HOVON 178 WM: A prospective phase I/II trial of epcoritamab in patients with relapsed or refractory Waldenstrom’s macroglobulinemia
This research, called HOVON 178 WM, is a study for people with a specific type of blood cancer named Waldenstrom’s macroglobulinemia. This is for patients whose cancer has either returned after previous treatment or hasn’t responded well to other therapies. The study is testing a new drug called epcoritamab. We want to find out the best and safest dose of epcoritamab and see how well it works in shrinking the cancer. Researchers will also look at how long the treatment's effects last, how patients feel during the treatment, and any side effects. This study aims to find a new way to help people with this condition when other treatments haven't been successful.
At a glance
What is this study about?
This study is looking into a new medication called epcoritamab for people who have Waldenstrom’s macroglobulinemia, a type of slow-growing blood cancer. This research is specifically for patients whose cancer has either returned after they've already had treatment, or for those whose cancer hasn't responded to the treatments they've tried. The main goal is to see if epcoritamab can help shrink or control the cancer, and to understand its side effects.
The study has two main parts. In the first part (Phase Ib), doctors will carefully test different doses of epcoritamab to find the safest and most effective amount. Once the best dose is found, the second part of the study (Phase II) will focus on how well this treatment works. Researchers will be looking to see if the medicine leads to a significant improvement in the patient's condition, meaning the cancer shrinks or goes away.
Beyond simply checking if the cancer responds, the study will also look at other important things. This includes how long any improvements last, how quickly the medicine starts to work, and the overall health and quality of life for patients receiving the treatment. Safety is a key focus, so any side effects will be closely monitored. This research aims to find a new and effective treatment option for those with Waldenstrom’s macroglobulinemia when other options have been exhausted.
Key takeaways
- Tests a new drug (epcoritamab) for Waldenstrom’s macroglobulinemia.
- For patients whose cancer has returned or didn't respond to other treatments.
- Aims to find the safest dose and see how well it shrinks cancer.
- Will monitor side effects, how long effects last, and overall health.
- Patients can withdraw from the study at any time.
Who may be eligible?
To be part of this study, you need to be an adult, at least 18 years old. Both men and women can take part. The most important requirement is that you must have Waldenstrom’s macroglobulinemia.
Specifically, your cancer must be in a situation where it has either come back after you've already had some treatment, or it hasn't responded well to other treatments you've tried. The doctors involved in the study will need to check your medical history and current health carefully to make sure the study medication is suitable and safe for you.
There might be other health conditions or medications that would prevent someone from joining, but these will be discussed in detail by the study team. It's crucial that everyone in the study meets all the specific requirements to ensure their safety and the reliability of the study results.
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?
- Do you have Waldenstrom’s macroglobulinemia?
- Has your cancer come back after treatment or not responded to previous treatments?
- Are you able to attend regular clinic appointments for monitoring?
What does participation involve?
If you decide to take part in this study, you'll receive the new medication, epcoritamab. The exact number of visits to the clinic will vary, especially at the beginning, as doctors need to monitor you closely to find the best dose and watch for any side effects. You'll have regular check-ups, which will include physical exams, blood tests, and other medical assessments to see how you're responding to the treatment and identify any changes in your health.
The study treatment involves cycles of epcoritamab. The medication will be given for a period of time, and doctors will assess your progress after about 12 cycles. The total length of your participation can vary, as it depends on how you respond to the medication and whether your cancer stays under control. Even after you stop the study treatment, you may have follow-up visits to monitor your long-term health and the lasting effects of the treatment.
Potential risks and benefits
Locations (3)
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Common questions
What is Waldenstrom’s macroglobulinemia?
It's a rare type of slow-growing cancer that affects certain white blood cells and produces a high amount of a specific protein in the blood.
What does 'relapsed or refractory' mean?
It means your cancer has either come back after treatment or hasn't responded to previous treatments you've tried.
What is epcoritamab?
It's the new medicine being tested in this study to see if it can help treat Waldenstrom’s macroglobulinemia.
Will I know if the medicine is working?
The study doctors will conduct regular tests and assessments to monitor your condition and will discuss your progress with you.
Can I continue my regular medications?
You'll need to tell the study team about all medications you take. They will advise if any need to be stopped or changed during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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