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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

This research study is for people in the UK who have advanced Hodgkin Lymphoma, a type of cancer that affects the immune system. Doctors are comparing a newer treatment called A+AVD with the standard treatment known as ABVD. Both treatments are combinations of different medicines given through a drip. The main goal is to find out if A+AVD is more effective at preventing the cancer from growing or coming back, looking at how long people live without their disease getting worse. They will also look at how long people live overall. This is a Phase 3 trial, meaning it's a final step to confirm if this new treatment is better and safer before it can be widely used.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Takeda Development Center Americas Inc.
Enrolment target
448
Start
06 Feb 2024

What is this study about?

This clinical trial is designed for people who have advanced classical Hodgkin Lymphoma, which is a type of cancer that starts in white blood cells called lymphocytes. The study is comparing two different combinations of medicines used as a first treatment. One combination is called ABVD, which is a standard treatment doctors often use for this condition. The other is a newer combination called A+AVD.

The main reason for this study is to see if the A+AVD treatment can work better than ABVD. 'Work better' in this case means being more successful at keeping the cancer under control and stopping it from growing or coming back. This is measured by how long people can live without their cancer getting worse, which doctors call 'progression-free survival'. The study will also be looking at overall survival, which means how long people live after starting treatment.

By comparing these two treatments, researchers hope to find new and improved ways to treat advanced Hodgkin Lymphoma. This is important because finding more effective treatments can lead to better health and longer lives for people living with this cancer.

Key takeaways

  • This study compares a new treatment (A+AVD) to a standard one (ABVD) for advanced Hodgkin Lymphoma.
  • The main goal is to see if A+AVD can better control the cancer and help people live longer.
  • This is a Phase 3 trial, the final step before a new treatment might become widely available.
  • Participants must be 18 years or older and have advanced classical Hodgkin Lymphoma.
  • You will receive treatments via infusion and have regular health checks and scans.
  • You can discuss this trial with your doctor and decide if it's right for you.

Who may be eligible?

This study is looking for adult patients, meaning anyone 18 years old or older, who have been diagnosed with advanced classical Hodgkin Lymphoma. Both men and women are welcome to take part in this research.

Beyond simply having the right diagnosis and being an adult, there will be other specific health checks and tests to make sure that the treatment could be safe and effective for you. These will be explained in detail by your doctor if you express an interest in the trial.

It's important that you discuss your full medical history with your doctor to understand if you meet all the criteria for joining the study.

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 18 years old or older?
  2. Have you been diagnosed with advanced classical Hodgkin Lymphoma?
  3. Are you able to attend regular hospital or clinic appointments?
  4. Are you willing to have regular medical tests, including blood tests and scans?
  5. Have you discussed your complete medical history with your doctor regarding this study?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive treatment through infusions (drips) of the study medication. These treatments will be given over a period, and you will have regular visits to the clinic or hospital. During these visits, the study team will carry out various tests and assessments. This includes physical examinations, blood tests, and scans (like CT scans) to monitor your health and how the treatment is working. You'll also be asked about any side effects you might experience.

The total duration of your participation in the study will involve the treatment period itself, followed by a period of close monitoring and follow-up appointments. These follow-up visits are important to understand the long-term effects of the treatment and will continue for several years after your treatment has finished.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. The potential benefit of this study is that the new A+AVD treatment might be more effective at controlling your cancer than the standard treatment. However, there's no guarantee, and there could be side effects from either treatment, which your doctors will monitor closely. You will be fully informed about all known risks before deciding, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Denmark
  • Unverified
    Hungary
  • Unverified
    Italy
  • Unverified
    Belgium
  • Unverified
    Spain
  • Unverified
    France
  • Unverified
    Norway
  • Unverified
    Poland
  • Unverified
    Czechia

Common questions

What is Hodgkin Lymphoma?

Hodgkin Lymphoma is a type of cancer that develops in the immune system, specifically in a part of the white blood cells called lymphocytes.

What does 'Phase 3 Trial' mean?

A Phase 3 trial is a big study that compares a new treatment to the best existing treatment. It's the final step to see if the new treatment is better and safer before it can be widely used.

Will I know which treatment I'm getting?

Yes, in this 'open-label' study, both you and your doctors will know whether you are receiving the standard ABVD treatment or the newer A+AVD treatment.

How long will I be involved in the study?

Your involvement will include the treatment period and then a long-term follow-up period, possibly several years, to monitor your health and the treatment's effects.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting the standard medical care you receive.

How to find out more

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

Discussion

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