Study on Early Response to Brentuximab Vedotin and Drug Combination for Advanced Hodgkin Lymphoma Patients

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What is this study about?

This clinical trial is focused on studying advanced stage Hodgkin lymphoma, a type of cancer that affects the lymphatic system, which is part of the body’s immune system. The study will use a combination of medications to treat this disease, including Brentuximab Vedotin, Doxorubicin, Etoposide, Cyclophosphamide, Vinblastine, Dacarbazine, and Dexamethasone. These medications are often used in chemotherapy, which is a treatment that uses drugs to stop the growth of cancer cells.

The purpose of the study is to see if adjusting the treatment based on early results from a special type of scan called FDG-PET/CT can improve the effectiveness of the treatment while reducing side effects. Participants will receive the treatment through an infusion, which means the medication is given directly into the bloodstream. The study will follow a specific plan where the treatment is adjusted based on the early scan results. This approach aims to find the best way to treat the disease with the least amount of side effects.

Throughout the study, the main focus will be on how long patients can live without the disease getting worse, which is known as progression-free survival. Other aspects being looked at include the overall survival of patients, the safety and tolerability of the treatment, and the response to the treatment according to specific criteria. The study will also involve taking additional blood samples and using tissue samples to help understand the treatment’s effects better.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A FDG-PET/CT scan is performed to determine the stage of Hodgkin lymphoma. This scan uses a special dye to highlight areas of the body, helping to assess the disease’s extent.

2 treatment cycle 1

The first treatment cycle begins with the administration of the BrAVD regimen. This includes the following medications:

Brentuximab vedotin is given as an infusion. The dosage and frequency are determined by the study protocol.

Doxorubicin, etoposide, cyclophosphamide, and vinblastine are also administered as infusions. The specific dosages and schedules are outlined in the study protocol.

The cycle duration is specified in the study protocol, and the treatment is monitored closely for any side effects.

3 early response assessment

After the first cycle, another FDG-PET/CT scan is conducted to assess the response to the treatment.

The results of this scan help determine the next steps in the treatment plan.

4 treatment cycle 2 and beyond

Based on the early response assessment, the treatment may be adjusted. The BrECADD regimen may be introduced, which includes the following medications:

Brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone are administered as infusions. The specific dosages and schedules are outlined in the study protocol.

The treatment cycles continue as per the study protocol, with regular monitoring and assessments.

5 ongoing assessments

Throughout the study, regular assessments are conducted to monitor the disease’s progression and the treatment’s effectiveness.

These assessments include physical examinations, blood tests, and imaging studies as specified in the study protocol.

6 end of treatment evaluation

At the end of the treatment period, a final evaluation is conducted to assess the overall response to the therapy.

This includes a comprehensive review of all imaging studies and clinical assessments performed during the trial.

7 follow-up

After completing the treatment, follow-up visits are scheduled to monitor long-term outcomes and any potential late side effects.

These visits include regular check-ups and may involve additional imaging studies as needed.

Who Can Join the Study?

The patient must have advanced stage Hodgkin Lymphoma, which is a type of cancer that affects the lymphatic system.
The patient should not have received any previous treatment for Hodgkin Lymphoma, and the diagnosis must be confirmed by a biopsy.
The patient must not have any medical, psychological, family, social, or geographical issues that could prevent them from following the study plan and schedule.
The patient must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
The patient must have their disease staged using a PET scan with a CT scan that uses a contrast dye. The disease should be at specific stages: Stage IIB with a large mass in the chest or spread to other areas, Stage III, or Stage IV.
The patient must agree to participate in additional research, which includes giving extra blood samples and having enough tissue samples available for study.
The patient must be between the ages of 18 and 60.
The patient must have a WHO performance status of 0-2, which is a measure of their ability to perform daily activities.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
Women who can become pregnant must have a negative pregnancy test within 72 hours before starting the study treatment.
Patients who can have children must use two methods of birth control from the time they agree to participate in the study, throughout the study, and for 6 months after the last treatment.
Women who are breastfeeding must stop nursing before starting the study treatment and continue to refrain from breastfeeding until 6 months after the last treatment.

Who Cannot Join the Study?

Patients who do not have advanced stage Hodgkin Lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
Frisius	Heerenveen	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Narodny Onkologicky Ustav	Bratislava	Slovakia
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Gasthuiszusters Antwerpen	Antwerp	Belgium
Deventer Ziekenhuis	Deventer	The Netherlands
Medical Center Haaglanden	Leidschendam	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Uxgcampaaeww Mcykocw Cjacmmq Gzrfbegvo	Groningen	The Netherlands
Iwundbxa Cocyoh Dlnnuhlvnebhuyjqv	L'hospitalet De Llobregat	Spain
Abftznyiz Ujo	Amsterdam	The Netherlands
Efhgihg Uyfbgdtshmvc Mkmcqie Chxnpcr Rinweyxew (yeblnch Mpe	Rotterdam	The Netherlands
Nktcgqwu Iwakguyd Oyatqmiuy Ihi Mnslu Saiwcnrsixjdrgacyxtgifhsjejm Ihscrkgu Bovylgpg	Cracow	Poland
Ugxbyhxngt Oi Azsiohl	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.02.2019
Denmark	Not recruiting	01.02.2019
Poland	Not recruiting	01.02.2019
Portugal	Not recruiting	01.02.2019
Slovakia	Not recruiting	01.02.2019
Spain	Not recruiting	01.02.2019
The Netherlands	Not recruiting	01.02.2019

Trial locations

Investigated drugs:

Brentuximab Vedotin is a type of medication used in the treatment of Hodgkin lymphoma. It works by targeting a specific protein found on the surface of cancer cells. Once it attaches to the cancer cell, it releases a substance that helps to kill the cell. This medication is often used when other treatments have not been successful or as part of a combination therapy to improve outcomes.

BrAVD is a combination therapy that includes Brentuximab Vedotin along with other chemotherapy drugs. This combination is designed to work together to attack cancer cells more effectively. Each component of the therapy has a specific role in stopping the growth and spread of cancer cells, making it a powerful option for treating advanced Hodgkin lymphoma.

BrECADD is another combination therapy that includes Brentuximab Vedotin and additional chemotherapy drugs. This regimen is tailored to target cancer cells in multiple ways, aiming to improve the chances of stopping the disease from progressing. By using a mix of medications, this therapy seeks to enhance the overall effectiveness of the treatment for patients with advanced Hodgkin lymphoma.

Investigated diseases:

Hodgkin's disease

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 typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, bone marrow, and lungs. 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 while others may progress more rapidly. The disease is often categorized into stages, with advanced stages indicating more widespread involvement.

Trial ID:

2023-508478-27-00

Protocol code:

1537-LYMG

NCT ID:

NCT03517137

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Early Response to Brentuximab Vedotin and Drug Combination for Advanced Hodgkin Lymphoma Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?