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Study of Brentuximab Vedotin with Drug Combination for Untreated CD30-expressing Peripheral T-cell Lymphoma Patients

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as Peripheral T-cell Lymphoma (PTCL), which is a group of rare and aggressive blood cancers. The study is investigating the effectiveness and safety of a treatment combination that includes a medication called Brentuximab Vedotin, also known by its code name SGN-35, along with a chemotherapy regimen referred to as CHEP. The CHEP regimen includes the drugs Etoposide, Doxorubicin, Cyclophosphamide, and Prednisone. These medications are used to target and kill cancer cells.

The purpose of the study is to evaluate how well this combination treatment works in patients who have not been treated before and whose cancer cells express a protein called CD30. The study will involve administering these medications to participants and monitoring their response to the treatment over a period of time. Participants will receive the medications through an intravenous infusion, which means the drugs are delivered directly into the bloodstream through a vein, and in the case of Prednisone, it will be taken orally in tablet form.

Throughout the study, researchers will assess the participants' health and any side effects they may experience. The goal is to determine if the treatment can effectively reduce or eliminate the cancer, as well as to understand any potential risks associated with the treatment. The study will help gather important information that could lead to improved treatment options for patients with this type of cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the patient begins treatment with a combination of medications designed to target CD30-expressing peripheral T-cell lymphomas.

    The treatment includes the following medications: etoposide, doxorubicin, cyclophosphamide, prednisone, and brentuximab vedotin.

  2. Step 2

    Medication administration

    Etoposide, doxorubicin, cyclophosphamide, and brentuximab vedotin are administered intravenously. This means they are given directly into a vein through an infusion.

    Prednisone is taken orally, which means it is swallowed in the form of a pill.

  3. Step 3

    Treatment cycle

    The treatment is organized into cycles. Each cycle includes specific doses of the medications administered over a set period.

    The exact dosage and frequency of each medication are determined by the study protocol and the patient's specific medical condition.

  4. Step 4

    Monitoring and assessment

    Throughout the treatment, the patient's response to the medications is closely monitored.

    Assessments are conducted to evaluate the effectiveness of the treatment and to check for any side effects or adverse reactions.

  5. Step 5

    Completion of treatment

    At the end of the treatment period, a final assessment is conducted to determine the overall response to the therapy.

    The primary goal is to achieve a PET-negative complete response, indicating no detectable cancer activity.

  6. Step 6

    Follow-up period

    After completing the treatment, the patient enters a follow-up period.

    During this time, the patient's health is monitored to ensure long-term safety and to observe any late-emerging effects of the treatment.

Who can join the trial?

12 criteria

  • Must be over 18 years old.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must have a confirmed diagnosis of a specific type of cancer called CD30-expressing PTCL, which includes several subtypes like systemic anaplastic large cell lymphoma and others.
  • Must have a positive CD30 expression, which is a specific marker found in some cancer cells.
  • Must have at least one measurable disease site, meaning a tumor that can be seen and measured using specific imaging tests.
  • Must have a performance status of 0 to 1, which indicates the ability to carry out daily activities without significant limitations.
  • Must be eligible for a procedure called autologous stem cell transplant (ASCT).
  • Must be a suitable candidate for treatment with a type of medication called anthracyclines.
  • Must meet certain laboratory criteria, including specific levels of blood cells and liver and kidney function tests.
  • Females of childbearing potential must not be pregnant or breastfeeding and must agree to use two effective methods of contraception during the study and for 12 months after the last treatment dose.
  • Male participants must agree to use a condom during sexual activity with a woman of childbearing potential during the study and for 6 months after the last treatment dose. Their female partners must also use a highly effective contraception method.
  • Must be able to understand, give written informed consent, and follow all study-related procedures and evaluations.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of cancer cannot participate. Cancer is a disease where cells in the body grow uncontrollably.
  • Patients who are not within the specified age range cannot participate. The age range includes both adults and children.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.
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Investigated drugs

  • Brentuximab Vedotin

    is a medication used in this trial to treat patients with a type of cancer called peripheral T-cell lymphoma. It works by targeting a specific protein found on the surface of cancer cells, helping to destroy them.

  • CHEP

    is a combination of chemotherapy drugs used together to treat cancer. It includes several medications that work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

What is already known about the treatment

Brentuximab Vedotin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, specifically CD30-expressing peripheral T-cell lymphomas. It is an antibody-drug conjugate that targets CD30, a protein found on the surface of some cancer cells, delivering a cytotoxic agent directly to these cells to inhibit their growth. Brentuximab Vedotin is classified as an antineoplastic agent and is being evaluated for its efficacy and safety in combination with other chemotherapy drugs.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors such as genetics and lifestyle. Symptoms can include lumps, unexplained weight loss, fatigue, and changes in skin appearance, among others. Early detection and understanding of the specific type of cancer are crucial for managing its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511567-28-01Protocol codeCLSG-PTCL-CHEPAEstimated enrolment33 patientsSponsorKooperativni Lymfomova Skupina z.s.

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