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Study on Reducing Side Effects in Advanced Hodgkin Lymphoma Using Brentuximab Vedotin and Drug Combination for Newly Diagnosed 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 the treatment of Advanced Stage Hodgkin Lymphoma, a type of cancer that affects the lymphatic system, which is part of the immune system. The study compares two treatment regimens: one called escalated BEACOPP and another called BrECADD. The BrECADD regimen includes a combination of medications such as Brentuximab Vedotin (also known as SGN-35), Doxorubicin Hydrochloride, Dexamethasone, Cyclophosphamide Monohydrate, Etoposide, and Prednisone. The escalated BEACOPP regimen includes medications like Bleomycin Sulfate, Etoposide Phosphate, Doxorubicin Hydrochloride, Cyclophosphamide Monohydrate, Vincristine Sulfate, Procarbazine Hydrochloride, and Prednisone.

The purpose of the study is to determine if the BrECADD treatment is less toxic than the escalated BEACOPP treatment while maintaining similar effectiveness. Participants will receive either 4 to 6 cycles of the escalated BEACOPP or 4 to 6 cycles of BrECADD, followed by radiotherapy if there are any remaining cancerous areas detected by a PET scan, which is a type of imaging test. The study aims to assess the safety and effectiveness of these treatments in terms of reducing treatment-related side effects and preventing the cancer from worsening.

Throughout the study, participants will be monitored for various outcomes, including how well the cancer responds to treatment, overall survival rates, and any side effects experienced. The study will also look at the quality of life of participants and the occurrence of any new cancers. The trial is designed to provide valuable information on optimizing treatment for patients with advanced Hodgkin Lymphoma, aiming to improve patient outcomes and reduce the burden of treatment side effects.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of classical Hodgkin lymphoma and ensuring no prior treatment has been received.

    Eligibility is determined based on the stage of the disease, which should be stage IIB with large mediastinal mass and/or extranodal lesions, stage III, or stage IV. Age criteria are also considered, with participants being between 18 to 75 years old.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: the escalated BEACOPP group or the BrECADD group.

    This randomization ensures that each participant has an equal chance of receiving either treatment, which helps in comparing the effectiveness and safety of the two regimens.

  3. Step 3

    Treatment phase

    Participants receive 4 to 6 cycles of their assigned treatment. Each cycle involves a combination of medications administered over a specific period.

    For the escalated BEACOPP group, medications include doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, procarbazine hydrochloride, prednisone, dacarbazine, and cyclophosphamide monohydrate. These are given through intravenous infusion or oral use.

    For the BrECADD group, medications include brentuximab vedotin, doxorubicin hydrochloride, dexamethasone, etoposide phosphate, cyclophosphamide monohydrate, and dacarbazine. These are also administered through intravenous infusion or oral use.

  4. Step 4

    Radiotherapy

    After completing the chemotherapy cycles, participants with PET-positive residual lesions undergo radiotherapy.

    This step aims to target any remaining cancer cells and reduce the risk of disease progression.

  5. Step 5

    Follow-up

    Participants enter a follow-up phase where their health and response to treatment are monitored.

    The primary focus is on assessing treatment-related side effects, progression-free survival, and overall survival. Additional evaluations include tumor response, quality of life, and any adverse events experienced during the trial.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of **classical Hodgkin lymphoma**. This means that a doctor has checked the type of lymphoma through a biopsy or similar test.
  • The patient should be newly diagnosed, meaning they have not received any previous treatment for Hodgkin lymphoma.
  • The patient must be in **Stage IIB** with a large mass in the chest area or cancer that has spread outside the lymph nodes, or in **Stage III** or **Stage IV**. These stages indicate how far the cancer has spread in the body.
  • For the main part of the study, the patient should be between 18 and 60 years old.
  • For a specific group of older patients, the age range is between 61 and 75 years old.
  • Both male and female patients are eligible to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Hodgkin Lymphoma in an advanced stage.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or comply with the study requirements.
  • Patients who have other serious health conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have an active infection that requires treatment.
  • Patients who have received certain treatments for cancer recently.
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Investigated drugs

  • Escalated BEACOPP

    is a combination chemotherapy regimen used to treat advanced stage Hodgkin lymphoma. It includes several drugs that work together to kill cancer cells and stop them from growing. This treatment is known for its effectiveness but can also cause significant side effects.

  • BrECADD

    is another combination chemotherapy regimen being studied for the treatment of advanced stage Hodgkin lymphoma. It is designed to be less toxic than escalated BEACOPP while maintaining similar effectiveness. The goal is to reduce the side effects experienced by patients during treatment.

What is already known about the treatment

  • Escalated BEACOPP

    This medication regimen is administered intravenously and is used in the treatment of advanced-stage Hodgkin lymphoma. It is well-documented in medical literature as a standard chemotherapy protocol. The main therapeutic indication is to treat Hodgkin lymphoma by targeting rapidly dividing cancer cells. At the molecular level, it works by interfering with DNA replication and cell division, leading to cancer cell death. It is classified as a combination chemotherapy regimen.

  • BrECADD

    This medication regimen is also administered intravenously and is being studied for its potential to treat advanced-stage Hodgkin lymphoma with reduced toxicity compared to escalated BEACOPP. It is currently under clinical investigation to confirm its efficacy and safety. The main therapeutic indication is to treat Hodgkin lymphoma by targeting cancer cells while aiming to minimize side effects. Its mechanism of action involves disrupting cancer cell growth and division. It is classified as a combination chemotherapy regimen.

Investigated diseases

Hodgkin Lymphoma – Hodgkin Lymphoma 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. Advanced stages of Hodgkin Lymphoma may involve more widespread lymph node involvement and additional systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518022-33-00Protocol codeUni-Koeln-1762Estimated enrolment1 585 patientsSponsorUniversity Of Cologne

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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).