ميثريدات: روكسوليتينيب مقابل هيدروكسيكارباميد أو إنترفيرون كعلاج خط أول في كثرة الحمر الحقيقية عالية الخطورة
The MITHRIDATE study is looking into the best first treatment for people in the UK and internationally who have a type of blood disorder called high-risk Polycythaemia Vera (PV). This condition causes the body to make too many red blood cells. Researchers want to compare a newer medicine called ruxolitinib with two established treatments: hydroxycarbamide or interferon. Participants will be randomly assigned to receive either ruxolitinib or one of the standard treatments. The goal is to find out which option is most effective and safest for newly diagnosed high-risk PV patients. This is a Phase III study, meaning it's a key step in understanding if ruxolitinib could become a new standard treatment.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Polycythaemia Vera (PV) is a long-term blood condition where your bone marrow makes too many red blood cells. This can sometimes lead to serious complications like blood clots. When PV is considered 'high risk,' it means there are certain factors that might increase your chances of these complications.
This study, called MITHRIDATE, is designed to compare different first-line treatments for people with high-risk PV. A common first treatment in the UK is hydroxycarbamide, and sometimes interferon is also used. This trial adds a newer drug, ruxolitinib, into the mix to see how it performs against these established therapies. The aim is to understand if ruxolitinib could be a better or equally good option for managing high-risk PV from the start.
By comparing these treatments directly, researchers hope to gather important information that can help doctors make the best decisions about which medicine to offer people with high-risk PV in the future. This kind of research is crucial for improving care and outcomes for patients.
النقاط الرئيسية
- Compares a new drug (ruxolitinib) with existing treatments for high-risk PV.
- Aims to find the best first treatment for patients.
- Participation involves random assignment to one of the treatments.
- Close medical monitoring throughout the study.
- يمكنك الانسحاب في أي وقت دون التأثير على رعايتك.
من قد يكون مؤهلاً؟
You might be able to join this study if you are 18 years or older and have been diagnosed with Polycythaemia Vera within the last 15 years, as long as it meets specific World Health Organisation (WHO) criteria. You also need to have ‘high-risk’ PV, which means you have a high white blood cell count and at least one other factor like being over 60, having had a previous blood clot or bleeding episode, a very high platelet count, or needing medication for high blood pressure or diabetes.
It’s important that your red blood cell count isn't too low, and you must not have been treated with more than one other drug for PV before, or had treatment for more than 10 years, unless it was just aspirin or blood letting. You also shouldn't be resistant or unable to tolerate any previous PV medication. You'll need to be generally well enough to take part and give your informed consent.
You wouldn't be able to join if your PV diagnosis was more than 15 years ago, if you don't have the JAK-2 gene change often seen in PV, or if you have certain other serious health issues like active infections (such as HIV or Hepatitis), uncontrolled cancers, or severe mental health conditions. Pregnant or breastfeeding individuals, or those with certain allergies, also wouldn’t be able to participate. If you are sexually active, you and your partner must agree to use effective contraception during the study and for a period afterwards.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك 18 سنة أو أكثر؟
- Have you been diagnosed with Polycythaemia Vera within the last 15 years?
- Do you have 'high-risk' PV based on your doctor's assessment (e.g., over 60, high white blood cells, or past clots)?
- Have you had no more than one previous treatment for PV, and for less than 10 years (excluding aspirin or blood letting)?
- Are you able to provide your written consent to take part?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, you will first undergo a series of checks to confirm you meet all the requirements. Once enrolled, you will be randomly assigned to one of two treatment groups: you'll either receive ruxolitinib or one of the standard treatments (hydroxycarbamide or interferon). Neither you nor your doctor will get to choose which group you are in, as this is decided by chance to ensure the study is fair.
The specific details on the number of clinic visits, tests, and the total length of your participation will be explained in full by the study team. You'll regularly see the study doctors and nurses for blood tests and other assessments to monitor your health and how well the treatment is working. This also involves ensuring that any side effects are managed safely. You will continue to receive your assigned medication throughout the study period, and detailed instructions will be provided on how to take it. Regular follow-up appointments will continue even after you finish the main treatment phase.
المخاطر والفوائد المحتملة
المواقع (61)
- مستشفى أبردين الملكيالرمز البريدي المؤكدأبردين، المملكة المتحدة· التوظيف
- مستشفى رويال يونايتدالرمز البريدي المؤكدباث، المملكة المتحدة· التوظيف
- Belfast City Hospitalالرمز البريدي المؤكدبلفاست، المملكة المتحدة· التوظيف
- مستشفى برمنغهام هارتلاندزالرمز البريدي المؤكدبرمنغهام، المملكة المتحدة· التوظيف
- مستشفى بلاكبول فيكتورياالرمز البريدي المؤكدبلاكبول، المملكة المتحدة· التوظيف
- Glan Clwyd Hospitalالرمز البريدي المؤكدBodelwyddan, United Kingdom· التوظيف
- مستشفى رويال بورنموثالرمز البريدي المؤكدبورنموث، المملكة المتحدة· التوظيف
- Southmead Hospitalالرمز البريدي المؤكدبريستول، المملكة المتحدة· التوظيف
- مستشفى أدينبروكالرمز البريدي المؤكدكامبريدج، المملكة المتحدة· التوظيف
- مستشفى كينت وكانتر بريالرمز البريدي المؤكدكانتربري، المملكة المتحدة· التوظيف
- مستشفى جامعة ويلزالرمز البريدي المؤكدكارديف، المملكة المتحدة· التوظيف
- St Richard's Hospitalالرمز البريدي المؤكدChichester, United Kingdom· التوظيف
أسئلة شائعة
What is Polycythaemia Vera (PV)?
It's a rare blood condition where your body makes too many red blood cells, which can make your blood thicker and increase the risk of blood clots.
What does 'high-risk' PV mean?
It means you have PV along with certain factors, like being over 60 or having had a previous blood clot, that might increase your chance of complications.
What are the treatments being compared?
The study compares ruxolitinib (a newer drug) with standard treatments like hydroxycarbamide or interferon.
هل سأعرف أي علاج سأحصل عليه؟
نعم، هذه دراسة "مفتوحة التسمية"، مما يعني أن كلا منكم أنت وطبيبك ستعرفان العلاج الذي تتلقاه.
هل يمكنني التوقف عن المشاركة إذا أردت؟
Yes, you have the right to withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.
كيفية معرفة المزيد
Natalia Morelli
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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