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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Del Mar Barcelona Spain
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario Central De Asturias Oviedo Spain
KBC Zagreb Zagreb Croatia
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Unviersitario Miguel Servet Zaragoza Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Son Llatzer Palma Spain
Hospital Costa del Sol Marbella Spain
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Ilvrpvpi Cbvtha Dwjbznzztkpvqlkpb L'hospitalet De Llobregat Spain
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Haepkdyp Ulvvdmpwwgyov Dpfwlfjn Donostia / San Sebastian Spain
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Uxzcuanpzx Gtsuajd Hzitzits Aodlbda Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
05.06.2020
Croatia Croatia
Not recruiting
05.06.2020
Greece Greece
Not recruiting
05.06.2020
Spain Spain
Not recruiting
05.06.2020

Trial locations

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.

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 ID:
2024-516149-38-00
NCT ID:
NCT04378647
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

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  • Study of pembrolizumab with drug combination for first-line treatment in patients with advanced-stage classic Hodgkin lymphoma

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