Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma
This important study is for older people newly diagnosed with a type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL). These are patients who, due to their age or other health conditions, aren't able to have the usual strong chemotherapy. The study is investigating a new medication called epcoritamab, which has been tested before. It will look at how effective and safe epcoritamab is when given alone, or when combined with another drug called lenalidomide. Everyone in the study will receive active treatment. There's an equal chance of receiving just epcoritamab, or epcoritamab plus lenalidomide, to help find the best way to treat this cancer more gently but effectively for these patients.
At a glance
What is this study about?
This study is about finding new and gentler ways to treat a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). This kind of cancer affects white blood cells and is often treated with strong chemotherapy. However, some older patients or those with other health problems might not be able to have these standard, powerful treatments because of the side effects.
The main goal of this study is to see how well a new drug called epcoritamab works for these patients, and how safe it is. Epcoritamab is a special type of medication that helps your immune system fight cancer. It's been studied in other trials already. The study will also look at whether combining epcoritamab with another drug called lenalidomide works even better.
All patients who join this study will receive one of the active treatments – either epcoritamab alone or epcoritamab with lenalidomide. This means no one will receive a placebo (a dummy treatment). Scientists hope to find a treatment option that is effective against DLBCL but is also well-tolerated by older patients who can't have the usual strong chemotherapy.
Key takeaways
- This study is testing new treatments for a type of blood cancer (DLBCL).
- It's for older patients who cannot have standard strong chemotherapy.
- All participants will receive an active experimental treatment, no placebo.
- The new drug, epcoritamab, may be given alone or with lenalidomide.
- The aim is to find effective and well-tolerated treatments for these patients.
Who may be eligible?
This study is looking for older patients who have recently been diagnosed with a type of blood cancer called Diffuse Large B-Cell Lymphoma. You might be suitable if your doctors believe you can't have standard strong chemotherapy, perhaps because you are 80 years old or more, or you are 75 or older and have other health issues that make strong chemotherapy too risky.
You would need to have specific types of cells (CD20+) in your lymphoma and the cancer should be at a certain stage (Stage II to IV). Your general health and organ function would be checked by blood tests and other assessments. You also need to have areas of cancer that can be measured, and your doctors will need a sample of your cancer tissue.
There are also reasons why you might not be able to join. For example, if you have a serious active infection like COVID-19, or severe heart problems. Certain past medical treatments or surgeries within a recent timeframe might also mean you can't take part. The study team will review all your medical information carefully to see if this study is right for 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 newly diagnosed with Diffuse Large B-Cell Lymphoma?
- Are you 80 years old or over, OR 75 or over with other health conditions that prevent standard chemotherapy?
- Do you have certain types of cancer cells (CD20+)?
- Is your cancer at stage II, III, or IV?
- Do you have measurable areas of cancer?
What does participation involve?
If you decide to take part in this study, you will be given epcoritamab, either on its own or with lenalidomide. The study involves regular visits to the hospital for check-ups, blood tests, and to receive your treatment. These visits will help doctors monitor how you are doing, track the progress of your cancer, and check for any side effects. You'll have physical examinations and your medical team will ask you about any symptoms you experience. The treatment will continue for a period, and there will be follow-up appointments even after active treatment ends to see how you are doing in the longer term. The total duration of your participation will be explained by the study team.
Potential risks and benefits
Locations (74)
- UW Cancer Center at ProHealth CareVerified postcodeWaukesha, United States
- Kepler UniversitätsklinikumVerified postcodeLinz, Austria
- LKH - Universitätsklinikum der PMU SalzburgVerified postcodeSalzburg, Austria
- Klinikum Wels-Grieskirchen GmbHVerified postcodeWels, Austria
- Institut Jules BordetVerified postcodeAnderlecht, Belgium
- ZNAVerified postcodeAntwerp, Belgium
- UZ BrusselsVerified postcodeJette, Belgium
- UZ LeuvenVerified postcodeLeuven, Belgium
- AZ DeltaVerified postcodeRoeselare, Belgium
- VitazVerified postcodeTemse, Belgium
- AZ Turnhout - Campus Sint-ElisabethVerified postcodeTurnhout, Belgium
- Fakultni nemocnice Hradec KraloveVerified postcodeHradec Králové, Czechia
Common questions
What is Diffuse Large B-Cell Lymphoma?
It's a fast-growing type of cancer that affects white blood cells called lymphocytes, which are part of your immune system.
What is epcoritamab?
It's a new drug designed to help your body's immune system find and fight the cancer cells.
Will I get a placebo (dummy treatment)?
No, everyone in this study will receive one of the active treatments being tested.
Why is this study only for older patients?
It's for older patients or those with other health issues who can't tolerate the strong standard chemotherapy and need gentler, effective options.
How long will I be in the study?
The study team will explain the specific duration of treatment and follow-up during your initial discussions.
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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