AuthorisedTherapeutic exploratory (Phase II)Interventional

Combination Therapy with Interferon-Alpha2a and Ruxolitinib in Newly Diagnosed Patients with Polycythemia Vera. A Danish Safety and Efficacy Study.

This research is a 'Phase II' study, which means it's an early look into combining two existing medicines for people who have just been diagnosed with Polycythemia Vera. The two medicines are called Peginterferon alfa-2a and Ruxolitinib, also known as Jakavi. Doctors are trying to find out how safe this combination of treatments is. They will also be observing how well the medicines help control the condition, such as whether they can reduce certain blood counts to healthy levels and if they lower the chance of problems like blood clots or bleeding. The study aims to gather important information to help future patients with Polycythemia Vera.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Sjaelland

Enrolment target

Start

04 Nov 2024

Polycythemia

What is this study about?

This study is looking at a condition called Polycythemia Vera. This is a rare blood disorder where your body makes too many red blood cells, and sometimes too many white blood cells and platelets too. Having too many of these blood cells can make your blood thicker, increasing the risk of serious problems like blood clots or bleeding. This study wants to see if combining two specific medicines might be a good new way to help people who have just been diagnosed with this condition.

The two medicines being tested are Peginterferon alfa-2a and Ruxolitinib. Peginterferon alfa-2a is a type of medicine that helps control how your bone marrow makes blood cells. Ruxolitinib, also known by its brand name Jakavi, works by targeting specific signals in your body that can lead to too many blood cells being made.

The main goal of this study is to carefully watch for any side effects or problems that might happen when these two medicines are used together. This helps doctors understand how safe the combination is. They will also be checking to see if these medicines work well together to manage Polycythemia Vera, for example, by bringing blood cell counts back to normal ranges and reducing the risk of complications over time.

Key takeaways

This study is for newly diagnosed adults with Polycythemia Vera.
It tests a combination of two established medicines, Peginterferon alfa-2a and Ruxolitinib (Jakavi).
The main focus is on how safe the combination treatment is.
Researchers also want to see if the treatment helps control blood counts and prevents complications.
Participants will have regular check-ups and blood tests over up to two years.
Your decision to join or leave the study will not affect your standard medical care.

Who may be eligible?

To be able to join this study, there are a few important things that need to be true about you.

First, you must be an adult aged 18 years or older. There is no upper age limit, meaning people of all adult ages can be considered. Also, both men and women can take part in this research.

Because this study is looking at new ways to treat people who have just found out they have Polycythemia Vera, you would typically need to have received your diagnosis recently. The doctors running the study will have other specific medical criteria to make sure the study treatment is right for you, and that it's safe for you to participate.

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?
Have you recently been diagnosed with Polycythemia Vera (not a long-term condition)?
Are you able to attend regular hospital or clinic appointments?
Do you feel comfortable taking study medication as instructed?
Do you understand that there might be specific medical criteria your doctor will check?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have some checks to make sure the study is right for you. If you qualify, you would then start taking the two study medications, Peginterferon alfa-2a and Ruxolitinib, as prescribed by the study doctors. You would have regular appointments at the hospital or clinic. These visits would involve check-ups, blood tests, and discussions with the study team to monitor your health and see how the treatment is working and if you are having any side effects. The exact number of visits and tests would be explained to you, but they would happen over a period of up to two years, with follow-up appointments at specific times like 3, 6, 9, 12, 18, and 24 months. You would continue to receive careful medical care throughout your time in the study.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a combination of treatments that could help manage your Polycythemia Vera, and you would be closely monitored by medical experts. However, like all medicines, the treatments have potential risks and may cause side effects, some of which could be serious. The study team will explain these potential risks to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is Polycythemia Vera?

It's a blood disorder where your body makes too many blood cells, which can make your blood thicker and increase the risk of clots.

What medicines are being tested?

The study is looking at a combination of Peginterferon alfa-2a and Ruxolitinib (Jakavi).

Why combine these two medicines?

Researchers want to see if using these medicines together is safer and works better for controlling Polycythemia Vera.

How long will the study last?

Participants will be followed for up to 24 months (two years) to see how the treatment works over time.

Can I stop participating if I want to?

Yes, you can leave the study at any point without it affecting your normal medical care.