In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for patients with refractory cutaneous T-cell lymphoma. This trial is testing a combination of mogamulizumab, an immunotherapy medication, together with Total Skin Electron Beam therapy across multiple European countries.
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 trial is investigating a combination treatment approach for patients with cutaneous T-cell lymphoma, specifically the Mycosis Fungoides and Sézary Syndrome subtypes. The treatment combines an immunotherapy medication called mogamulizumab with a specialized radiation technique known as Total Skin Electron Beam therapy (TSEB).
Main focus: The study aims to evaluate how well this combination treatment works in patients with stage IB to IIB disease. Researchers are particularly interested in measuring how long patients can live without their cancer getting worse, which is called progression-free survival. The trial will track participants over 48 weeks to assess this primary outcome, while also monitoring overall safety, response rates, quality of life, and how long any positive responses last.
Investigational drugs: Mogamulizumab is a monoclonal antibody that works by targeting a specific protein called CCR4 found on certain cancer cells. By attaching to this protein, it helps the immune system recognize and destroy these cancerous T-cells. The medication is given through an intravenous infusion and is combined with TSEB, which uses electron beam radiation directed at the entire skin surface to kill cancer cells while minimizing damage to deeper tissues.
Who can participate: The trial is open to adults aged 18 years or older who have been diagnosed with Mycosis Fungoides at stages IB, IIA, or IIB. Participants must have tried at least one previous treatment that affects the whole body, though Psoralen plus ultraviolet light therapy (PUVA) does not count toward this requirement. Additionally, participants must have adequate blood counts and organ function, and they must provide signed informed consent after understanding what participation involves.
Who cannot participate: The trial excludes patients who have other types of cancer beyond the specific skin-related cancer being studied, those with serious uncontrolled infections, or anyone with a history of severe allergic reactions to similar treatments. Pregnant or breastfeeding women cannot participate, nor can individuals who have joined another clinical trial within the last 30 days. Other exclusion criteria include unstable heart conditions, severe liver or kidney problems, a history of substance abuse that could affect the study, or an inability to follow the study procedures.
Summary
This single ongoing trial represents an important investigation into combination therapy for patients with refractory cutaneous T-cell lymphoma. The study is being conducted across six European countries: Italy, Germany, Greece, France, Spain, and Denmark, demonstrating a coordinated international effort to advance treatment options for this rare disease.
The trial focuses on combining immunotherapy with radiation therapy, specifically using mogamulizumab alongside Total Skin Electron Beam therapy. This approach represents an innovative strategy that aims to harness both the immune system's power to target cancer cells and the direct cancer-killing effects of specialized radiation treatment.
Patients with stage IB to IIB Mycosis Fungoides who have already tried at least one systemic treatment may find this trial particularly relevant. The study's design includes comprehensive monitoring of both effectiveness and safety outcomes, as well as quality of life assessments, which are important considerations for patients managing this chronic condition.
