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Study of brentuximab vedotin for maintenance therapy in patients with cutaneous T-cell lymphoma after stem cell transplant

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on patients with Cutaneous T-cell Lymphomas (CTCL), specifically Mycosis Fungoides, which is a rare type of skin lymphoma. The study evaluates the effectiveness of Brentuximab vedotin (also known as ADCETRIS) compared to placebo in patients who have recently undergone allogeneic hematopoietic stem cell transplantation (a procedure where a patient receives blood-forming stem cells from a donor).

The purpose of the study is to determine if Brentuximab vedotin can help prevent the lymphoma from returning or progressing after transplantation. The medication or placebo will be given through intravenous infusion, which means it will be administered directly into a vein. The treatment will continue for approximately 45 weeks.

During the study, patients will receive either Brentuximab vedotin or placebo as a maintenance treatment. The medication is provided as a solution for infusion that is prepared from a powder concentrate. Patients will be monitored for two years to assess how well the treatment works in preventing the disease from returning or getting worse.

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

    Initial evaluation

    Your eligibility for the study will be confirmed after diagnosis of cutaneous T-cell lymphoma (CTCL) with specific stage requirements

    The medical team will verify that you have received stem cell transplant within the previous 60-90 days

    You must be between 18 and 70 years old and have shown response to previous treatments

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either brentuximab vedotin or placebo

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    Treatment administration

    You will receive treatment through intravenous infusion

    The medication (either brentuximab vedotin or placebo) will be administered in solution form

    Regular visits will be scheduled for treatment administration

  4. Step 4

    Monitoring and assessment

    Your condition will be regularly monitored for disease progression over 2 years

    Quality of life assessments will be conducted using specific questionnaires

    Skin samples may be taken at the start, after 3 months, and if the disease progresses

    Your body's response to the transplant will be monitored, including potential complications

  5. Step 5

    Long-term follow-up

    Your overall survival and health status will be tracked

    Regular evaluations will continue until the study ends in September 2032

    Quality of life assessments will continue for 2 years after starting treatment

Who can join the trial?

7 criteria

  • Must be between 18 and 70 years old
  • Must have a confirmed diagnosis of mycosis fungoides (a type of skin lymphoma) at stages IIB, III, IVA, or IVB, with at least 1% of cells showing CD30 protein on their surface
  • Must have previously received at least one systemic treatment (treatment that affects the whole body) that either didn't work or the disease came back
  • Must show either complete or partial improvement in lymphoma symptoms when entering the study
  • Must have recently received a stem cell transplant (called alloHSCT) from a compatible donor between 60 to 90 days before joining the study. The donor can be a sibling or another matched donor
  • Must have active life insurance coverage
  • Must provide written consent to participate in the study

Who cannot join the trial?

15 criteria

  • History of allergic reactions to similar medications or their ingredients
  • Participation in other clinical trials within the last 30 days
  • Pregnancy or breastfeeding
  • Serious heart, liver, or kidney conditions that are not well controlled
  • Active infections requiring treatment
  • History of other cancers in the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Mental conditions that could interfere with following study procedures
  • Use of medications that could interact with the study drug
  • Inability to follow study procedures or attend scheduled visits
  • Major surgery planned during the study period
  • Life expectancy less than 3 months
  • Drug or alcohol abuse within the past year
  • Abnormal blood test results that suggest serious health issues
  • Immune system disorders that are not related to the main condition being studied
  • Unable to give informed consent
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Investigated drugs

Brentuximab vedotin is a medication used to treat certain types of lymphoma (cancer of the lymphatic system). It works by targeting specific proteins on cancer cells to help destroy them. In this trial, it is being studied as a maintenance therapy for patients who have received an allogeneic hematopoietic stem cell transplant (a procedure where a patient receives blood-forming stem cells from a donor) for cutaneous T-cell lymphomas, which are cancers that affect the skin.

What is already known about the treatment

Brentuximab vedotin - An injectable antibody-drug conjugate medication that specifically targets CD30-positive lymphoma cells, primarily used in the treatment of cutaneous T-cell lymphomas (CTCL) and other rare lymphatic cancers. The drug works by delivering a potent anti-cancer agent directly to cancer cells expressing the CD30 protein on their surface, causing cell death while minimizing damage to healthy tissues. Currently well-established in medical practice, it is being studied as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (alloHSCT) to prevent disease progression in CTCL patients, representing an important advancement in targeted cancer therapy.

Investigated diseases

  • Graft-versus-host disease (GVHD)

    A condition that occurs after bone marrow transplantation where the donor's immune cells attack the recipient's tissues. GVHD can develop in two forms: acute, which typically occurs within 100 days after transplant, and chronic, which develops later. The condition primarily affects the skin, liver, and digestive system. The immune cells from the donor recognize the recipient's body as foreign and launch an immune response against these tissues.

  • Cutaneous T-cell lymphoma

    A rare type of cancer that begins in white blood cells called T-cells and primarily affects the skin. The disease causes red, scaly patches or thickened plaques of skin that may be itchy. As it progresses, these skin lesions can become more widespread across the body. The condition develops slowly, often starting with dry, itchy patches that can be mistaken for other skin conditions.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521093-34-00Protocol code2025-521093-34-00Estimated enrolment84 patientsSponsorAssistance Publique Hopitaux De Paris

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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).