A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib
This important study is designed for people who have myelofibrosis – a condition affecting the bone marrow – and have already been treated with a different medicine called ruxolitinib. The main goal is to compare a new drug, fedratinib, against other standard treatments to see which one works best. Researchers want to find out if fedratinib can shrink an enlarged spleen, which is a common problem in myelofibrosis, and help control other symptoms. This is a "Phase 3" study, meaning it's a large-scale final test to confirm if the new medicine is safe and effective before it can be widely used by patients.
De un vistazo
¿De qué trata este estudio?
This study is looking for better ways to treat a blood condition called myelofibrosis. Myelofibrosis causes scarring in your bone marrow, where blood cells are made. This can lead to problems like an enlarged spleen and feeling very tired. There are different types of myelofibrosis, and this study includes people with primary myelofibrosis, or those who developed it after having polycythemia vera or essential thrombocythemia.
Researchers want to see how a new medicine, called fedratinib, compares to other treatments that doctors often use. This study is for people who have already tried a different medicine called ruxolitinib for their myelofibrosis. We hope that fedratinib might be a more effective option for these patients.
The main thing the study will measure is whether fedratinib can shrink the size of an enlarged spleen. An enlarged spleen is a common symptom of myelofibrosis that can cause discomfort. The study will also look at whether the new medicine helps with other symptoms of myelofibrosis, such as tiredness or itching. By comparing fedratinib to existing treatments, we can learn if it's a safe and effective new choice for patients.
Puntos clave
- This study evaluates a new drug, fedratinib, for myelofibrosis.
- It's for patients who have previously taken ruxolitinib.
- The main goal is to see if fedratinib shrinks an enlarged spleen.
- Other common treatments will be compared against fedratinib.
- Participation involves regular clinic visits and health checks.
¿Quién puede ser elegible?
This study is for adults aged 18 and older. Both men and women can take part. You must have one of the types of myelofibrosis included in the study: primary myelofibrosis, or myelofibrosis that developed after you had polycythemia vera or essential thrombocythemia.
A key part of joining this study is that you must have already been treated with a medicine called ruxolitinib for your myelofibrosis. The study is specifically looking at how fedratinib works for people whose condition hasn't responded enough to ruxolitinib or if they couldn't continue taking it for other reasons.
There might be other specific health requirements or conditions that would mean you can or cannot join. These will be discussed in detail by the study team to make sure the study is right and safe 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.
- ¿Tienes 18 años o más?
- Do you have primary myelofibrosis, or myelofibrosis after polycythemia vera or essential thrombocythemia?
- Have you already been treated with ruxolitinib for your myelofibrosis?
- Are you prepared to attend regular clinic appointments for checks?
¿En qué consiste la participación?
If you decide to take part in this study, you will be randomly assigned to receive either the new medicine, fedratinib, or one of the common existing treatments for myelofibrosis. Neither you nor your doctor will get to choose which treatment you receive; this is decided by chance, like flipping a coin, to make the comparison fair.
You will have several visits to the clinic for medical checks, blood tests, and to measure the size of your spleen. These visits will help doctors monitor your health and see how well the treatment is working. You'll take the study medication regularly as instructed.
The study will involve regular follow-up appointments over a period of time to keep an eye on your progress and any side effects. The total duration of your participation will depend on how you respond to the treatment and the study plan, which will be fully explained to you before you agree to join.
Riesgos y beneficios potenciales
Locations (10)
- —No verificadoBélgica
- —No verificadoItalia
- —No verificadoHungría
- —No verificadoFrancia
- —No verificadoChequia
- —No verificadoAlemania
- —No verificadoPolonia
- —No verificadoIreland
- —No verificadoAustria
- —No verificadoEspaña
Preguntas comunes
¿Qué es la mielofibrosis?
Myelofibrosis is a condition where scar tissue builds up in your bone marrow, affecting how your body makes healthy blood cells.
What is fedratinib?
Fedratinib is a medicine being tested to see if it can help treat myelofibrosis, especially for people who have already tried another drug called ruxolitinib.
Why do they want to measure my spleen?
An enlarged spleen is a common problem in myelofibrosis. Measuring it helps doctors see if the treatment is working to reduce its size.
What does a 'Phase 3' study mean?
Phase 3 means this is a large study to thoroughly check if a new medicine is safe and effective compared to existing treatments, before it can be approved for wider use.
¿Definitivamente recibiré el nuevo medicamento?
No, you will be randomly assigned to receive either fedratinib or one of the other standard treatments, like drawing lots. It's a fair way to compare the medicines.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
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