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Study of Brentuximab Vedotin Combined with R-DHAP Chemotherapy for Patients with Relapsed or Treatment-Resistant CD30-Positive Diffuse Large B-Cell Lymphoma Who Are Eligible for Stem Cell Transplant

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with non-Hodgkin lymphoma, specifically Diffuse large B-cell lymphoma that is CD30 positive. The study examines a treatment combining Brentuximab Vedotin with a chemotherapy regimen called R-DHAP in patients whose disease has either not responded to initial treatment or has returned after previous therapy.

The purpose of this research is to determine the best dose and effectiveness of combining Brentuximab Vedotin with R-DHAP chemotherapy as a second-line treatment. The study is divided into two parts. The first part will establish the appropriate dose of the medication combination, while the second part will evaluate how well the treatment works.

During the study, participants will receive Brentuximab Vedotin through intravenous administration along with R-DHAP chemotherapy. The treatment will be given in cycles, and patients who respond well to the treatment may proceed to receive high-dose chemotherapy followed by autologous stem cell transplantation (a procedure where a patient's own stem cells are used for treatment). The total treatment period may last up to 9 months.

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

    Initial treatment phase

    You will receive a combination treatment called BV-R-DHAP. This includes brentuximab vedotin (BV) together with other medications

    The treatment will be given through an intravenous infusion (directly into your vein)

    You will receive three treatment cycles in total

  2. Step 2

    Treatment monitoring

    After each treatment cycle, your blood counts will be monitored to check recovery

    Your doctor will evaluate any side effects that may occur

    A PET-CT scan (special imaging test) will be performed after the third treatment cycle to check how well the treatment is working

  3. Step 3

    Stem cell collection

    After the second or third treatment cycle, stem cells will be collected from your blood

    These cells will be stored for later use in the transplant

    The collection process aims to gather a specific number of cells needed for successful transplant

  4. Step 4

    Transplant preparation

    If your disease responds to treatment, you will proceed to autologous stem cell transplantation (ASCT)

    ASCT uses your own stem cells that were collected earlier

    You will receive high-dose chemotherapy before the transplant

  5. Step 5

    Post-transplant phase

    Your recovery will be monitored after the transplant

    Another PET-CT scan will be performed to check the treatment results

    You will continue to be monitored for any side effects

  6. Step 6

    Follow-up period

    Regular check-ups will continue to monitor your health status

    Your progress will be tracked until the study ends in February 2027

    The medical team will monitor for any long-term effects of the treatment

Who can join the trial?

17 criteria

  • Must be 18 years or older
  • Must have CD30 positive DLBCL (a type of lymphoma where more than 1% of cells show a specific marker called CD30)
  • Must be suitable for high-dose chemotherapy and stem cell transplant
  • Must have either not responded to first treatment or had the disease return after initial R-CHOP therapy (a combination of cancer medicines)
  • Must have measurable disease showing:
    • At least one abnormal area larger than 1.5 cm on CT scan
    • At least one positive area on PET scan
    • Must have a WHO performance status of 0-2 (ability to perform daily activities)
    • Must have normal liver function
    • Must have normal kidney function
    • Must have adequate bone marrow function
    • Must have hemoglobin level of at least 8 g/dL (blood count can be supported with transfusions)
    • Must have recovered from side effects of previous treatments
    • Must have life expectancy of more than 3 months with treatment
    • Must be able to provide informed consent
    • For women who can become pregnant:
      • Must have negative pregnancy test
      • Must use two effective birth control methods or completely avoid heterosexual intercourse during the study and for 12 months after
      • For men:
        • Must use effective barrier contraception or completely avoid heterosexual intercourse during the study and for 12 months after

Who cannot join the trial?

16 criteria

  • History of severe allergic reactions to any of the study medications
  • Active or chronic hepatitis B (inflammation of the liver caused by hepatitis B virus)
  • Active hepatitis C infection
  • Known HIV infection
  • Serious heart conditions, including:
    • Heart failure
    • Irregular heartbeat that is not controlled by medication
    • Recent heart attack (within 6 months)
    • Active uncontrolled infections requiring treatment
    • Other types of cancer that require treatment (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
    • Severe kidney problems (creatinine clearance less than 50 mL/min)
    • Severe liver problems
    • Nervous system disorders that could interfere with treatment
    • Pregnancy or breastfeeding
    • Unable to use effective contraception during the study and for 12 months after
    • Mental conditions that could affect ability to follow study requirements
    • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

  • Brentuximab Vedotin

    is a targeted cancer medication that attaches to a protein called CD30 found on some lymphoma cells. It delivers a substance that kills cancer cells. This medication is being studied in combination with other treatments for patients with diffuse large B-cell lymphoma.

  • R-DHAP

    is a combination chemotherapy regimen used as a second-line treatment for lymphoma. It consists of rituximab (R) combined with other chemotherapy medications (DHAP) that work together to kill cancer cells. This is commonly used when the first treatment hasn't worked or when the cancer has returned.

  • Rituximab

    is an antibody therapy that targets specific proteins on B-cell lymphoma cells. It helps your immune system identify and destroy these cancer cells. It's being used as part of the R-DHAP combination therapy in this study.

What is already known about the treatment

  • Brentuximab Vedotin

    An antibody-drug conjugate administered through intravenous infusion, specifically designed to target CD30-positive lymphoma cells. This medication works by combining a monoclonal antibody that targets the CD30 protein with a potent chemotherapy agent, delivering the toxic substance directly to cancer cells while minimizing damage to healthy tissue. It is currently approved for treating several types of lymphomas, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and belongs to the class of targeted cancer therapies. The drug has shown significant promise in clinical trials when combined with conventional chemotherapy regimens, particularly as a second-line treatment for patients who haven't responded to initial therapy.

  • R-DHAP

    A combination chemotherapy regimen consisting of rituximab, dexamethasone, high-dose cytarabine, and cisplatin, administered intravenously in cycles. This salvage chemotherapy protocol is commonly used as a second-line treatment for patients with relapsed or refractory non-Hodgkin lymphoma, particularly diffuse large B-cell lymphoma (DLBCL). The regimen works through multiple mechanisms, with rituximab targeting CD20-positive B-cells, while the other components directly interfere with DNA synthesis and cell division in cancer cells. It belongs to the class of combination chemotherapy treatments and is typically used before autologous stem cell transplantation in eligible patients.

Investigated diseases

  • Non-Hodgkin Lymphoma (NHL)

    A group of blood cancers that develop from lymphocytes (white blood cells) in the lymphatic system. It can occur in many different parts of the body, including lymph nodes, spleen, bone marrow, and other organs. The disease develops when lymphocytes begin to multiply abnormally and collect in certain parts of the body. NHL can grow at different rates and can be classified into various subtypes based on how the cells look under a microscope.

  • Diffuse Large B-cell Lymphoma (DLBCL)

    The most common type of non-Hodgkin lymphoma that specifically affects B lymphocytes. It is characterized by large abnormal lymphocytes that have spread diffusely throughout the lymph node or tissue where they are found. The disease typically develops in lymph nodes but can affect other tissues and organs. DLBCL tends to grow quickly in the lymph nodes, causing them to enlarge.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510556-22-00Protocol codeHO136Estimated enrolment36 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

sourced from the EU Clinical Trials Register and site verification

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