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Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called cutaneous T-cell lymphoma, which affects a kind of white blood cell and primarily involves the skin. The study specifically looks at two subtypes of this cancer: Mycosis Fungoides and Sézary Syndrome. The treatment being tested in this trial is a medication called mogamulizumab, also known by its code names KW-0761 and AMG 761. This medication is being used in combination with a treatment method called Total Skin Electron Beam therapy (TSEB), which involves using a special type of radiation to treat the skin.

The purpose of the study is to evaluate how well this combination treatment works in patients with stage IB to IIB cutaneous T-cell lymphoma. Participants in the study will receive the treatment and be monitored over a period of time to see how their cancer responds. The study will look at various outcomes, including how long patients live without their cancer getting worse, the overall safety of the treatments, and the response rate, which measures how many patients experience a reduction in their cancer.

Throughout the study, researchers will also assess other factors such as the overall survival of patients, the time it takes for the cancer to progress, and the duration of any positive response to the treatment. Additionally, the study will explore the impact of the treatment on patients' quality of life. The trial is designed to gather important information that could help improve treatment options for people with this type of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, stage of the condition, and previous treatments.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the condition and overall health.

    This assessment includes a review of medical history and a physical examination.

  3. Step 3

    Treatment phase

    The treatment involves the administration of mogamulizumab, an anti-CCR4 monoclonal antibody, through an intravenous route.

    The treatment is combined with Total Skin Electron Beam therapy (TSEB).

    The duration and frequency of the treatment are determined by the study protocol and are aimed at evaluating the progression-free survival rate over 48 weeks.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to the treatment and any side effects.

    Follow-up visits are scheduled to evaluate the overall safety and effectiveness of the treatment.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the progression-free survival rate at 48 weeks.

    Secondary outcomes include overall safety, response rate, overall survival, and quality of life assessments.

Who can join the trial?

5 criteria

  • Participants must be **male or female** and **18 years or older**.
  • Participants must have a specific type of skin cancer called **Mycosis Fungoides** at stages **IB, IIA, or IIB**.
  • Participants must have tried at least one previous treatment that affects the whole body, except for a treatment called **Psoralen plus ultraviolet light therapy (PUVA)**, which does not count.
  • Participants must have **adequate haematological and organ function**, meaning their blood and organs are working well enough.
  • Participants must provide a **signed informed consent**, which means they agree to join the study after understanding what it involves.

Who cannot join the trial?

9 criteria

  • Patients who have other types of cancer besides the specific skin-related cancer being studied.
  • Patients who have serious infections that are not well controlled.
  • Patients who have a history of severe allergic reactions to similar treatments.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have certain heart conditions that are not stable.
  • Patients who have liver or kidney problems that are severe.
  • Patients who have a history of drug or alcohol abuse that could affect the study.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

  • Mogamulizumab

    is a type of medication known as a monoclonal antibody. It is designed to target and bind to a specific protein called CCR4, which is found on the surface of certain cancer cells. By attaching to this protein, mogamulizumab can help the immune system recognize and destroy these cancer cells. In this trial, it is being used to treat patients with a type of skin cancer called cutaneous T-cell lymphoma.

  • Total Skin Electron Beam Therapy (TSEB)

    is a form of radiation therapy that is used to treat the entire surface of the skin. It involves directing a beam of electrons at the skin to kill cancer cells. This therapy is often used for skin conditions like cutaneous T-cell lymphoma, as it can effectively target cancer cells while minimizing damage to deeper tissues. In this trial, TSEB is combined with mogamulizumab to enhance the treatment's effectiveness.

What is already known about the treatment

Mogamulizumab – This medication is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating cutaneous T-cell lymphoma, including Mycosis Fungoides and Sézary Syndrome. It is a monoclonal antibody that targets the CCR4 receptor on certain cancerous T-cells, helping the immune system to identify and destroy these cells. Mogamulizumab is classified as an immunotherapy agent and is being evaluated for its ability to improve progression-free survival in patients with specific stages of this lymphoma.

Investigated diseases

Cutaneous T-cell lymphoma – This is a type of cancer that affects T-lymphocytes, a kind of white blood cell, and primarily involves the skin. It often begins with patches or plaques on the skin that may be itchy or scaly. Over time, it can progress to form tumors or spread to other parts of the body, including lymph nodes and internal organs. The disease can vary greatly in its progression, with some cases remaining stable for years and others advancing more rapidly. It is considered a rare disease and includes subtypes such as Mycosis Fungoides and Sézary Syndrome. These subtypes may present with additional symptoms like enlarged lymph nodes or circulating cancerous cells in the blood.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502434-10-00Protocol codeEORTC-1820-CLTFEstimated enrolment43 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).