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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Johannes Wesling Klinikum Minden Minden Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Roskilde University Roskilde Denmark
Aapjcwc Orsgqivqaav Urimnylnezcup Cxkugmmvbugz Dtozh Stlhzz E Dskzy Spuhzci Dx Tlfctt Turin Italy
Ksdymlmi dgq Upoarfzgixiv Moiofzxg Ami Munich Germany
Unnotvwmeg Gbfhdoz Hwmcrcqh Acllsxp Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
21.02.2023
France France
Recruiting
21.02.2023
Germany Germany
Recruiting
21.02.2023
Greece Greece
Recruiting
21.02.2023
Italy Italy
Recruiting
21.02.2023
Spain Spain
Recruiting
21.02.2023

Trial locations

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.

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 ID:
2022-502434-10-00
Protocol code:
EORTC-1820-CLTF
NCT ID:
NCT04128072
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study of PTX-100 for Patients with Cutaneous T-Cell Lymphoma That Has Returned or Did Not Respond to Previous Treatment

    Recruiting

    2 1 1
    France Italy
  • Study of brentuximab vedotin for maintenance therapy in patients with cutaneous T-cell lymphoma after stem cell transplant

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France