Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
This research study is looking at two medicines, givinostat and hydroxyurea, for a blood condition called polycythemia vera (PV). PV causes your body to make too many red blood cells. The study wants to find out if givinostat works better and is safer than hydroxyurea, which is a common treatment. It’s for patients who have a higher chance of developing blood clots because of their PV and have a particular gene change (JAK2V617F). The study is in its third phase, meaning the treatments have already been tested in smaller groups. We want to understand if givinostat can offer a better way to manage PV and its symptoms.
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¿De qué trata este estudio?
Polycythemia vera (PV) is a type of blood disorder where your body makes too many blood cells, especially red blood cells. This can make your blood thicker, increasing the risk of serious problems like blood clots, which can lead to strokes or heart attacks. In some cases, PV can also turn into other more serious blood conditions over time. Many patients with PV have a specific change in a gene called JAK2V617F, which is a key driver of the disease.
Currently, one common treatment for PV is a medicine called hydroxyurea. However, for many patients, hydroxyurea doesn't fully control their symptoms or reduce their long-term risks effectively. Doctors are always looking for better ways to treat PV, especially for patients who are at a higher risk of complications, such as those over 60 years old or those who have had a blood clot before.
This study is comparing hydroxyurea with a new medicine called givinostat. Givinostat belongs to a group of drugs that have shown promise in slowing down the growth of unhealthy cells. Early studies have suggested that givinostat might be helpful for patients with PV caused by the JAK2V617F gene change and seems to have an acceptable safety profile. The main goal of this study is to see if givinostat is more effective than hydroxyurea at managing PV and keeping you healthy.
Puntos clave
- This study compares givinostat with hydroxyurea for high-risk polycythemia vera.
- It's for people with a specific JAK2 gene change.
- The aim is to find out if givinostat is safer and more effective.
- Participation involves taking one of the two medicines and regular check-ups.
- You'll be closely monitored for both benefits and side effects.
- Puedes dejar de participar en cualquier momento.
¿Quién puede ser elegible?
To join the main part of this study, you must be an adult aged 18 or over and have been diagnosed with polycythemia vera (PV) caused by the JAK2V617F gene change. You'd be considered at a higher risk of blood clots, which means you're either 60 years old or older, or you've had a blood clot in the past three years. You also need to be currently needing treatment for your PV, for example, if your red blood cell count, white blood cell count, or platelet count is too high.
There are also some reasons why you might *not* be able to join. For example, if you've had certain heart problems recently, have other serious health conditions like issues with your liver or kidneys, or have very high levels of fats in your blood. If you've previously had problems taking hydroxyurea (meaning it didn't work or caused severe side effects), you also wouldn't be able to join.
If you successfully complete the main part of the study, you might then be able to continue into an extended treatment phase. This allows patients who benefited from givinostat, or those who didn't fully respond to hydroxyurea, to keep taking givinostat long-term to gather more information.
¿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?
- Have you been diagnosed with polycythemia vera (PV)?
- Does your PV have the JAK2V617F gene change?
- Are you considered at 'high risk' for blood clots (e.g., over 60 or had a clot before)?
- Are you currently needing treatment for your PV (e.g., high blood counts)?
- Have you *not* had severe heart problems or other serious health issues recently?
¿En qué consiste la participación?
If you join this study, you will be given either givinostat or hydroxyurea. Neither you nor your doctor will get to choose which medicine you receive, as this is decided randomly, like flipping a coin. You will be closely monitored throughout the study with regular hospital visits, blood tests, and check-ups to see how the treatment is working and if you experience any side effects. The main part of the treatment will last for 48 weeks (about 11 months).
After this main period, if you meet certain criteria, you might be able to continue receiving givinostat in an 'extended treatment phase'. This extra phase would allow doctors to collect more information on the long-term effects and safety of givinostat. The total duration of your participation, including any extended phase, would be discussed with you, but typically clinical trials involve regular follow-ups for a significant period.
Riesgos y beneficios potenciales
Locations (90)
- University of Alabama at BirminghamCódigo postal verificadoBirmingham, United States· Aún no reclutando
- Emad Ibrahim, MD, IncCódigo postal verificadoRedlands, United States· Reclutamiento
- US Oncology IncCódigo postal verificadoEnglewood, United States· Reclutamiento
- American Oncology Partners of Maryland, PACódigo postal verificadoBethesda, Estados Unidos· Reclutamiento
- Escuela de Medicina Icahn en Mount SinaiCódigo postal verificadoNueva York, Estados Unidos· Reclutamiento
- University of North Carolina at Chapel HillCódigo postal verificadoChapel Hill, United States· Reclutamiento
- The Cleveland Clinic FoundationCódigo postal verificadoCleveland, United States· Reclutamiento
- Oncology Associates of Oregon, P.C.Código postal verificadoEugene, United States· Reclutamiento
- MD Anderson Cancer CenterCódigo postal verificadoHouston, Estados Unidos· Reclutamiento
- Texas Oncology (Webster) - USORCódigo postal verificadoHouston, Estados Unidos· Reclutamiento
- Texas Oncology-Denison Cancer CenterCódigo postal verificadoSherman, Estados Unidos· Reclutamiento
- University of Utah - Huntsman Cancer Institute - PPDSCódigo postal verificadoSalt Lake City, Estados Unidos· Reclutamiento
Preguntas comunes
What is polycythemia vera (PV)?
It's a rare blood disorder where your body makes too many red blood cells, which can make your blood thicker and increase your risk of blood clots.
What does 'high-risk' PV mean?
It means you have a higher chance of developing serious complications like blood clots. This usually applies if you are over 60 or have had a blood clot before.
What is a 'JAK2V617F mutation'?
This is a specific change in a gene that is often found in people with PV and helps drive the disease.
Is givinostat a new medicine?
Yes, it's an investigational medicine being tested in this study to see if it's a better treatment option for PV than existing ones.
Can I choose which treatment I get?
No, in this type of study, the treatment you receive (either givinostat or hydroxyurea) is chosen randomly by a computer, not by you or your doctor.
Cómo obtener más información
Maurizio Caserini
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.