All studies
RecruitingPHASE2INTERVENTIONAL

Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

This research study is investigating a new treatment approach for people with early stages (IB-IIB) of Cutaneous T-cell Lymphoma (CTCL), a type of skin cancer. The study combines a special medicine, mogamulizumab, with a form of radiation therapy called Total Skin Electron Beam (TSEB). The idea is to give mogamulizumab first to help control the disease throughout the body, then follow with TSEB to treat the skin areas, and finally use mogamulizumab again as a continued treatment. Doctors hope this sequence will be more effective than current options, lead to fewer side effects, and allow for long-term treatment, ultimately improving how well patients respond and their quality of life. This trial is for patients whose previous treatments haven't worked or whose cancer has returned.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Enrolment target
43
Start
07 Mar 2023
Estimated completion
01 Jan 2027

What is this study about?

Cutaneous T-cell Lymphoma (CTCL) is a type of cancer that starts in white blood cells and primarily affects the skin. It can be a long-lasting condition, and people often need many different treatments over time. The main goals of treatment are to clear up skin problems, stop the cancer from coming back or getting worse, and help people live as well as possible.

For early stages of CTCL, treatments that focus on the skin can often lead to long periods where the cancer is under control. However, for more advanced stages or if the cancer doesn't respond well to initial treatments, it can be much harder to treat. At the moment, there isn't one standard treatment that works for everyone, especially for advanced CTCL, and doctors are constantly looking for better options. That's why studies like this are so important – they help us find new and more effective ways to fight the disease.

This particular study is trying a new and different schedule for treating CTCL. It involves using a medicine called mogamulizumab before a type of radiation treatment called Total Skin Electron Beam (TSEB). Mogamulizumab is designed to work throughout the body, while TSEB is a special radiation therapy that treats the whole skin surface. After the TSEB, patients will continue to receive mogamulizumab. The hope is that this specific order of treatments will help control the disease better, have fewer side effects compared to other combinations, and allow people to stay on treatment for a longer time, potentially leading to better and more lasting results.

Key takeaways

  • Targets early stages of Cutaneous T-cell Lymphoma (stages 1B-2B).
  • Combines a drug (mogamulizumab) with skin radiation (TSEB) in a new sequence.
  • Hopes to find a more effective treatment with fewer side effects.
  • For patients whose previous treatments haven't worked or whose cancer has returned.
  • Requires healthy organ function and agreement to use contraception if applicable.

Who may be eligible?

This study is looking for people who have been diagnosed with Mycosis fungoides, which is a common type of CTCL, specifically in stages 1B, 2A, or 2B. To join, you must be at least 18 years old and have already tried at least one other treatment for your cancer that didn't work or where your cancer came back.

There are also some important health checks you'll need to pass. For example, your blood tests for things like your white blood cells, platelets, and liver and kidney function need to be within a healthy range. Any side effects you had from previous cancer treatments must have mostly cleared up, meaning they are mild or gone. Your heart also needs to be working well.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 6 months after your last dose. Men who are able to have children will also need to use effective birth control with their partners during the study.

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.

  1. Are you 18 years or older?
  2. Do you have Mycosis fungoides, stage 1B, 2A, or 2B?
  3. Have you already tried at least one other systemic cancer treatment that didn't work or where your cancer came back?
  4. Are any side effects from your previous treatments mostly gone or very mild?
  5. Are you able to use effective birth control during the study if applicable?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the study drug, mogamulizumab, and a special type of radiation therapy called Total Skin Electron Beam (TSEB). The study involves a specific sequence: you'll first receive mogamulizumab injections, then undergo TSEB radiation, and finally, continue with mogamulizumab injections as a maintenance treatment. You will have regular appointments for check-ups, blood tests, and to monitor your health and response to treatment. The total duration of the study treatment and follow-up will be discussed with you by the research team. You'll need to attend clinic visits for your treatments and to have various assessments to see how you're doing. The research team will explain the full schedule, including how often you'll need to visit and for how long.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could be more effective for your condition. However, there's no guarantee the treatment will work for you, and like all medicines and radiation, mogamulizumab and TSEB can have side effects, which the research team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Hospitals Copenhagen - Rigshospitalet
    Verified postcode
    Copenhagen, Denmark· Recruiting
  • CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre
    Verified postcode
    Bordeaux, France· Recruiting
  • Assistance Publique Hopitaux Paris- APHP Nord - Univ De Paris Cite - Hop. Saint Louis
    Verified postcode
    Paris, France· Recruiting
  • UniversitaetsMedizin Mannheim
    Verified postcode
    Mannheim, Germany· Recruiting
  • Muehlenkreiskliniken Johannes Wesling Klinikum Minden
    Verified postcode
    Minden, Germany· Recruiting
  • Athens University - Attikon University General Hospital
    Verified postcode
    Athens, Greece· Recruiting
  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
    Verified postcode
    Brescia, Italy· Recruiting
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro
    Verified postcode
    Torino, Italy· Recruiting
  • Hospital De La Santa Creu I Sant Pau
    Verified postcode
    Barcelona, Spain· Recruiting
  • Hospital Universitario 12 De Octubre
    Verified postcode
    Madrid, Spain· Recruiting
  • Hospital Universitario Puerta De Hierro
    Verified postcode
    Madrid, Spain· Recruiting
  • University Hospitals Birmingham NHS Foundation Trust (UHB) -Queen Elizabeth Medical Centre
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What is Cutaneous T-cell Lymphoma (CTCL)?

CTCL is a type of cancer that starts in a specific kind of white blood cell and mainly affects the skin, causing rashes, plaques, or tumours.

Who is mogamulizumab for?

Mogamulizumab is an approved treatment for certain types of CTCL, and in this study, it's being tested in a new treatment plan for specific stages of the disease.

What is Total Skin Electron Beam (TSEB) therapy?

TSEB is a type of radiation therapy that treats the entire surface of the skin with electron beams to help control skin lesions caused by CTCL.

What stage of CTCL is this study for?

This study is specifically for people with Mycosis fungoides, an early form of CTCL, in stages 1B, 2A, or 2B.

Will I get both mogamulizumab and TSEB?

Yes, if you join this study, you will receive both mogamulizumab and TSEB therapy in a specific order outlined by the research plan.

How to find out more

EORTC EORTC HQ

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.