Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

HD21 for advanced stages - Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD

This research study is looking at the best way to treat advanced Hodgkin lymphoma, a type of cancer that affects the immune system. We are comparing two different combinations of medicines, called chemotherapy regimens. One is called escalated BEACOPP, and the other is BrECADD. Doctors want to see if one treatment is better at controlling the cancer, causes fewer side effects, or improves a patient's quality of life. The study will involve patients with advanced Hodgkin lymphoma and is particularly interested in how these treatments affect older patients. This is a large-scale study, meaning many people will take part, to help doctors understand the most effective and safest approach.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Of Cologne

Enrolment target

1,320

Start

31 Oct 2024

Advanced Stage of Hodgkin Lymphoma

What is this study about?

Imagine your body's immune system as a special army protecting you from illness. Hodgkin lymphoma is a type of cancer that affects some of the soldiers in this army, called lymphocytes. When it's in an 'advanced stage', it means the cancer has spread in your body.

Doctors are always looking for the best ways to fight this cancer. This study is like a careful comparison test between two main treatment plans, known as chemotherapy. Both plans use a mix of powerful medicines designed to kill cancer cells. One plan is called 'escalated BEACOPP', and the other is 'BrECADD'. By comparing them side-by-side, doctors want to find out which one works best, causes the fewest problems, and helps people live longer and feel better.

This research is really important because it will help doctors choose the most effective treatment for future patients with advanced Hodgkin lymphoma. It's a big trial, meaning many people will take part, as this gives the most reliable results. They are also paying special attention to how these treatments affect older patients, as their bodies might react differently to the medicines.

Key takeaways

Compares two chemotherapy treatments for advanced Hodgkin lymphoma.
Aims to find out which treatment is most effective and has fewer side effects.
Includes patients aged 18 and over, with a special focus on older adults.
Participation involves regular appointments, tests, and follow-up.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, people generally need to be 18 years old or older. There is no upper age limit, meaning older adults can also take part. The study needs to include both men and women.

Specifically, you would need to have been diagnosed with advanced-stage Hodgkin lymphoma. This means the cancer has spread beyond its original location, and doctors are looking for the best treatment approach.

There might be other health requirements or conditions that mean you can or cannot join the study. These are put in place to make sure the study is safe for everyone involved and that the results are clear. Your doctor will be able to check these detailed criteria with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with advanced stage Hodgkin lymphoma?
Are you able to attend regular hospital appointments?
Have you discussed your other health conditions with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the escalated BEACOPP or BrECADD chemotherapy treatment, usually for 4 to 6 cycles. The specific medicines used in these treatments include various drugs like ADCETRIS, Doxorubicin, Dexamethasone, Procarbazine, Bleomycin, Vincristine, Prednisone, Dacarbazine, Etoposide, and Cyclophosphamide, given as infusions or tablets.

Throughout the treatment period and afterwards, you would have regular appointments for check-ups. These visits will involve blood tests, scans like CT or PET scans, and physical examinations to assess how the treatment is working and to monitor for any side effects. You might also fill out questionnaires about your quality of life.

The study will follow your health for an extended period, likely several years, to see how well the treatment keeps the cancer away, how it affects your overall health, and if there are any long-term effects. The exact number of visits and the full duration of follow-up will be explained by the study team.

Potential risks and benefits

Taking part in a study like this means you would receive one of two established treatments for Hodgkin lymphoma. The potential benefits include receiving careful monitoring and access to a well-researched treatment. However, all medical treatments carry potential risks, and the medicines used in this study (chemotherapy) can have side effects. These can range from common issues like feeling sick or tired, hair loss, and increased risk of infection, to more serious effects. The study aims to understand these side effects better for each treatment. You will be fully informed about all known risks before making your decision. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway
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Unverified
Austria
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Unverified
Netherlands
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Unverified
Germany
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Unverified
Denmark
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Unverified
Sweden

Common questions

What is Hodgkin lymphoma?

Hodgkin lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.

What does 'advanced stage' mean?

Advanced stage means the lymphoma has spread beyond its original location to other parts of your body.

What are BEACOPP and BrECADD?

These are names for two different combinations of medicines (chemotherapy regimens) used to treat Hodgkin lymphoma.

Will I get to choose which treatment I receive?

No, this is a 'randomised' study, meaning a computer randomly assigns you to one of the treatment groups, like flipping a coin.

How long will I be involved in the study?

The treatment phase usually lasts a few months, but your health will be monitored, and you'll have follow-up appointments for several years after that.