Ongoing Clinical Trials for Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma is a rare type of cancer that begins in white blood cells called T-cells and primarily affects the skin. Currently, there are 6 ongoing clinical trials exploring different treatment options for patients with this condition. These trials are being conducted across multiple European countries and are testing various medications, including mogamulizumab, brentuximab vedotin, lacutamab, linperlisib, tolinapant, and tofacitinib. The trials focus on patients at different stages of the disease and include those whose cancer has returned or not responded to previous treatments.
Clinical trial locations
- Belgium
- Denmark
- France
- Study of brentuximab vedotin for maintenance therapy in patients with cutaneous T-cell lymphoma after stem cell transplant
- Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma
- Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
- Germany
- Greece
- Italy
- Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma
- Study of Linperlisib for Patients with Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma
- Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
- Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas
- Poland
- Spain
- Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma
- Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
- Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas
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 stage IB to IIB disease, including specific subtypes called Mycosis Fungoides and Sézary Syndrome. The treatment combines a medication called mogamulizumab with Total Skin Electron Beam therapy (TSEB), a special type of radiation treatment that targets the skin.
Who can participate: Patients must be 18 years or older with Mycosis Fungoides at stages IB, IIA, or IIB. They must have tried at least one previous treatment that affects the whole body, though Psoralen plus ultraviolet light therapy does not count. Participants need to have adequate blood counts and organ function, and must provide signed informed consent.
Who cannot participate: The trial excludes patients with other types of cancer besides the specific skin-related cancer being studied, those with serious uncontrolled infections, a history of severe allergic reactions to similar treatments, pregnant or breastfeeding women, and those who have participated in another clinical trial within the last 30 days. Patients with unstable heart conditions, severe liver or kidney problems, or a history of drug or alcohol abuse are also excluded.
What the trial aims to achieve: The main goal is to evaluate how long patients live without their cancer getting worse over a 48-week period. Researchers will also assess the overall safety of the treatments, how many patients experience a reduction in their cancer, overall survival rates, and the impact on patients’ quality of life.
Treatment details: Mogamulizumab is a monoclonal antibody that targets a specific protein called CCR4 found on certain cancer cells. By attaching to this protein, it helps the immune system recognize and destroy these cancer cells. This medication is administered through an intravenous infusion and is combined with TSEB, which uses a beam of electrons to target cancer cells across the entire skin surface while minimizing damage to deeper tissues.
Study of brentuximab vedotin for maintenance therapy in patients with cutaneous T-cell lymphoma after stem cell transplant
This trial focuses on patients with Mycosis Fungoides who have recently undergone allogeneic hematopoietic stem cell transplantation, a procedure where patients receive blood-forming stem cells from a donor. The study compares brentuximab vedotin with placebo as a maintenance treatment to help prevent the cancer from returning.
Who can participate: Patients must be between 18 and 70 years old with confirmed Mycosis Fungoides at stages IIB, III, IVA, or IVB. They must have at least 1% of cells showing CD30 protein on their surface and have previously received at least one systemic treatment that either didn’t work or the disease returned. Participants must show either complete or partial improvement when entering the study and must have received a stem cell transplant from a compatible donor between 60 to 90 days before joining. Active life insurance coverage and written consent are also required.
Who cannot participate: The trial excludes those with a history of allergic reactions to similar medications, participation in other trials within 30 days, pregnancy or breastfeeding, serious uncontrolled heart, liver, or kidney conditions, active infections requiring treatment, and history of other cancers in the past 5 years (except successfully treated non-melanoma skin cancer). Those with mental conditions interfering with study procedures, inability to follow study requirements, planned major surgery during the study, life expectancy less than 3 months, recent drug or alcohol abuse, abnormal blood test results suggesting serious health issues, or immune system disorders unrelated to the main condition are also excluded.
What the trial aims to achieve: The primary goal is to determine if brentuximab vedotin can prevent the lymphoma from returning or progressing after transplantation. Patients will be monitored for two years to assess disease progression, quality of life, and the body’s response to the transplant, including potential complications.
Treatment details: Brentuximab vedotin is an antibody-drug conjugate that specifically targets CD30-positive lymphoma cells. It delivers a potent anti-cancer agent directly to cancer cells, causing cell death while minimizing damage to healthy tissues. The medication is administered through intravenous infusion as a solution prepared from powder concentrate, with treatment continuing for approximately 45 weeks.
Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma
This trial studies the effectiveness of lacutamab (also known as IPH4102), a monoclonal antibody designed to target and attack cancer cells. The study explores the effects of lacutamab when used alone or in combination with chemotherapy for patients with advanced forms of T-cell lymphoma.
Who can participate: Patients with Sézary Syndrome must have stage IVA or IVB disease that has returned or not responded to treatment and have tried at least two different treatments, including mogamulizumab. They must have a certain level of cancer cells in their blood confirmed by flow cytometry. Patients with Mycosis Fungoides must have stage IB, IIA, IIB, III, or IV disease that has returned or not responded to treatment and have tried at least two different treatments. For those in specific study groups, their skin must show a certain protein called KIR3DL2 in at least one skin lesion. All participants must be at least 18 years old, able to have at least one skin sample taken, have adequate blood counts and organ function, and wait at least 3 weeks after their last treatment before starting the study.
Who cannot participate: The trial excludes patients with other types of cancer not being studied, those who have not experienced a return or worsening of their T-cell lymphoma after treatment, serious uncontrolled infections, significant heart problems, pregnancy or breastfeeding, inability to follow study procedures, recent participation in another clinical trial, history of severe allergic reactions to similar treatments, certain autoimmune diseases, and severe liver or kidney problems.
What the trial aims to achieve: The study evaluates how well patients respond to lacutamab treatment by measuring the proportion of patients with a complete or partial response. Safety assessments monitor for adverse events, changes in laboratory evaluations, and vital signs. Quality of life is assessed using questionnaires and a scale for itching. Researchers collect information on how treatment affects participants’ overall health and well-being.
Treatment details: Lacutamab is a monoclonal antibody that targets a specific receptor on cancer cells, helping the immune system identify and destroy them. It is administered as an intravenous infusion. Some participants may receive a placebo for comparison purposes. The study requires a minimum wash-out period of 3 weeks between the last dose of any prior systemic therapy and the first dose of lacutamab.
Study of Linperlisib for Patients with Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma
This trial studies the effectiveness and safety of linperlisib (also known as YY-20394) in treating lymphomas that have returned after treatment or have not responded to previous treatments. The trial is designed for patients whose cancer affects either the lymph nodes or the skin.
Who can participate: Patients must be 18 years or older with a confirmed diagnosis of specific types of lymphoma. For those with disease affecting the skin, they must have measurable disease defined by specific criteria, such as certain blood tests or a score greater than 0 on a specific assessment tool. Participants must have an ECOG performance status of 0 to 1, meaning they are fully active or have some symptoms but don’t require bed rest. They must have adequate organ function, including specific blood counts, liver and kidney function, and heart function. Patients must have received and failed at least one line of systemic therapy (or two lines for certain stages). They must be willing to provide tumor tissue samples or undergo a biopsy before treatment and agree to use effective contraception during treatment and for at least 3 months afterward.
Who cannot participate: The trial excludes patients who have not recovered from previous treatments, those with other active cancers not the focus of this study, severe heart problems, uncontrolled infections, pregnancy or breastfeeding, known allergies to the study medication, participation in another clinical trial within the last 4 weeks, history of certain autoimmune diseases, severe liver or kidney disease, and history of drug or alcohol abuse.
What the trial aims to achieve: The study evaluates the objective response rate, which measures the proportion of patients with a complete or partial response to treatment. It also assesses safety by monitoring for adverse events, changes in laboratory evaluations, and vital signs throughout the study period.
Treatment details: Linperlisib is taken orally in tablet form. It works by targeting specific pathways in cancer cells, which may help stop their growth and spread. It belongs to a class of drugs known as PI3K inhibitors, which interfere with the signaling pathways that cancer cells use to survive and multiply. Patients will be closely monitored throughout the treatment period with regular check-ups and tests.
Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas
This trial studies the effects of tolinapant (also known as ASTX660) in patients with advanced forms of cancer, including various types of lymphomas. The study is aimed at cancers that have either spread to other parts of the body or cannot be removed through surgery.
Who can participate: Patients must be 18 years or older and able to understand and follow study procedures. They must have advanced solid tumors or lymphoma that cannot be removed by surgery or has spread, and for which no standard treatments are available. For certain study groups, participants must have a specific type of T-cell lymphoma confirmed by pathology report, show evidence of disease progression, and have received at least two previous treatments. They must have measurable disease according to specific criteria and an ECOG performance status of 0, 1, or 2, indicating their level of daily functioning. Acceptable organ function must be shown through specific laboratory tests. Women who can become pregnant must have a negative pregnancy test, and both women and men must agree to use two effective methods of birth control during the study and for at least three months after treatment ends.
Who cannot participate: The trial excludes patients with other types of cancer not included in the study, those who have not recovered from previous cancer treatments, serious heart problems, uncontrolled infections, pregnancy or breastfeeding, another cancer within the last 3 years (except certain skin cancers or very early stage cervical cancer), known allergies to the study drug or similar drugs, receipt of another investigational drug within the last 4 weeks, certain serious medical conditions that could interfere with the study, and inability to follow study procedures.
What the trial aims to achieve: The primary goal is to evaluate the safety and effectiveness of tolinapant in reducing the size of tumors or slowing their growth. The study aims to determine the best dose of tolinapant and gather information on how the body processes the medication. Participants will be monitored for any side effects and changes in their condition throughout the study.
Treatment details: Tolinapant is taken orally in capsule form. It works by inhibiting specific proteins that help cancer cells survive, thereby promoting cancer cell death. It is classified as a small molecule inhibitor. Some participants may receive a placebo to compare the effects of tolinapant. The study is expected to continue until the end of 2025.
Study on Tofacitinib for Patients with Mycosis Fungoides
This trial is testing a medication called Xeljanz, which contains the active ingredient tofacitinib, for patients with Mycosis Fungoides. This is an open-label pilot study, meaning both researchers and participants know what treatment is being administered, and it’s designed to gather preliminary data.
Who can participate: Patients must be 18 years or older with a confirmed diagnosis of Mycosis Fungoides at stages IA, IIA, or IIB. They must have stable disease, meaning the condition is not getting worse, and no change in medication for 2 months or 5 half-lives before entering the study. Participants must have received the yearly flu vaccine and recommended COVID-19 vaccines. Adequate blood counts are required, including absolute neutrophil count greater than or equal to 1,000 per microliter, platelets greater than or equal to 100,000 per microliter, and hemoglobin level greater than or equal to 5.5 mmol/L. Liver and kidney function tests must show ALT less than or equal to 2.5 times the normal limit, serum-creatinine less than or equal to 1.5 times the normal limit, and bilirubin level less than or equal to 1.5 times the normal limit. Negative tests for tuberculosis, HIV, hepatitis B, and C are required. 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.
Who cannot participate: The trial excludes patients with a history of severe allergic reactions to the study medication, those currently pregnant or breastfeeding, individuals with other serious health conditions that might interfere with the study, those who have used certain medications recently that could affect study results, history of substance abuse or addiction, participation in another clinical trial within a certain time frame, and anyone who cannot comply with study procedures or follow-up visits.
What the trial aims to achieve: The study aims to see if treatment with Xeljanz can decrease disease activity. It will observe how the disease responds to treatment over time, looking for changes such as complete response, partial response, stable disease, or progressive disease. The overall response rate to treatment will be evaluated, and the study will explore the effects on the tumor microenvironment and skin barrier deficiency.
Treatment details: Tofacitinib is taken orally as a 10 mg film-coated tablet. It works by blocking certain enzymes in the body known as JAK1 and JAK3, which are involved in the immune response. By inhibiting these enzymes, the medication may help decrease inflammation and improve symptoms. Patients will be monitored regularly throughout the study for disease activity and any side effects.
Summary
The six ongoing clinical trials for cutaneous T-cell lymphoma represent a diverse approach to treating this rare cancer. The trials are spread across several European countries, with France, Italy, and Spain showing the highest concentration of studies. Most trials focus on patients whose disease has returned after treatment or has not responded to previous therapies, highlighting the need for new treatment options for advanced cases.
The investigational medications being tested work through different mechanisms. Several trials examine targeted therapies like monoclonal antibodies (mogamulizumab, brentuximab vedotin, and lacutamab) that specifically target proteins on cancer cells. Other studies explore newer approaches, including PI3K inhibitors (linperlisib) and JAK inhibitors (tofacitinib). One notable trial combines medication with radiation therapy, using Total Skin Electron Beam therapy alongside mogamulizumab.
The trials vary in their focus, with some specifically targeting Mycosis Fungoides subtypes at particular stages, while others include broader patient populations. One unique trial examines maintenance therapy following stem cell transplantation, addressing the important question of preventing cancer recurrence after this intensive treatment. The availability of these trials across multiple countries provides European patients with various options for accessing innovative treatments, though eligibility requirements differ significantly between studies.
