Study on Tofacitinib for Patients with Mycosis Fungoides

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mycosis Fungoides, which is a form of skin lymphoma. The study is testing a medication known as Xeljanz, which contains the active ingredient tofacitinib. Tofacitinib is a chemical substance that works by inhibiting certain proteins in the body, specifically JAK1 and JAK3, which are involved in the immune response. The purpose of the study is to see if treatment with Xeljanz can decrease the activity of the disease.

Participants in the study will take Xeljanz in the form of film-coated tablets, which are taken orally. The study will observe how the disease responds to the treatment over a period of time, looking for changes such as complete response, partial response, stable disease, or progressive disease. The overall response rate to the treatment will also be evaluated. The study is open-label, meaning that both the researchers and participants know what treatment is being administered.

This trial is a pilot study, which means it is an initial, smaller-scale study designed to gather preliminary data. It aims to explore the effects of Xeljanz on the tumor microenvironment and skin barrier deficiency in patients with Mycosis Fungoides. The study will help determine if further research is warranted and provide insights into the potential benefits of using Xeljanz for this condition.

1 joining the study

Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must meet specific criteria, such as being 18 years or older, having a confirmed diagnosis of mycosis fungoides, and having stable disease. You must also have received the yearly flu vaccine and COVID-19 recommended vaccines.

2 initial assessment

An initial assessment will be conducted to ensure you meet all the necessary health criteria. This includes checking your blood levels, such as alanine transaminase (ALT), serum-creatinine, and bilirubin levels, among others.

Tests will be conducted to confirm negative results for tuberculosis, HIV, hepatitis B, and C.

3 medication administration

You will begin taking the medication Xeljanz, which is a 10 mg film-coated tablet. This medication is taken orally.

The dosage and frequency will be determined by the study protocol, and you will be informed of the exact schedule.

4 ongoing monitoring

Throughout the study, your health and response to the medication will be monitored regularly. This includes evaluating your disease activity and any side effects.

You will be required to attend scheduled visits for assessments and to provide updates on your condition.

5 end of study

The study is expected to end by December 31, 2024. At the end of the study, a final assessment will be conducted to evaluate your response to the treatment.

You will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Men or women aged 18 or older at the time of consent
Alanine transaminase (ALT) level must be less than or equal to 2.5 times the normal limit set by the institution. ALT is an enzyme found in the liver, and high levels can indicate liver damage.
Serum-creatinine must be less than or equal to 1.5 times the normal limit. Creatinine is a waste product in the blood that comes from muscle activity, and high levels can indicate kidney problems.
Negative test for tuberculosis, HIV, hepatitis B, and hepatitis C. These are infections that can affect your immune system and liver.
Women who can have children and men must agree to use safe contraception methods during the study and for at least 4 weeks after stopping treatment.
Must be willing to participate and capable of giving informed consent, which means you understand the study and agree to take part before any study-related procedures begin.
Must have a confirmed diagnosis of Mycosis Fungoides at stages IA, IIA, or IIB. This is a type of skin condition.
Must have a stable disease, meaning the condition is not getting worse.
No change in medication for 2 months or 5 half-lives before entering the study. A half-life is the time it takes for a drug’s active substance to reduce by half in the body.
Must have received the yearly flu vaccine and the recommended COVID-19 vaccines.
Absolute neutrophil count must be greater than or equal to 1,000 per microliter. Neutrophils are a type of white blood cell important for fighting infections.
Platelets must be greater than or equal to 100,000 per microliter. Platelets help with blood clotting.
Hemoglobin level must be greater than or equal to 5.5 mmol/L. Hemoglobin is a protein in red blood cells that carries oxygen.
Bilirubin level must be less than or equal to 1.5 times the normal limit. Bilirubin is a substance made during the normal breakdown of red blood cells, and high levels can indicate liver problems.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to the study medication cannot participate.
Individuals who are currently pregnant or breastfeeding are not eligible.
Patients with other serious health conditions that might interfere with the study are excluded.
Participants who have used certain medications recently that could affect the study results are not allowed.
Individuals with a history of substance abuse or addiction may be excluded.
Patients who have participated in another clinical trial within a certain time frame before this study are not eligible.
Anyone who cannot comply with the study procedures or follow-up visits will be excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.10.2022

Trial locations

Investigated drugs:

Tofacitinib

Xeljanz is a medication used in this clinical trial to see if it can reduce disease activity. It works by blocking certain enzymes in the body known as JAK1 and JAK3. These enzymes are involved in the process that leads to inflammation and immune responses. By inhibiting these enzymes, Xeljanz may help to decrease inflammation and improve symptoms related to the disease being studied. This trial aims to understand if Xeljanz can effectively target the tumor microenvironment and improve skin barrier function, which are important factors in the condition being investigated.

Mycosis Fungoides – Mycosis Fungoides is a type of cutaneous T-cell lymphoma, which is a cancer that starts in the white blood cells and affects the skin. It typically begins with skin patches that may be red, scaly, and itchy, resembling eczema or psoriasis. As the disease progresses, these patches can thicken into plaques and may develop into tumors. In advanced stages, the cancerous cells can spread to other parts of the body, including lymph nodes and internal organs. The progression of the disease can vary greatly among individuals, with some experiencing slow changes over many years, while others may have a more rapid progression.

Trial ID:

2022-500599-79-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Tofacitinib for Patients with Mycosis Fungoides

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