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Study of Brentuximab Vedotin, Doxorubicin Hydrochloride, and Dacarbazine for Patients with Untreated Classical Hodgkin Lymphoma

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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 disease called Classical Hodgkin Lymphoma, which is a type of cancer that affects the lymphatic system, a part of the immune system. The trial will explore the effectiveness of a treatment involving a medication called Brentuximab Vedotin. This medication is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and kill cancer cells. The study will also involve other medications, including Dacarbazine, Doxorubicin Hydrochloride, and Nivolumab. These medications are used in combination to enhance the treatment's effectiveness.

The purpose of the study is to assess how well the treatment works in achieving a complete response, which means the disappearance of all signs of cancer in the body, in patients who have not been treated before. Participants in the study will receive the treatment through intravenous infusion, which means the medication is given directly into a vein. The study will be conducted over several parts, and each part will have a specific focus on different aspects of the treatment and its effects on the disease.

Throughout the study, participants will be monitored for any side effects or changes in their condition. The study aims to gather information on the safety and effectiveness of the treatment, as well as to understand how the disease responds to the combination of medications. The trial is expected to continue until 2027, providing valuable insights into the treatment of Classical Hodgkin Lymphoma.

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

    Joining the study

    Upon joining the study, participation is confirmed for individuals with classical Hodgkin lymphoma (cHL) who have not received prior treatment. Eligibility includes having a specific stage of the disease and meeting certain health criteria.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the diagnosis of classical Hodgkin lymphoma. This involves imaging tests such as PET/CT or CT scans to measure the disease.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of medications through intravenous infusion. The medications used include dacarbazine, doxorubicin hydrochloride, brentuximab vedotin, and nivolumab.

    Each medication is provided in a specific form and dosage: Dacarbazine Lipomed 500 mg, DOXORUBICINE ACCORD 2 mg/ml, ADCETRIS 50 mg, and OPDIVO 10 mg/mL. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes evaluating the complete response rate at the end of treatment (EOT) and monitoring for any adverse effects or laboratory abnormalities.

  5. Step 5

    Completion of the trial

    The trial is estimated to conclude by November 15, 2027. Upon completion, the overall response rate and other outcomes such as duration of response and progression-free survival are evaluated.

Who can join the trial?

8 criteria

  • The patient must have **Classical Hodgkin Lymphoma (cHL)**, which is a type of cancer that affects the lymphatic system.
  • The patient should not have received any treatment for cHL before joining the study.
  • The patient must have **Ann Arbor Stage I or II cHL**, which means the cancer is in its early stages and has not spread extensively.
  • The patient should not have **bulky mediastinal disease**, which refers to a large mass in the chest area.
  • The diagnosis of cHL must be confirmed through a **histological examination**, which involves studying tissue samples under a microscope.
  • The patient must have a **bidimensional measurable disease**, meaning the cancer can be measured in two dimensions using imaging tests like PET/CT or CT scans.
  • The patient must be at least 12 years old if they are in the United States. In other regions, the patient must be at least 18 years old.
  • The patient must have an **ECOG performance status of 2 or less**, which is a scale used to assess how well a patient can perform daily activities. A score of 2 or less indicates the patient is able to carry out most activities.

Who cannot join the trial?

3 criteria

  • Patients who have already received treatment for **Classical Hodgkin Lymphoma** cannot participate. This means if you have been treated for this type of cancer before, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The study is only for certain age groups.
  • Patients who are part of a vulnerable population are not eligible. This means if you are in a group that needs special protection, you cannot join the study.
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Investigated drugs

Brentuximab Vedotin is a medication used in this clinical trial for treating classical Hodgkin lymphoma. It works by targeting a specific protein found on the surface of cancer cells, delivering a substance that can help kill these cells. This medication is being studied to see how effective it is in achieving a complete response in patients who have not been treated for this type of lymphoma before.

What is already known about the treatment

Brentuximab Vedotin – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness in treating classical Hodgkin Lymphoma. The main therapeutic use of Brentuximab Vedotin is to target and destroy cancer cells in this type of lymphoma. At the molecular level, it works by binding to a protein called CD30 on the surface of cancer cells, delivering a toxic agent that disrupts the cell's ability to divide and grow. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug to specifically target cancer cells.

Investigated diseases

Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body's ability to fight infections. The exact cause of Classical Hodgkin Lymphoma is not well understood, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503387-16-00Protocol codeSGN35-027Estimated enrolment255 patientsSponsorSeagen Inc.

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