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Study Comparing Brentuximab Vedotin with Drug Combination for Treating Advanced Classical Hodgkin Lymphoma in Patients

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 is focused on studying a type of cancer called Advanced Classical Hodgkin Lymphoma. The trial is comparing two different treatment combinations to see which one is more effective as a first treatment option for this disease. The first treatment combination includes a medication called brentuximab vedotin (also known by its code name SGN-35) along with three other drugs: doxorubicin, vinblastine, and dacarbazine. This combination is referred to as A+AVD. The second treatment combination includes the same three drugs—doxorubicin, vinblastine, and dacarbazine—plus another drug called bleomycin. This combination is known as ABVD.

The purpose of the study is to compare how well patients do with each treatment combination in terms of how long they live without the disease getting worse. The study is designed to be open-label, meaning both the doctors and the patients know which treatment is being given. Participants in the study will receive their assigned treatment through an intravenous (IV) method, which means the medication is given directly into a vein. The study will last for a period of up to 24 months, during which time the patients will be monitored regularly to assess their response to the treatment.

Throughout the study, the effectiveness of the treatments will be evaluated by looking at how long patients live without their disease progressing, as well as their overall survival. The trial aims to provide valuable information that could help improve treatment options for people with advanced classical Hodgkin lymphoma 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

    Joining the study

    Upon joining the study, the patient is informed about the trial's purpose and procedures. Consent is obtained to ensure understanding and agreement to participate.

    Eligibility is confirmed based on criteria such as age, diagnosis of advanced classical Hodgkin lymphoma, and other health parameters.

  2. Step 2

    Treatment assignment

    The patient is randomly assigned to one of two treatment groups: A+AVD or ABVD.

    The A+AVD group receives brentuximab vedotin (ADCETRIS®) along with doxorubicin, vinblastine, and dacarbazine.

    The ABVD group receives doxorubicin, bleomycin, vinblastine, and dacarbazine.

  3. Step 3

    Treatment administration

    All medications are administered through intravenous use.

    The specific dosages and frequency of administration are determined by the study protocol and the patient's health status.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the patient's response to treatment and to manage any side effects.

    Assessments include physical examinations, blood tests, and imaging studies to evaluate the progression of the disease.

  5. Step 5

    Completion of treatment

    The treatment phase continues as per the study's schedule until the completion of the prescribed cycles.

    Upon completion, the patient's health and response to treatment are thoroughly evaluated.

  6. Step 6

    Follow-up

    After the treatment phase, follow-up visits are scheduled to monitor the patient's long-term health and any potential late effects of the treatment.

    These visits help in assessing the overall survival and progression-free survival of the patient.

Who can join the trial?

14 criteria

  • Male or female patients who are 18 years or older.
  • Patients who have not received treatment for their condition and have advanced Hodgkin Lymphoma, which is a type of cancer affecting the lymphatic system, at Stage III or IV.
  • The diagnosis of classical Hodgkin Lymphoma must be confirmed through a tissue examination, following the guidelines of the World Health Organization.
  • Patients must have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient's daily living abilities, with lower numbers indicating better functioning.
  • Patients must have measurable disease, meaning the cancer can be measured in size using imaging techniques like a CT scan, according to specific criteria for assessing lymphoma.
  • Female patients must either be postmenopausal, surgically sterile, or agree to use two effective methods of birth control or practice true abstinence during the study and for six months after the last dose of the study drug. Male patients must agree to use effective barrier contraception or practice true abstinence during the study and for six months after the last dose of the study drug.
  • Patients must provide voluntary written consent to participate in the study, understanding they can withdraw at any time without affecting their future medical care.
  • Patients must have suitable veins for blood sampling required by the study.
  • Patients must have specific laboratory test results within normal ranges, including:
    • Absolute neutrophil count of at least 1,500 cells per microliter, unless the bone marrow is affected by Hodgkin Lymphoma.
    • Platelet count of at least 75,000 cells per microliter, unless the bone marrow is affected by Hodgkin Lymphoma.
    • Total bilirubin less than 1.5 times the upper limit of normal, unless the increase is due to a condition called Gilbert syndrome.
    • ALT or AST levels less than 3 times the upper limit of normal, or up to 5 times if the increase is due to Hodgkin Lymphoma in the liver. ALT and AST are enzymes that help assess liver function.
    • Serum creatinine less than 2.0 mg/dL, or a creatinine clearance greater than 40 mL/minute. These tests help assess kidney function.
    • Hemoglobin level of at least 8 g/dL, which is a measure of the oxygen-carrying protein in the blood.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than advanced classical Hodgkin lymphoma cannot participate. Hodgkin lymphoma is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
  • Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it is important for participants to be within the required age group.
  • Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results are not eligible.
  • Individuals who are pregnant or breastfeeding are not allowed to participate in the study.
  • Patients who have received certain treatments or medications that might affect the study outcomes are excluded.
  • People with certain medical conditions that could make participation unsafe or affect the study results are not eligible.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care, are not allowed to participate.
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Investigated drugs

  • Brentuximab vedotin (ADCETRIS)

    is a medication used in this trial to treat advanced classical Hodgkin lymphoma. It is combined with other drugs to form a treatment regimen known as A+AVD. Brentuximab vedotin works by targeting and destroying cancer cells, helping to prevent the progression of the disease.

  • Doxorubicin (Adriamycin)

    is a chemotherapy drug included in both treatment regimens, A+AVD and ABVD, in this trial. It works by interfering with the growth and spread of cancer cells in the body.

  • Vinblastine

    is another chemotherapy medication used in both A+AVD and ABVD regimens. It helps to stop cancer cells from dividing and growing, which can slow or stop the progression of the disease.

  • Dacarbazine

    is a chemotherapy drug that is part of both the A+AVD and ABVD treatment regimens. It works by damaging the DNA of cancer cells, which can lead to their death and help control the spread of Hodgkin lymphoma.

  • Bleomycin

    is a medication used in the ABVD regimen. It is a type of chemotherapy that helps to kill cancer cells and reduce the size of tumors. It is not used in the A+AVD regimen.

What is already known about the treatment

Brentuximab Vedotin (ADCETRIS®) – This medication is administered intravenously and is currently used in the treatment of advanced classical Hodgkin lymphoma. It is well-documented in medical literature as a targeted therapy. The main therapeutic indication is for patients with this type of lymphoma. Brentuximab vedotin works by delivering a cytotoxic agent directly to cancer cells, targeting a protein called CD30 on the surface of these cells, which helps to destroy them. It is classified as an antibody-drug conjugate.

Investigated diseases

Advanced Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body's ability to fight infections. The progression of the disease can vary, with some individuals experiencing slow growth and others more rapid advancement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506419-16-00Protocol codeC25003Estimated enrolment1 334 patientsSponsorTakeda Development Center Americas Inc.

sourced from the EU Clinical Trials Register and site verification

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