All studies
RecruitingPHASE3INTERVENTIONAL

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

This study, called RADAR, is for patients aged 16-69 with early-stage Hodgkin Lymphoma. It aims to find the most effective treatment for this type of cancer. Participants will receive one of two chemotherapy treatments: either standard ABVD or a new treatment called A2VD, which includes a drug called brentuximab vedotin. We'll use special PET-CT scans during treatment to see how well the cancer is responding. Based on these scans, your doctor might adjust your treatment, which could include more chemotherapy or radiotherapy. We will follow everyone for at least 5 years after treatment to monitor their health and the long-term effects of the treatments. This study is happening in several countries, including the UK, to gather enough information.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
University College, London
Enrolment target
1,042
Start
14 Apr 2022
Estimated completion
01 Sep 2032

What is this study about?

Hodgkin Lymphoma is a type of cancer that affects the lymphatic system, which is part of your body's immune system. When it's caught at an early stage, there are good treatment options, usually involving chemotherapy. This particular study, called RADAR, is looking at how best to treat early-stage Hodgkin Lymphoma. We want to find out if a newer treatment combination, A2VD, is more effective or has fewer side effects than the standard treatment, ABVD.

In this study, patients will be randomly assigned to receive either the standard ABVD chemotherapy or the A2VD chemotherapy. The A2VD treatment includes a drug called brentuximab vedotin, which is designed to target cancer cells more precisely. During your treatment, you'll have special scans, called PET-CT scans, after the first two cycles of chemotherapy. These scans will help doctors see how well your cancer is responding to the treatment. Depending on the scan results, your treatment plan might be adjusted, which could mean you have more chemotherapy or some radiotherapy targeting the areas affected by cancer.

Taking part in a clinical trial like RADAR helps doctors learn more about diseases and improve treatments for future patients. By comparing these two treatments and carefully monitoring patients, we hope to find a way to make Hodgkin Lymphoma treatment even more successful. Everyone in the study will be looked after by a team of specialist doctors and nurses, and we'll keep in touch with you for at least five years after your treatment finishes to see how you're doing in the long term.

Key takeaways

  • This study compares two chemotherapy treatments for early-stage Hodgkin Lymphoma.
  • You'll receive either standard ABVD or the newer A2VD treatment.
  • Treatment is adjusted based on how your cancer responds to early scans.
  • You'll be followed by the study team for at least 5 years after treatment.
  • Participation helps improve future treatments for Hodgkin Lymphoma.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men and women aged between 16 and 69 years old who have been diagnosed with early-stage classical Hodgkin Lymphoma. Your cancer needs to be in specific areas of the body, generally above the diaphragm (the breathing muscle under your lungs) and not causing large masses in your chest, nor widespread in other organs like your bone marrow. You also need to be generally well enough to go through chemotherapy.

There are certain reasons why you might not be able to join the study. For example, if you've already had treatment for Hodgkin Lymphoma, have a different type of Hodgkin Lymphoma, or if the cancer is in areas not covered by the study criteria. Also, if you have other serious health conditions, like certain heart problems, kidney issues, or nerve damage, or another cancer diagnosed recently, you might not be able to take part. It's important that you understand and are able to follow the study's instructions, including any advice about contraception.

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.

  1. Are you between 16 and 69 years old?
  2. Have you been diagnosed with early-stage classical Hodgkin Lymphoma?
  3. Is your cancer located in certain areas, generally above your diaphragm, without large masses in your chest?
  4. Are you generally well enough to receive chemotherapy?
  5. Have you NOT had previous treatment for Hodgkin Lymphoma (except short steroid courses)?
  6. Do you NOT have other serious health conditions like significant heart, kidney, or nerve problems?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly assigned to one of two treatment groups: either ABVD or A2VD chemotherapy. This is like flipping a coin, so it's fair. You'll receive your chemotherapy over several cycles, usually 3 to 4 in total. You'll have regular appointments at the hospital for your treatment and to check how you're doing. This will include blood tests and physical examinations.

You'll have a PET-CT scan after two cycles of treatment. This scan helps doctors decide if your treatment needs to be adjusted. Depending on the results, you might have one more cycle of chemotherapy, two more cycles plus some radiotherapy, or if the treatment isn't working as hoped, you might stop the study treatment and discuss other options with your doctor. You may also have another PET-CT scan later. After your treatment ends, the study team will follow up with you for at least 5 years. This involves regular check-ups to monitor your health and ensure you're doing well. The total duration of active treatment is usually a few months, followed by the long-term follow-up.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving a new and potentially more effective treatment for your Hodgkin Lymphoma, or having your treatment closely monitored and adjusted based on your body's response. You will also be contributing to medical knowledge that could help future patients. However, like all medical treatments, there are potential risks. Chemotherapy can cause side effects, and the extra drug in A2VD (brentuximab vedotin) has its own set of possible side effects. These will be fully explained to you before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (71)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Stanford University - (Stanford Cancer Institute)
    Verified postcode
    Stanford, United States· Recruiting
  • University of Miami School of Medicine
    Verified postcode
    Miami, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • Royal North Shore Hospital
    Unverified
    Saint Leonards, Australia· Recruiting
  • Townsville University Hospital
    Verified postcode
    Townsville, Australia· Recruiting
  • Royal Adelaide Hospital
    Verified postcode
    Adelaide, Australia· Recruiting
  • Box Hill Hospital
    Verified postcode
    Box Hill, Australia· Recruiting
  • Royal Brisbane and Women's Hospital
    Verified postcode
    Brisbane, Australia· Recruiting
  • Royal Darwin Hospital
    Verified postcode
    Darwin, Australia· Recruiting
  • Liverpool Hospital
    Verified postcode
    Liverpool, Australia· Recruiting
  • Sunshine Hospital (Western Health)
    Verified postcode
    Melbourne, Australia· Recruiting
  • Concord Repatriation General Hospital
    Verified postcode
    Sydney, Australia· Recruiting

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 immune system. It often begins in the lymph nodes.

What is a PET-CT scan?

A PET-CT scan is a special imaging test that combines two types of scans. It helps doctors see how active cancer cells are in your body and where they are located.

What does 'randomised' mean?

Randomised means that you will be put into one of the treatment groups by chance, like drawing names from a hat. This makes the study fair and helps us compare the treatments accurately.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, which means both you and your doctors will know which chemotherapy treatment you are receiving (ABVD or A2VD).

How long will I be followed after treatment?

You will be followed up by the study team for at least 5 years after your treatment has finished to monitor your health and long-term progress.

How to find out more

RADAR Trial Coordinator

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Brentuximab Vedotin in Early Stage Hodgkin Lymphoma…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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