Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants with Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)
This research study is for adults with a type of skin cancer called Mycosis Fungoides or Sezary Syndrome, specifically when it has returned or hasn't responded well to other treatments. The main goal is to check the safety of a drug called mogamulizumab, also known as Poteligeo, which is given as an infusion. Researchers want to see how patients react to the drug when it's given every four weeks after an initial period of treatment. This is a Phase 2 study, meaning it's an early step to understand the drug better, focusing on side effects and basic body responses, before looking at how well it treats the cancer in larger groups of people. Participants will have regular checks like blood tests, physical exams, and heart tests.
At a glance
What is this study about?
This study is about a type of cancer that starts in certain white blood cells (T-cells) and mainly affects the skin, called Mycosis Fungoides or Sezary Syndrome. For some people, these conditions can come back after treatment or become difficult to treat with standard methods. This study is testing a new medicine called mogamulizumab, also known by its brand name Poteligeo, for these situations.
The main purpose of this study is to understand how safe mogamulizumab is for patients. Researchers want to see what side effects might occur when the drug is given as an infusion every four weeks, after patients have received an initial course of treatment. They will be closely monitoring participants' health, including performing blood tests, physical examinations, checking vital signs (like blood pressure and heart rate), and doing ECGs (tests of heart activity).
Beyond safety, the study also looks at other important information. This includes how the drug moves through the body over time, if the body develops antibodies against the drug (which could affect how well it works), and if the drug helps to shrink the cancer or keep it from getting worse. They will also examine blood and tissue samples to see how the disease and certain cells change with treatment. This is a Phase 2 study, which means it's an important step in learning more about a new treatment before it can be widely used.
Key takeaways
- This study is for adults with tough-to-treat skin lymphomas (Mycosis Fungoides/Sezary Syndrome).
- It's testing a new drug called mogamulizumab (Poteligeo) given by drip.
- The main focus is to check how safe the drug is and what side effects it might have.
- Participants will have regular check-ups, blood tests, and heart tests.
- It's an early-stage study, so results might not show if the drug works for everyone.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Critically, you must have Mycosis Fungoides or Sezary Syndrome that has either come back after previous treatment or has not responded well to other treatments. The study is specifically designed for people with these difficult-to-treat forms of the condition.
There might be other specific health requirements or conditions that would prevent someone from joining, which the study doctors would discuss with you. These could include other health problems, previous treatments, or certain medications you might be taking.
- Are you 18 years old or older?
- Do you have Mycosis Fungoides or Sezary Syndrome?
- Has your condition come back or not responded well to previous treatments?
- Are you able to attend regular hospital visits for infusions and tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will receive the study medication, mogamulizumab, which is given through a drip (infusion). You'll have an initial period of treatment, followed by ongoing infusions every four weeks. Throughout the study, you'll have regular hospital visits for various tests and checks.
These checks will include blood tests to look at your overall health, how the drug is working in your body, and to check for any potential side effects. You'll also have physical examinations, where the doctors will check your general health and how your skin condition is responding. Vital signs, like your blood pressure and heart rate, will be monitored, and you'll have ECGs to check your heart's electrical activity. Doctors will also measure how your cancer is responding.
The total duration of your participation will depend on how you respond to the treatment and the study requirements, but you should expect regular follow-up for a significant period. You'll be given a detailed schedule of visits and procedures if you're considered for the study.
Potential risks and benefits
Locations (2)
- —Spain
- —France
Common questions
What is Mycosis Fungoides/Sezary Syndrome?
These are slow-growing cancers that affect a type of white blood cell called T-cells, mainly showing up on the skin.
What is mogamulizumab (Poteligeo)?
It's a study drug given through a drip (infusion) that aims to treat certain types of T-cell skin lymphoma.
What does 'relapsed/refractory' mean?
It means the condition has come back after treatment or hasn't responded to previous treatments.
What is a Phase 2 study?
It's an early step in testing a new drug, mostly to check its safety and see if it has any effect, in a smaller group of people.
Will this drug cure my condition?
We cannot say, as this is a research study. The main goal is to understand the drug's safety and how it affects the condition, not to offer a cure for everyone.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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