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Title: Comparing Brentuximab Vedotin plus ESHAP versus ESHAP alone in treating patients with relapsed or refractory classical Hodgkin's Lymphoma

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 clinical trial focuses on patients with Classical Hodgkin's Lymphoma that has returned or is not responding to previous treatment. The study tests two different treatment approaches using Brentuximab Vedotin (also known as ADCETRIS) in combination with another treatment called ESHAP. The purpose is to determine which treatment approach is more effective in achieving complete remission of the disease.

The treatment involves receiving either Brentuximab Vedotin combined with ESHAP or ESHAP alone for three treatment cycles. Brentuximab Vedotin is given through an intravenous infusion, which means it is delivered directly into a vein. The maximum daily dose is 180 milligrams, and the treatment period can last up to 58 weeks. After the initial treatment cycles, patients who show complete remission will receive additional Brentuximab Vedotin treatment instead of undergoing a stem cell transplant.

During the study, doctors will use special imaging scans called PET-CT to check how well the treatment is working. The study will monitor patients for up to three years to track their progress and any long-term effects of the treatment. This includes checking for signs of disease progression, overall health status, and quality of life.

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 treatment phase

    You will be randomly assigned to receive one of two treatment options: either ESHAP alone or ESHAP combined with brentuximab vedotin (BV)

    The treatment will be administered through intravenous infusion

    You will receive 3 treatment cycles

  2. Step 2

    Response evaluation

    After completing 3 cycles of treatment, your response will be evaluated using a PET-CT scan

    The scan will determine if you have achieved a complete metabolic response to the treatment

    The response is measured using a scoring system called Deauville scores

  3. Step 3

    Consolidation treatment

    If you achieve a complete metabolic response, you will receive brentuximab vedotin consolidation therapy

    This consolidation treatment replaces the traditional stem cell transplantation procedure

  4. Step 4

    Follow-up period

    Your health status will be monitored for at least 2 years to track progression-free survival and overall survival

    Regular evaluations will assess your response duration and time until any disease progression

    Your quality of life will be evaluated throughout the study period

    Health monitoring will continue for 3 years to check for any long-term effects, including fertility and secondary health conditions

Who can join the trial?

12 criteria

  • Age between 18 and 65 years old, both men and women can participate
  • Must provide written informed consent to participate in the study procedures
  • For women who can become pregnant: must use 2 effective birth control methods during the study and for 6 months after the last dose, or completely avoid heterosexual intercourse
  • For men: must use effective barrier contraception during the study and for 6 months after the last dose, or completely avoid heterosexual intercourse
  • Must have an ECOG performance status of 0 to 2 (ability to perform daily activities and work)
  • Must have measurable disease with lymph nodes or masses of at least 1.5 cm
  • No nerve problems (neuropathy) of grade 2 or higher
  • Must meet the following laboratory test requirements:
    • Adequate white blood cell count (neutrophils ≥1,500/µL)
    • Adequate platelet count (≥75,000/µL)
    • Normal or near-normal liver function tests
    • Adequate kidney function
    • Hemoglobin level of at least 8g/dL (blood count)

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with brentuximab vedotin (a type of targeted cancer therapy)
  • Known allergy or sensitivity to study medications
  • Pregnant or breastfeeding women
  • Active, uncontrolled infections
  • Significant heart problems, including:
    • Heart failure
    • Uncontrolled high blood pressure
    • Recent heart attack
    • Severe liver problems (liver function tests more than 3 times the normal limit)
    • Severe kidney problems (creatinine clearance less than 30 mL/min)
    • Other active cancers (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
    • Participation in other clinical trials within 30 days before starting this study
    • Mental conditions that could interfere with following study procedures
    • HIV, active hepatitis B, or hepatitis C infection
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Investigated drugs

Brentuximab vedotin is a targeted medication used to treat Hodgkin's lymphoma. It works by attaching to a specific protein found on cancer cells and delivering a substance that helps destroy these cells. It is often used when the cancer has returned after previous treatments or hasn't responded well to other therapies. ESHAP is a combination chemotherapy regimen that includes four different medications (etoposide, methylprednisolone, cytarabine, and cisplatin). This combination is commonly used as a salvage therapy for patients with lymphoma that has returned or hasn't responded to initial treatment. Each medication in this combination works in a different way to kill cancer cells or stop them from growing. The trial compares the effectiveness of using ESHAP alone versus combining it with Brentuximab vedotin in treating patients whose Hodgkin's lymphoma has either returned or didn't respond to previous treatments.

What is already known about the treatment

  • Brentuximab Vedotin

    An antibody-drug conjugate administered intravenously that specifically targets CD30-positive lymphoma cells, primarily used in treating relapsed or refractory classical Hodgkin's Lymphoma. The medication works by delivering a potent chemotherapy agent directly to cancer cells, combining an anti-CD30 monoclonal antibody with the cell-killing agent monomethyl auristatin E (MMAE). As a targeted therapy in the class of antibody-drug conjugates, it has shown significant efficacy in clinical trials when used alone or in combination with traditional chemotherapy regimens like ESHAP, offering a valuable treatment option for patients whose disease has returned after previous treatments.

  • ESHAP

    A combination chemotherapy regimen consisting of etoposide, methylprednisolone (solumedrol), high-dose cytarabine (ara-C), and cisplatin, administered intravenously in cycles for treating relapsed or refractory Hodgkin's Lymphoma. This salvage therapy protocol works through multiple mechanisms to kill cancer cells, with each component targeting different aspects of cell division and growth. The regimen is well-established in medical literature as a standard salvage treatment option, typically used before stem cell transplantation in patients whose lymphoma has returned or become resistant to initial therapy.

Investigated diseases

Hodgkin Lymphoma - A type of blood cancer that starts in the lymphatic system, specifically affecting lymphocytes (a type of white blood cell). The disease typically begins in the lymph nodes, causing them to enlarge, and can spread through the lymphatic vessels to other lymph node groups. As it progresses, the abnormal lymphocytes may spread to other organs beyond the lymphatic system. The disease commonly appears first in the lymph nodes in the upper body, such as those in the neck, chest, or underarms. Hodgkin Lymphoma is characterized by the presence of specific abnormal cells called Reed-Sternberg cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516149-38-00Estimated enrolment151 patientsSponsorFundacion Geltamo

sourced from the EU Clinical Trials Register and site verification

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