Medical CentreVerified postcodeBedford Park, Australia· Recruiting
- Boxhill HospitalVerified postcodeBox Hill, Australia· Recruiting
Common questions
What is MDS and how does it relate to anaemia?
MDS is a condition where your bone marrow doesn't make enough healthy blood cells. This often leads to anaemia, which is when you don't have enough healthy red blood cells, causing tiredness and weakness.
What is elritercept?
Elritercept is the new medicine being tested in this study. It's designed to help your body produce more healthy red blood cells.
What are the main goals of this study?
The study aims to understand how safe elritercept is, how well people tolerate it, and if it helps improve anaemia in adults with lower-risk MDS.
Will I need to have blood transfusions during the study?
This study is for people with anaemia due to MDS, some of whom may already need transfusions. The aim is to see if elritercept can help reduce the need for them, but transfusions may still be necessary, depending on your condition.
Is this medicine available to everyone?
No, elritercept is an investigational medicine, meaning it's still being studied and is not yet available outside of clinical trials.
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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