Study Comparing Brentuximab Vedotin with Drug Combination for Treating Advanced Classical Hodgkin Lymphoma in Patients

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What is this study about?

This clinical trial is focused on studying a type of cancer called Advanced Classical Hodgkin Lymphoma. The trial is comparing two different treatment combinations to see which one is more effective as a first treatment option for this disease. The first treatment combination includes a medication called brentuximab vedotin (also known by its code name SGN-35) along with three other drugs: doxorubicin, vinblastine, and dacarbazine. This combination is referred to as A+AVD. The second treatment combination includes the same three drugs—doxorubicin, vinblastine, and dacarbazine—plus another drug called bleomycin. This combination is known as ABVD.

The purpose of the study is to compare how well patients do with each treatment combination in terms of how long they live without the disease getting worse. The study is designed to be open-label, meaning both the doctors and the patients know which treatment is being given. Participants in the study will receive their assigned treatment through an intravenous (IV) method, which means the medication is given directly into a vein. The study will last for a period of up to 24 months, during which time the patients will be monitored regularly to assess their response to the treatment.

Throughout the study, the effectiveness of the treatments will be evaluated by looking at how long patients live without their disease progressing, as well as their overall survival. The trial aims to provide valuable information that could help improve treatment options for people with advanced classical Hodgkin lymphoma in the future.

1 joining the study

Upon joining the study, the patient is informed about the trial’s purpose and procedures. Consent is obtained to ensure understanding and agreement to participate.

Eligibility is confirmed based on criteria such as age, diagnosis of advanced classical Hodgkin lymphoma, and other health parameters.

2 treatment assignment

The patient is randomly assigned to one of two treatment groups: A+AVD or ABVD.

The A+AVD group receives brentuximab vedotin (ADCETRIS®) along with doxorubicin, vinblastine, and dacarbazine.

The ABVD group receives doxorubicin, bleomycin, vinblastine, and dacarbazine.

3 treatment administration

All medications are administered through intravenous use.

The specific dosages and frequency of administration are determined by the study protocol and the patient’s health status.

4 monitoring and assessments

Regular monitoring is conducted to assess the patient’s response to treatment and to manage any side effects.

Assessments include physical examinations, blood tests, and imaging studies to evaluate the progression of the disease.

5 completion of treatment

The treatment phase continues as per the study’s schedule until the completion of the prescribed cycles.

Upon completion, the patient’s health and response to treatment are thoroughly evaluated.

6 follow-up

After the treatment phase, follow-up visits are scheduled to monitor the patient’s long-term health and any potential late effects of the treatment.

These visits help in assessing the overall survival and progression-free survival of the patient.

Who Can Join the Study?

Male or female patients who are 18 years or older.
Patients who have not received treatment for their condition and have advanced Hodgkin Lymphoma, which is a type of cancer affecting the lymphatic system, at Stage III or IV.
The diagnosis of classical Hodgkin Lymphoma must be confirmed through a tissue examination, following the guidelines of the World Health Organization.
Patients must have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities, with lower numbers indicating better functioning.
Patients must have measurable disease, meaning the cancer can be measured in size using imaging techniques like a CT scan, according to specific criteria for assessing lymphoma.
Female patients must either be postmenopausal, surgically sterile, or agree to use two effective methods of birth control or practice true abstinence during the study and for six months after the last dose of the study drug. Male patients must agree to use effective barrier contraception or practice true abstinence during the study and for six months after the last dose of the study drug.
Patients must provide voluntary written consent to participate in the study, understanding they can withdraw at any time without affecting their future medical care.
Patients must have suitable veins for blood sampling required by the study.
Patients must have specific laboratory test results within normal ranges, including:
- Absolute neutrophil count of at least 1,500 cells per microliter, unless the bone marrow is affected by Hodgkin Lymphoma.
- Platelet count of at least 75,000 cells per microliter, unless the bone marrow is affected by Hodgkin Lymphoma.
- Total bilirubin less than 1.5 times the upper limit of normal, unless the increase is due to a condition called Gilbert syndrome.
- ALT or AST levels less than 3 times the upper limit of normal, or up to 5 times if the increase is due to Hodgkin Lymphoma in the liver. ALT and AST are enzymes that help assess liver function.
- Serum creatinine less than 2.0 mg/dL, or a creatinine clearance greater than 40 mL/minute. These tests help assess kidney function.
- Hemoglobin level of at least 8 g/dL, which is a measure of the oxygen-carrying protein in the blood.

Who Cannot Join the Study?

Patients who have a different type of cancer other than advanced classical Hodgkin lymphoma cannot participate. Hodgkin lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s immune system.
Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it is important for participants to be within the required age group.
Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results are not eligible.
Individuals who are pregnant or breastfeeding are not allowed to participate in the study.
Patients who have received certain treatments or medications that might affect the study outcomes are excluded.
People with certain medical conditions that could make participation unsafe or affect the study results are not eligible.
Individuals who are part of a vulnerable population, which means they might need special protection or care, are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario De Navarra	Pamplona	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy	Argenteuil	France
Orszagos Onkologiai Intezet	Budapest	Hungary
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Del Mar	Barcelona	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
University Of Debrecen	Debrecen	Hungary
Hospital Clinic De Barcelona	Barcelona	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Pratia S.A.	Skorzewo	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
ARNAS G. Brotzu	Cagliari	Italy
Rigshospitalet	Copenhagen	Denmark
University Of Pecs	Pecs	Hungary
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
Hospital Costa del Sol	Marbella	Spain
Region Sjaelland	Holbæk	Denmark
IRCCS CROB	Rionero In Vulture	Italy
Ihohyd Iqcegkgs Faayppxjhsufy Osnrgvcqtgj	Rome	Italy
Comiek Hdllpibhids Eh Ubknrdevusdhl Du Leqskus	Limoges	France
Akypcj Ujdigrehsm Hyjxymim	Aarhus	Denmark
Gkwprikmluarxtfut Vqnhwugyn Pstr Ancpry Enjeuiet Ohdscp Kfbvbp	Gyor	Hungary
Aeyvbsg Otmrlpwigws Nctkxyppp Sq Areckfx E Becwhw E C Afqpkv Ajdzagunrcf	Alexandria	Italy
Ncokjdxi Iaryemzm Ojubaytbh Ihm Mwduz Snnwatxshqdpihwgpvfhvftwmane Idbdtmae Bymbnvlo	Cracow	Poland
Avobzmo Unvao Saoftaiqf Lcgstw Dq Blccxtq	Bologna	Italy
Uzmipyddbpkdls Ctprkun Kypyiihjy	Gdansk	Poland
Hoawjxyd Dm Lx Sannm Cvyc I Sszt Pvo	Barcelona	Spain
Iqyzfexq Cyrsoc Dczbfqfrqeuugomxi	L'hospitalet De Llobregat	Spain
Wayyyypgvqh Wuplvtnyuhlyxqpzyzos Cnbcgec Oahlyjdbl I Tdtxhddwmxeim Im Mpdzsmkhxox W Lhhml	Lodz	Poland
Svlnujkqgkw Pzvvhbbej Suarylw Kpanhycxq Iastghhzirc Mgocbywqyhy Ssm W Ksfddxkvbx	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	17.10.2012
Czechia	Not recruiting	17.10.2012
Denmark	Not recruiting	17.10.2012
France	Not recruiting	17.10.2012
Hungary	Not recruiting	17.10.2012
Italy	Not recruiting	17.10.2012
Norway	Not recruiting	17.10.2012
Poland	Not recruiting	17.10.2012
Spain	Not recruiting	17.10.2012

Trial locations

Investigated drugs:

Brentuximab vedotin (ADCETRIS) is a medication used in this trial to treat advanced classical Hodgkin lymphoma. It is combined with other drugs to form a treatment regimen known as A+AVD. Brentuximab vedotin works by targeting and destroying cancer cells, helping to prevent the progression of the disease.

Doxorubicin (Adriamycin) is a chemotherapy drug included in both treatment regimens, A+AVD and ABVD, in this trial. It works by interfering with the growth and spread of cancer cells in the body.

Vinblastine is another chemotherapy medication used in both A+AVD and ABVD regimens. It helps to stop cancer cells from dividing and growing, which can slow or stop the progression of the disease.

Dacarbazine is a chemotherapy drug that is part of both the A+AVD and ABVD treatment regimens. It works by damaging the DNA of cancer cells, which can lead to their death and help control the spread of Hodgkin lymphoma.

Bleomycin is a medication used in the ABVD regimen. It is a type of chemotherapy that helps to kill cancer cells and reduce the size of tumors. It is not used in the A+AVD regimen.

Advanced Classical Hodgkin Lymphoma – This 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, 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, and bone marrow. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body’s ability to fight infections. The progression of the disease can vary, with some individuals experiencing slow growth and others more rapid advancement.

Trial ID:

2023-506419-16-00

Protocol code:

C25003

NCT ID:

NCT01712490

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Brentuximab Vedotin with Drug Combination for Treating Advanced Classical Hodgkin Lymphoma in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?