In short
There is currently 1 ongoing clinical trial for patients with Stage II Cutaneous T-cell Lymphoma. This trial is investigating a combination treatment approach using mogamulizumab, a targeted immunotherapy, together with Total Skin Electron Beam therapy (TSEB) 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 testing a combination treatment approach for patients with Cutaneous T-cell Lymphoma, specifically those with Mycosis Fungoides at stages IB to IIB. The study combines two treatments: mogamulizumab, a medication given through an intravenous infusion, and Total Skin Electron Beam therapy, a specialized form of radiation therapy that targets the entire skin surface.
Main inclusion criteria:
- Adults aged 18 years or older
- Diagnosis of Mycosis Fungoides at stage IB, IIA, or IIB
- Previous treatment with at least one systemic therapy (treatments that affect the whole body), excluding Psoralen plus ultraviolet light therapy
- Adequate blood and organ function
- Ability to provide informed consent
Main exclusion criteria:
- Other types of cancer besides the specific condition being studied
- Uncontrolled serious infections
- History of severe allergic reactions to similar treatments
- Pregnancy or breastfeeding
- Participation in another clinical trial within the past 30 days
- Unstable heart conditions
- Severe liver or kidney problems
- History of substance abuse that could interfere with the study
Focus and goals: The primary goal of this trial is to evaluate how long patients can live without their cancer getting worse when treated with this combination therapy. Researchers will monitor patients over 48 weeks to measure progression-free survival. The study will also assess the overall safety of the treatment combination, how well patients respond to the therapy, overall survival rates, and the impact on patients' quality of life.
Investigational treatments:
- Mogamulizumab (also known as KW-0761 and AMG 761): This is a monoclonal antibody that targets a specific protein called CCR4 found on the surface of certain cancer cells. By attaching to this protein, mogamulizumab helps the immune system recognize and destroy these cancerous T-cells. It is administered as an intravenous infusion.
- Total Skin Electron Beam Therapy (TSEB): This is a form of radiation therapy that directs a beam of electrons at the entire skin surface to kill cancer cells while minimizing damage to deeper tissues. It is often used for skin conditions like this type of lymphoma.
Throughout the trial, participants will receive regular monitoring to assess how they respond to treatment and to watch for any side effects. The study includes initial assessments, a treatment phase, regular monitoring and follow-up visits, and evaluation of outcomes to determine the effectiveness and safety of this combined approach.
Summary
Currently, there is one active clinical trial available for patients with Stage II Cutaneous T-cell Lymphoma. This trial is being conducted across six European countries: Denmark, France, Germany, Greece, Italy, and Spain, providing multiple locations for potential participation. The study focuses on combining targeted immunotherapy with radiation therapy, specifically investigating mogamulizumab alongside Total Skin Electron Beam therapy. This trial represents an opportunity for patients who have already received at least one previous systemic treatment and are looking for alternative treatment options. The multi-country approach suggests a coordinated European effort to advance treatment options for this rare form of cancer.
