A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
This research study is looking at a new treatment called INCA033989 for a blood condition called essential thrombocythemia (ET). ET causes your body to make too many platelets, which are tiny blood cells that help stop bleeding. The study aims to compare INCA033989 with treatments that doctors currently use, known as 'best available therapy.' We want to find out if this new medicine is safe and effective for people with ET who have a specific gene change called a CALR mutation and have already received other treatments for their condition. The study is in Phase 3, meaning it's one of the final steps before a new medicine might be approved for wider use. It's an important step in finding better ways to manage ET.
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¿De qué trata este estudio?
This study is about finding better ways to help people with a condition called essential thrombocythemia, often shortened to ET. ET is a long-term blood disorder where your body produces too many platelets. Platelets are important for clotting blood, but having too many can lead to problems like unusual bleeding or blood clots.
The main goal of this study is to compare a new medicine, called INCA033989, with the treatments that doctors currently consider the best options for ET. These current treatments are called 'best available therapy.' The study focuses on people who have a specific genetic change, known as a CALR mutation, which is often found in ET. Participants in this study will have already tried other medicines for their ET.
By comparing the new medicine with existing treatments, researchers hope to learn if INCA033989 is more effective at managing ET symptoms, reducing risks, and improving the overall health of patients. This is a 'Phase 3' study, which means it's a large and important step in determining if the new medicine could eventually become a standard treatment for ET.
Puntos clave
- This study is testing a new medicine (INCA033989) for essential thrombocythemia (ET).
- It's for people with a CALR gene change who've already tried other ET treatments.
- The study compares the new medicine to standard 'best available' treatments.
- It aims to see if INCA033989 is a safe and effective new option for ET patients.
- Participation involves regular clinic visits and close health monitoring.
¿Quién puede ser elegible?
To join this study, you would first need to have a confirmed diagnosis of essential thrombocythemia (ET) that doctors consider 'high-risk.' This means your ET has certain features that make it more likely to cause complications. You also need to have a specific genetic change called a CALR mutation. This mutation will be checked if you don't already know if you have it. Additionally, you must have already tried at least one other medicine to help lower your platelet count (this is called cytoreductive therapy).
There are also some reasons why you might not be able to join. For example, if you have any other type of blood cancer apart from ET, or if you've had major bleeding or a serious blood clot in the last three months. You also can't have had a stem cell transplant in the past.
Other reasons for not being able to join include if you still have serious side effects (Grade 2 or worse) from previous treatments, unless these are long-term, stable issues not expected to get better, like some nerve problems. If you've had certain other cancers in the past, you might not be eligible unless they were successfully treated more than two years ago and show no signs of returning. The study team will review your full medical history to make sure the study is right for you.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Do I have a confirmed diagnosis of high-risk essential thrombocythemia (ET)?
- Have I been told I have a CALR gene mutation?
- Have I already taken at least one medicine to lower my platelet count (cytoreductive therapy)?
- Have I had any other blood cancers or recent serious bleeding/clots?
- Have I had a stem cell transplant before?
- Are any side effects from my previous treatments still serious?
¿En qué consiste la participación?
If you decide to take part in this study, you will be assigned to receive either the new medicine, INCA033989, or one of the 'best available therapies' that your doctor would normally prescribe for your condition. This will be decided by chance, like flipping a coin. You will have regular visits to the study clinic for check-ups, blood tests, and other assessments to monitor your health and how well the treatment is working. These visits will help doctors understand any changes in your condition and to watch for any side effects. You will be taking the study medication for a certain period, and there will be follow-up appointments even after you stop taking the medicine to continue monitoring your health. The total time you would be involved in the study, including follow-up, will be explained by the study team, but typically clinical trials can last for several months or even a few years.
Riesgos y beneficios potenciales
Locations (193)
- University of Alabama At Birmingham Comprehensive Cancer CenterCódigo postal verificadoBirmingham, United States· Aún no reclutando
- Banner Md Anderson Cancer CenterCódigo postal verificadoGilbert, United States· Aún no reclutando
- City of Hope Medical CenterCódigo postal verificadoDuarte, Estados Unidos· Reclutamiento
- Marin Cancer CareCódigo postal verificadoGreenbrae, United States· Reclutamiento
- University of California, San Diego-Moores Cancer CenterCódigo postal verificadoLa Jolla, Estados Unidos· Aún no reclutando
- University of California, Los Angeles Medical CenterCódigo postal verificadoLos Angeles, United States· Aún no reclutando
- Stanford Cancer CenterCódigo postal verificadoPalo Alto, Estados Unidos· Aún no reclutando
- Rocky Mountain Cancer Centers-Lone TreeCódigo postal verificadoLone Tree, United States· Aún no reclutando
- Medstar Georgetown Medical Center, IncCódigo postal verificadoWashington D.C., Estados Unidos· Aún no reclutando
- Florida Cancer Specialists & Research InstituteCódigo postal verificadoFort Myers, United States· Aún no reclutando
- University of Miami Sylvester Comprehensive Cancer CenterCódigo postal verificadoMiami, United States· Aún no reclutando
- Cleveland ClinicCódigo postal verificadoWeston, United States· Aún no reclutando
Preguntas comunes
What is essential thrombocythemia (ET)?
ET is a blood condition where your body makes too many platelets, which are cells that help your blood clot. This can lead to problems with bleeding or blood clots.
What is a CALR mutation?
It's a specific change in your genes that is often found in people with ET. The study is specifically looking at patients who have this mutation.
What does 'cytoreductive therapy' mean?
This is a type of medicine or treatment that helps to reduce the number of blood cells, in this case, platelets, in your body.
What does 'Phase 3' mean for a study?
Phase 3 means this is one of the final and largest stages of testing a new medicine. It compares the new treatment with existing ones to see if it's safe and effective before it can be approved for wider use.
Will I know which treatment I'm receiving?
In some studies like this one, participants are randomly assigned to a treatment group, and often neither you nor your study doctor will know which treatment you are receiving (this is called 'blinding'). This helps ensure the results are fair.
Cómo obtener más información
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