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Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression

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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 called Peripheral T-cell Lymphoma (PTCL). The study is investigating a treatment combination that includes several medications: Brentuximab Vedotin, Doxorubicin Hydrochloride, Cyclophosphamide, and Prednisone. These medications are used to treat cancer by targeting and killing cancer cells. The purpose of the study is to evaluate how well this combination works in treating PTCL, especially in cases where the cancer cells have less than 10% of a protein called CD30.

Participants in the study will receive the treatment over a period of six months. The treatment involves receiving the medications through an intravenous infusion, which means the drugs are given directly into a vein, and in the case of prednisone, it is taken orally as a tablet. The study is designed to observe the response of the cancer to the treatment and to monitor any side effects that may occur. The study will also look at how long the treatment keeps the cancer from getting worse and the overall survival of the participants.

The study is open-label, meaning both the researchers and participants know which treatment is being given. It is divided into two groups, or cohorts, to better understand the effects of the treatment. The results will be reviewed by independent experts to ensure accuracy. This study aims to provide valuable information on the effectiveness of this treatment combination for people with PTCL, potentially leading to improved treatment options in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit with the medical team. During this visit, you will receive detailed information about the study, including the treatment plan and schedule.

    You will be asked to provide written consent to participate in the study. If you are unable to provide consent, a legally authorized representative may do so on your behalf.

  2. Step 2

    Treatment cycle 1

    The treatment involves a combination of medications administered in cycles. Each cycle lasts for a specific period, followed by a rest period.

    You will receive doxorubicin hydrochloride and cyclophosphamide through an intravenous infusion. This means the medication will be given directly into your vein.

    You will also receive brentuximab vedotin through intravenous administration.

    Additionally, you will take prednisone tablets orally. The dosage and frequency will be determined by your medical team.

  3. Step 3

    Subsequent treatment cycles

    You will continue to receive the same combination of medications in subsequent cycles. The number of cycles will be determined by your medical team based on your response to the treatment.

    Regular monitoring and assessments will be conducted to evaluate your progress and adjust the treatment plan if necessary.

  4. Step 4

    Follow-up visits

    After completing the treatment cycles, you will have follow-up visits with the medical team. These visits are important to monitor your health and the effectiveness of the treatment.

    During these visits, additional tests and assessments may be conducted to ensure your well-being.

Who can join the trial?

26 criteria

  • Must be 18 years or older.
  • Must have a type of cancer called Peripheral T-cell Lymphoma (PTCL), but not a subtype called sALCL.
  • Must have one of the following PTCL subtypes:
    • PTCL - not otherwise specified (PTCL-NOS)
    • Angioimmunoblastic T-cell lymphoma (AITL)
    • Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)
    • Enteropathy-associated T-cell lymphoma (EATL)
    • Hepatosplenic T-cell lymphoma
    • Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
    • Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
    • Follicular T-cell lymphoma
    • Nodal PTCL with T-follicular helper (TFH) phenotype
    • Must have CD30 expression less than 10% in a tumor sample.
    • Must have a type of disease that shows up on a scan called PET and can be measured by a CT scan to be at least 1.5 cm.
    • Must have an ECOG performance status of 2 or less, which means you are able to carry out all self-care but unable to carry out any work activities.
    • Must have certain blood test results within specific limits:
      • Bilirubin level 1.5 times the upper limit of normal or 3 times for those with Gilbert's disease or liver involvement with lymphoma.
      • ALT and AST levels 3 times the upper limit of normal or 5 times for those with liver involvement with lymphoma.
      • Serum creatinine level 2 times the upper limit of normal.
      • Estimated glomerular filtration rate (eGFR) greater than 45 mL/min/1.73 m².
      • Absolute neutrophil count (ANC) of at least 1000/µL unless there is bone marrow involvement with lymphoma.
      • Platelet count of at least 50,000/µL unless there is bone marrow involvement with lymphoma.
      • If HIV-positive, must meet these conditions:
        • CD4+ T-cell count of at least 350 cells/µL within 28 days of starting the study.
        • No AIDS-defining infections in the past 12 months.
        • On stable HIV treatment for at least 4 weeks with a viral load less than 400 copies/mL within 28 days of starting the study.
        • Males with partners who can become pregnant must agree to use effective birth control during the study and for a certain period after the last dose of treatment.
        • Females who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for a certain period after the last dose of treatment.
        • Must provide written informed consent to participate in the study. If unable to provide consent, a legally authorized representative can do so, but the participant must provide consent later if able.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer besides Peripheral T-cell Lymphoma cannot participate.
  • Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
  • Patients who have received any other treatment for cancer within the last 4 weeks cannot participate.
  • Patients with uncontrolled or serious infections cannot participate.
  • Patients with significant heart problems cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to the study medication cannot participate.
  • Patients who have participated in another clinical trial within the last 4 weeks cannot participate.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate cannot participate.
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Investigated drugs

  • Brentuximab Vedotin

    is a type of medication used in cancer treatment. It works by attaching to a specific protein found on the surface of some cancer cells. Once attached, it releases a substance that helps to kill these cancer cells. In this trial, it is being used to treat a type of cancer called peripheral T-cell lymphoma.

  • CHP

    is a combination of three different chemotherapy drugs used together to treat cancer. These drugs work by stopping the growth of cancer cells, which helps to shrink tumors and slow down the progression of the disease. In this trial, CHP is used alongside brentuximab vedotin to treat peripheral T-cell lymphoma.

What is already known about the treatment

Brentuximab vedotin – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. Currently, brentuximab vedotin is being studied in clinical trials for its effectiveness in treating peripheral T-cell lymphoma, a type of cancer affecting the immune system. It works by targeting a specific protein on the surface of cancer cells, delivering a toxic substance that helps to kill these cells. Brentuximab vedotin is classified as an antibody-drug conjugate, which combines an antibody with a drug to specifically target and destroy cancer cells.

Investigated diseases

Peripheral T-cell Lymphoma – Peripheral T-cell Lymphoma is a type of non-Hodgkin lymphoma that originates from mature T-cells. It involves the abnormal growth of T-cells, which are a type of white blood cell crucial for the immune response. The disease often presents with symptoms such as swollen lymph nodes, fever, and weight loss. As it progresses, it can affect various parts of the body, including the skin, liver, and bone marrow. The disease is characterized by its aggressive nature and can vary significantly in its presentation and progression. It is known for its diverse subtypes, each with unique clinical features.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509155-14-00Protocol codeC5691004 / SGN35-032Estimated enrolment113 patientsSponsorSeagen Inc.

sourced from the EU Clinical Trials Register and site verification

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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).