In short
Currently, there is 1 ongoing clinical trial for patients with Stage I Cutaneous T-cell Lymphoma. This trial is testing a combination treatment approach using mogamulizumab, a targeted antibody therapy, together with Total Skin Electron Beam therapy. The study is being conducted across multiple European countries and is open to patients with early to intermediate stages of the disease who have already tried at least one previous treatment.
Clinical trial locations
- Denmark
- France
- Germany
- Greece
- Italy
- Spain
Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
This clinical trial is testing a combination treatment for patients with Mycosis Fungoides, a subtype of cutaneous T-cell lymphoma. The study brings together two treatment approaches: mogamulizumab, a medication that helps the immune system target cancer cells, and Total Skin Electron Beam therapy, a specialized form of radiation that treats the entire skin surface.
Who can participate:
- Adults aged 18 years or older, both men and women
- Patients diagnosed with Mycosis Fungoides at stages IB, IIA, or IIB
- Those who have already tried at least one previous treatment that affects the whole body (except for PUVA therapy, which does not count)
- Patients whose blood and organs are functioning adequately
- Those willing to provide informed consent after understanding what the study involves
Who cannot participate:
- Patients with other types of cancer besides the specific skin-related cancer being studied
- Those with serious, uncontrolled infections
- Patients with a history of severe allergic reactions to similar treatments
- Pregnant or breastfeeding women
- Those who participated in another clinical trial within the last 30 days
- Patients with unstable heart conditions
- Those with severe liver or kidney problems
- Patients with a history of drug or alcohol abuse that could affect the study
- Anyone unable to follow the study procedures
What the trial aims to achieve:
The main goal of this study is to evaluate how well the combination of mogamulizumab and Total Skin Electron Beam therapy works in controlling the cancer. Researchers will measure progression-free survival at 48 weeks, meaning they want to see how many patients remain free of cancer progression during this time. The study will also monitor overall safety, response rates, overall survival, and the impact on patients' quality of life.
Investigational treatments:
Mogamulizumab is a monoclonal antibody that targets a specific protein called CCR4 found on certain cancer cells. By attaching to this protein, the medication helps the immune system recognize and destroy these cancerous cells. It is given through an intravenous infusion.
Total Skin Electron Beam Therapy (TSEB) is a form of radiation treatment that uses a beam of electrons to treat the entire skin surface. This approach effectively targets cancer cells in the skin while minimizing damage to deeper tissues.
Throughout the trial, patients will receive the combination treatment according to a specific schedule. They will be closely monitored through regular check-ups to assess how they respond to the treatment and to watch for any side effects. Follow-up visits will continue to evaluate both the safety and effectiveness of this treatment combination.
Summary
There is currently one active clinical trial available for patients with Stage I Cutaneous T-cell Lymphoma. This trial represents an important research effort combining immunotherapy with radiation therapy. The study is notable for its wide European presence, being conducted across six countries: Denmark, France, Germany, Greece, Italy, and Spain. This broad geographic distribution may provide better access for patients across Europe.
The trial focuses specifically on patients with Mycosis Fungoides at stages IB through IIB who have already tried other treatments. The combination approach being tested—mogamulizumab with Total Skin Electron Beam therapy—represents an effort to improve outcomes by using two different methods to target the cancer simultaneously. Mogamulizumab works by helping the immune system attack cancer cells, while the radiation therapy directly treats the affected skin.
For patients considering participation, it is important to note that this trial requires previous treatment experience and adequate organ function. The study will run for 48 weeks with regular monitoring to assess both how well the treatment works and its safety profile.
