Study on the Safety of Mogamulizumab for Patients with Relapsed or Refractory Mycosis Fungoides or Sézary Syndrome

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What is this study about?

This clinical trial is focused on studying a type of cancer called Cutaneous T-Cell Lymphoma (CTCL), specifically the subtypes known as Mycosis Fungoides and Sézary Syndrome. These are rare forms of cancer that affect the skin. The treatment being tested in this study is a medication called Mogamulizumab, which is also known by its code names KW-0761 and AMG 761. This medication is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and tolerability of Mogamulizumab when given every four weeks to participants whose cancer has returned or has not responded to previous treatments. Participants will receive the medication over a period of up to 24 weeks. During the study, researchers will monitor participants for any side effects and changes in their health, including laboratory tests and physical examinations.

This study aims to gather important information about how the body responds to Mogamulizumab and to understand its effects on the cancer. The study will also look at how the medication is processed in the body and whether the immune system produces any antibodies against it. This information will help determine the potential benefits and risks of using Mogamulizumab for treating Cutaneous T-Cell Lymphoma.

1 joining the study

Upon joining the study, the participant will have signed an informed consent form. This document confirms understanding of the study and agreement to participate.

Eligibility is confirmed through a series of assessments, including age, medical history, and previous treatments for cutaneous T-cell lymphoma (CTCL).

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of mycosis fungoides or Sézary syndrome, which are subtypes of CTCL.

The participant’s overall health status is evaluated, including blood tests to check liver and kidney function, and a pregnancy test for women of childbearing potential.

3 treatment initiation

The treatment involves the administration of mogamulizumab, a medication given as an intravenous injection.

The initial phase includes more frequent dosing to establish the treatment’s effectiveness and safety.

4 ongoing treatment

After the initial phase, mogamulizumab is administered every four weeks.

The participant will continue to receive this treatment as long as it is deemed beneficial and safe.

5 monitoring and follow-up

Regular monitoring is conducted to assess the participant’s response to the treatment. This includes physical examinations, blood tests, and other necessary evaluations.

The study aims to observe any side effects and changes in health status, ensuring the participant’s safety throughout the trial.

6 completion of the study

The study is expected to conclude by September 30, 2025.

Upon completion, a final assessment will be conducted to evaluate the overall impact of the treatment on the participant’s condition.

Who Can Join the Study?

You must voluntarily sign and date an approved informed consent form before any study-related procedures begin.
You must be 18 years of age or older.
You must have a confirmed diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS), which are specific types of skin conditions.
You must have tried at least one previous treatment for your condition that did not work. This could include treatments like interferon, bexarotene, or chemotherapy. A treatment called psoralen plus UVA is not considered a systemic therapy.
You must have a performance status score of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
Any side effects from previous cancer treatments must be mild or resolved.
Your blood health must be adequate, meaning you have enough white blood cells and platelets.
Your liver function must be adequate, with specific levels of liver enzymes and bilirubin.
Your kidney function must be adequate, with a creatinine clearance of at least 30 mL/min.
If you have been treated with certain antibodies before, you can still participate if your CD4+ cell counts are at least 200/mm³.
If you have a history of a specific type of bacterial infection, you can participate if you are on stable doses of preventive antibiotics.
If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study medication.
If you are a woman who can become pregnant, you must agree to use effective birth control methods during the study and for 6 months after the last dose. This includes methods like oral contraceptives or a double barrier method (such as a condom plus spermicide).

Who Cannot Join the Study?

Patients who have a different type of cancer that is not mycosis fungoides or Sézary syndrome. These are specific types of skin lymphoma.
Patients who are currently receiving other treatments for their cancer that might interfere with the study medication.
Patients who have a serious infection that is not well controlled. This means the infection is not being managed effectively with treatment.
Patients who have a history of severe allergic reactions to similar medications. An allergic reaction is when the body reacts negatively to a substance.
Patients who are pregnant or breastfeeding. This is to ensure the safety of the unborn baby or nursing child.
Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	16.08.2021
Spain	Not recruiting	16.08.2021

Trial locations

Investigated drugs:

Mogamulizumab

Mogamulizumab is a medication being studied for its safety and tolerability in patients with certain types of skin lymphoma, specifically mycoses fungoides and Sézary syndrome. It is given to patients who have not responded to previous treatments or whose cancer has returned. The study involves administering this medication every four weeks to see how well patients tolerate it and to monitor any side effects.

Mycosis Fungoides – This is a type of cutaneous T-cell lymphoma, which is a cancer that starts in the white blood cells and affects the skin. It often begins with skin patches that may be red, scaly, and itchy. Over time, these patches can thicken into plaques or tumors. The disease can progress slowly, and in some cases, it may spread to other parts of the body, including the lymph nodes and internal organs. The progression can vary greatly among individuals, with some experiencing only mild skin symptoms for many years.

Sézary Syndrome – This is a rare form of cutaneous T-cell lymphoma characterized by the presence of cancerous T-cells in the blood. It typically presents with widespread skin redness, itching, and scaling, along with enlarged lymph nodes. Unlike mycosis fungoides, Sézary syndrome involves both the skin and the blood from the onset. The disease can lead to significant discomfort due to skin symptoms and may progress to involve other organs. The course of the disease can be variable, with some patients experiencing more aggressive progression.

Trial ID:

2024-515921-27-00

Protocol code:

0761-016

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Mogamulizumab for Patients with Relapsed or Refractory Mycosis Fungoides or Sézary Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?