Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Investigator Initiated, descriptive, proof-of-concept, open-label pilot study targeting the tumor microenvironment and skin barrier deficiency through JAK1/3 inhibition

This study is looking into a new use for a medicine called Xeljanz (which comes as 10mg tablets) for adults who have a type of skin lymphoma called Mycosis Fungoides. It's a pilot study, meaning it's an early test to see if the medicine works and is safe in this group of patients. Researchers will carefully watch to see if people taking part show signs of their condition getting better, staying the same, or getting worse, to figure out if Xeljanz could be a helpful treatment option in the future. Anyone aged 18 or over can potentially take part.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Aarhus University Hospital

Enrolment target

Start

08 Jul 2022

Mycosis Fungoides

What is this study about?

This research study is about a medication called Xeljanz (pronounced Zell-janz) and how it might help people living with Mycosis Fungoides. Mycosis Fungoides is a rare type of cancer that starts in white blood cells and mostly affects the skin, causing rashes, plaques, or tumours.

Doctors are currently exploring whether Xeljanz, which is already used to treat other conditions, could be an effective treatment for Mycosis Fungoides. We know that Mycosis Fungoides involves problems with the body's immune system and also with the skin's protective barrier. Xeljanz works by calming down parts of the immune system that might be overactive, and this study aims to see if that approach can help improve the condition.

This is a 'Phase II' study, which means it's an important early step in testing a new treatment. We are looking to see if the medicine works well enough to consider more extensive studies down the line. We will be carefully observing how patients respond to the treatment – whether their condition improves, stays stable, or changes, to understand its potential benefits.

Key takeaways

Testing Xeljanz medication for Mycosis Fungoides.
Aimed at adults aged 18 and over.
Involves taking 10mg tablets and regular check-ups.
It's an early-stage study to see if the treatment works.
May help your condition and contribute to research.
Potential side effects, but you can leave the study at any time.

Who may be eligible?

To join this study, you must be 18 years old or older. There is no upper age limit, so people of all adult ages can take part.

This study is open to both men and women.

More detailed health checks will be done by the study team to make sure it's safe and right for you to join. These checks will make sure that the study medicine is specifically suitable for your individual health situation.

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?
Do you have Mycosis Fungoides?
Are you willing to take study medication (Xeljanz tablets)?
Are you able to attend regular appointments for health checks?
Are you comfortable with blood tests and physical examinations?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given Xeljanz 10mg tablets to take. Over the course of the study, you'll have regular appointments where the doctors will check your general health, examine your skin and any affected areas, and ask about any changes you notice. You'll also have blood tests and other assessments to monitor how you're responding to the treatment and to check for any side effects. The study will last for a set period, and you'll have follow-up visits after you finish taking the medication to ensure everything is well.

Potential risks and benefits

Taking part in this study could potentially help improve your Mycosis Fungoides, though there's no guarantee the treatment will work for everyone. You'll also be contributing to important medical research that could help others in the future. However, like all medicines, Xeljanz can have side effects, and some are serious. The study team will explain all known risks to you in detail. You are free 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 Mycosis Fungoides?

It's a rare type of cancer affecting white blood cells that primarily shows up on the skin, causing various rashes or patches.

What is Xeljanz?

It's a medicine that works by calming down parts of the immune system and is being tested for Mycosis Fungoides in this study.

How will I take the medicine?

You will take Xeljanz as 10mg tablets, as instructed by the study doctor.

How long will the study last?

The study will last for a specific period, including treatment and follow-up, which the study team will explain.

Will I still see my regular doctor?

Yes, you should continue to see your regular doctor for your usual care, working alongside the study team.