Study of Brentuximab Vedotin, Adriamycin, Vinblastine, and Dacarbazine for Children with Advanced Stage Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Hodgkin lymphoma, which affects the lymphatic system, a part of the immune system. The study is specifically for children who have been newly diagnosed with advanced stages of this disease. The treatment being tested includes a combination of medications: brentuximab vedotin (also known by its code name SGN-35), Adriamycin, vinblastine, and dacarbazine. Brentuximab vedotin is a medication that targets cancer cells, and it is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to find out how safe and tolerable the treatment is and to determine the best dose of brentuximab vedotin when used with the other medications. The study will also look at how well the treatment works in reducing the cancer. Participants will receive the treatment over several cycles, and their health will be monitored throughout the study to see how they respond to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study is divided into two phases. In the first phase, the focus is on finding the right dose and checking for any side effects. In the second phase, the study will evaluate how effective the treatment is in achieving a complete response, which means the cancer is no longer detectable. The study will also assess how many participants can complete all six cycles of the treatment. The overall goal is to improve the treatment options for children with advanced Hodgkin lymphoma.

1 joining the study

Upon joining the study, you will be introduced to the clinical trial team. They will explain the study’s purpose and procedures in detail. You will have the opportunity to ask any questions you may have about the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility for the study. This may include a physical examination, blood tests, and imaging studies to evaluate your condition.

3 treatment phase 1

You will begin the treatment with a combination of medications, including brentuximab vedotin, Adriamycin, vinblastine, and dacarbazine. These medications will be administered through an intravenous infusion, which means they will be given directly into your bloodstream through a vein.

The treatment will be given in cycles. Each cycle lasts for a specific period, followed by a rest period to allow your body to recover. The exact dosage and frequency will be determined by the clinical trial team based on your individual needs.

4 monitoring and assessments

Throughout the treatment, regular monitoring and assessments will be conducted to evaluate your response to the therapy and to check for any side effects. This may include physical exams, blood tests, and imaging studies.

The clinical trial team will closely monitor your health and adjust the treatment plan as necessary to ensure your safety and well-being.

5 treatment phase 2

If you continue to meet the criteria for the study, you will proceed to the second phase of treatment. This phase will involve additional cycles of the same combination of medications.

The goal of this phase is to further evaluate the effectiveness of the treatment and to monitor for any long-term effects.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted to determine the overall response to the therapy. This will include a comprehensive evaluation of your health and any changes in your condition.

The clinical trial team will discuss the results with you and provide guidance on any further steps or follow-up care that may be needed.

7 follow-up

After completing the treatment, you will enter a follow-up phase. During this time, periodic assessments will be conducted to monitor your health and to gather additional information about the long-term effects of the treatment.

The follow-up phase is an important part of the study, as it helps to ensure your continued well-being and to provide valuable data for future research.

Who Can Join the Study?

Patients must be male or female and aged between 5 to under 18 years.
Patients must have been newly diagnosed with a type of cancer called classical CD30+ advanced stage Hodgkin lymphoma, specifically Stage III or Stage IV.
Patients must not have received any treatment for their Hodgkin lymphoma before (they are treatment naïve).
Patients must have a certain level of physical ability, measured by a score called the Karnofsky Performance Status or Lansky Play-Performance, which should be 50 or higher. This score helps doctors understand how well the patient can perform daily activities.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with Hodgkin lymphoma at an advanced stage (Stage III or Stage IV) cannot participate.
Patients with a Lansky Play-Performance or Karnofsky Performance Status below 50 are excluded. These are scales used to measure a patient’s general well-being and ability to carry out daily activities.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to tolerate the study medications or have had severe reactions to similar treatments in the past are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with other serious health conditions that could interfere with the study treatment are excluded.
Patients who are participating in another clinical trial at the same time are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Apjtetv Okopyvpolpf Uvrliiltpslpj Ctqgomqmsqmo Dzwdm Szxtdf E Dyuhv Smjsabl Df Tjsvlo	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	26.09.2017

Trial locations

Investigated drugs:

Brentuximab Vedotin

Brentuximab Vedotin is a type of medication known as an antibody-drug conjugate. It works by targeting specific cancer cells and delivering a drug that can help kill these cells. In this trial, it is being tested to see how safe and effective it is when used with other chemotherapy drugs for treating children with advanced Hodgkin Lymphoma, a type of cancer that affects the lymphatic system.

Adriamycin, also known as Doxorubicin, is a chemotherapy drug that is used to treat various types of cancer. It works by interfering with the growth and spread of cancer cells in the body. In this study, it is part of a combination of drugs used to treat pediatric patients with advanced Hodgkin Lymphoma.

Vinblastine is another chemotherapy medication used in this trial. It helps stop the growth of cancer cells by interfering with their ability to divide and multiply. This drug is part of the multi-drug regimen being tested for its effectiveness in treating children with advanced Hodgkin Lymphoma.

Dacarbazine is a chemotherapy drug that is used to treat certain types of cancer, including Hodgkin Lymphoma. It works by slowing or stopping the growth of cancer cells. In this clinical trial, it is used in combination with other drugs to see how well it works in treating pediatric patients with advanced stages of this disease.

Hodgkin Lymphoma – Hodgkin Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. As it progresses, it may cause symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Hodgkin Lymphoma can vary, with some cases advancing slowly and others more rapidly. The disease is often classified into stages, with Stage III and Stage IV indicating more advanced disease.

Trial ID:

2023-506415-18-00

Protocol code:

C25004

NCT ID:

NCT02979522

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Brentuximab Vedotin, Adriamycin, Vinblastine, and Dacarbazine for Children with Advanced Stage Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?