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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

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 De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Pratia S.A. Skorzewo Poland
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Universita Degli Studi Di Brescia Brescia Italy
Iocdtxip Cpgzqw Drgbbvrpwjptnavpp L'hospitalet De Llobregat Spain
Hscaewbc Vzum dclxhsyr Barcelona Spain

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
13.07.2021
Italy Italy
Not recruiting
13.07.2021
Poland Poland
Not recruiting
13.07.2021
Spain Spain
Not recruiting
13.07.2021

Trial locations

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.

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 ID:
2023-503387-16-00
Protocol code:
SGN35-027
Trial Phase:
Therapeutic exploratory (Phase II)

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