AuthorisedTherapeutic exploratory (Phase II)Interventional

RuxoTam; A phase II study to evaluate safety and efficacy of tamoxifen in combination with Ruxolitinib in patients with myelofibrosis

This research study, called RuxoTam, is exploring a new treatment approach for myelofibrosis, a rare condition where your bone marrow doesn't make enough healthy blood cells. The study is combining two existing medicines: tamoxifen and ruxolitinib. Tamoxifen is typically used for other conditions, and ruxolitinib is already approved for myelofibrosis. The main goal is to find out if this combination is safe for patients and if it can improve their symptoms or slow down the disease more effectively than ruxolitinib alone. This is a Phase II study, meaning it's still in the earlier stages of testing new treatments, focusing on how well it works and any side effects. It’s open to adult patients with myelofibrosis of all genders.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

11 Nov 2025

Myelofibrosis

What is this study about?

This study, called RuxoTam, is trying to find better ways to treat a serious blood condition called myelofibrosis. In myelofibrosis, the bone marrow, which is inside your bones and makes blood cells, becomes scarred and can't produce enough healthy red blood cells, white blood cells, and platelets. This can cause symptoms like extreme tiredness, weight loss, an enlarged spleen, and a higher risk of infections or bleeding. Current treatments aim to manage these symptoms and slow the disease's progression.

Researchers are investigating whether combining two medicines, tamoxifen and ruxolitinib, could be more effective. Ruxolitinib is a medicine already used to treat myelofibrosis. Tamoxifen is a medicine that has been used for many years to treat other conditions, such as breast cancer, and the researchers believe it might also have a role in treating myelofibrosis when used with ruxolitinib. This study is in an early stage (Phase II), meaning it’s designed to check if the new combination is safe and if it shows promise in improving the condition for patients.

The main aim is to see if this combined treatment can reduce symptoms, improve quality of life, and potentially slow down the disease more than ruxolitinib alone. By taking part, you would be helping doctors learn more about myelofibrosis and contributing to the development of new treatments that could help many people in the future. It's an important step in understanding how different medicines might work together to fight this challenging illness.

Key takeaways

This study combines two existing drugs, tamoxifen and ruxolitinib, for myelofibrosis.
It's a Phase II study, checking for safety and how well the combination works.
The goal is to find a more effective treatment for myelofibrosis symptoms and progression.
Open to adults aged 18 and over with myelofibrosis.
Participation involves taking daily medication and attending regular hospital visits for monitoring.
You can stop participating at any time without affecting your ongoing medical care.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with myelofibrosis. Both men and women are welcome to take part in this research.

There will be other, more detailed requirements that the study team will need to check to make sure the treatment is safe and suitable for you. For example, they will look at your overall health, any other medical conditions you have, and the specific characteristics of your myelofibrosis. These checks are put in place to protect your safety and to make sure the study results are clear.

If you are interested, the study team will go through all the specific criteria with you and your doctor to see if you are a good fit for this particular study. They will also discuss any treatments you might currently be receiving, as these could affect your eligibility.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with myelofibrosis?
Are you able to take medication by mouth?
Are you willing and able to attend regular hospital appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would primarily receive two medications: tamoxifen and ruxolitinib. Both will be given as tablets that you take by mouth. You would have regular appointments at the hospital, likely at the beginning of the study, and then periodically throughout, to check your health, monitor for any side effects, and see how the treatment is working. These appointments will involve blood tests, physical examinations, and possibly other scans or tests depending on what the doctors need to assess.

The study team will carefully track your progress, symptoms, and any changes in your condition. You will be asked to report how you are feeling and any side effects you might experience. The total duration of your participation in the study, including the treatment period and follow-up, will be explained in detail by the study team. This typically involves several months to over a year of close monitoring.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new combination treatment for your myelofibrosis that could be more effective than existing options. However, there's no guarantee of personal benefit, and the treatment might not work for everyone. As with all medications, tamoxifen and ruxolitinib can cause side effects, which could range from mild to serious. The study team will closely monitor you for any side effects and discuss these risks with you in detail before you decide to join. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is myelofibrosis?

Myelofibrosis is a rare blood disorder where your bone marrow, which makes blood cells, becomes scarred. This scarring makes it hard for your body to produce enough healthy blood cells, which can lead to tiredness, weakness, and other health problems.

What is a Phase II study?

A Phase II study is an early stage of testing a new treatment. It's designed to see if the treatment works well and is safe for patients, after initial safety checks have been done in Phase I.

Are tamoxifen and ruxolitinib new drugs?

No, both tamoxifen and ruxolitinib are established drugs. Ruxolitinib is already used for myelofibrosis, and tamoxifen is used for other conditions. The new part is using them together for myelofibrosis.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatment or the extra study-related visits and tests if you participate. Some studies may cover travel costs, but you should ask the study team about this.

What happens if I want to leave the study?

You are completely free to leave the study at any time, for any reason, without needing to explain why. Your decision will not affect your future medical care or relationship with your doctors.