A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
This study is looking into a new treatment called epcoritamab for a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). This is for patients whose cancer hasn't improved or has returned after at least one previous treatment. The study wants to find out if epcoritamab, also known as EPKINLY™, works better and is safer than standard chemotherapy options (R-GemOx or BR). All participants will be randomly assigned to receive either the new medicine or established chemotherapy. This trial is designed for people who have already tried or can't have a specific type of stem cell transplant. It aims to gather important information over several years to help future patients.
At a glance
What is this study about?
This study is a research trial exploring a new medication called epcoritamab, which is also known as EPKINLY™ or GEN3013. It's designed for people in the UK and worldwide who have a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). This type of lymphoma affects white blood cells and is considered 'relapsed or refractory', meaning it has either come back after past treatments or hasn't responded to previous therapy. The main goal is to see if epcoritamab is a more effective and safer option for these patients than the chemotherapy treatments that are currently used.
Participants in this study will be split into two groups by chance (like flipping a coin). One group will receive epcoritamab, and the other will receive one of two common chemotherapy treatments: R-GemOx or BR. Doctors will decide which chemotherapy is best for those in the chemotherapy group. Importantly, this study is for individuals who have already had or are unable to have a special type of stem cell transplant (called an autologous stem cell transplant or ASCT).
The study will follow participants for several years to carefully compare how well the treatments work against the lymphoma and to understand any side effects. The results will help doctors understand if epcoritamab could become a new standard treatment option for DLBCL patients in the future.
Key takeaways
- Compares a new drug (epcoritamab) with standard chemotherapy for DLBCL.
- For patients whose lymphoma has returned or not responded to previous treatment.
- Specifically for those who can't have or have had a stem cell transplant.
- Participants are randomly assigned to one of two treatment groups.
- Involves regular hospital visits for treatment and monitoring.
- Aims to find safer and more effective treatment options for the future.
Who may be eligible?
You might be able to join this study if you have Diffuse Large B-cell Lymphoma (DLBCL) that has either returned or hasn't responded to at least one previous treatment, including a specific type of antibody therapy. Your lymphoma cells must show a particular marker called CD20. You also need to be generally well enough to take part and have specific tests confirming your lymphoma is still present and can be measured. Your kidneys and liver also need to be working well.
On the other hand, you would not be able to join if your lymphoma has spread to your brain or spinal cord, or if you've already had a similar type of antibody treatment. If you've had major surgery recently, certain chemotherapy within the last month, or a specific type of cell therapy (CAR-T) recently, you wouldn't be eligible. Certain heart conditions or a history of seizures requiring daily medication would also prevent you from joining.
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.
- Do I have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not responded to past treatment?
- Have I had at least one previous cancer treatment, including an antibody drug called anti-CD20?
- Have I either failed a stem cell transplant or been told I can't have one?
- Am I generally well enough to take part in a study (doctors will check this)?
- Do I have detectable lymphoma that can be seen on scans?
- Do I have any significant heart problems or a history of seizures?
What does participation involve?
Taking part in this study involves several stages. First, there's a 'screening period' lasting about three weeks to ensure you meet all the requirements. If you're eligible, you'll be randomly assigned to either receive epcoritamab or one of the chemotherapy treatments. Epcoritamab is given as an injection under the skin, while chemotherapy is given through a drip into a vein.
Your treatment schedule will depend on which group you're in. If you receive epcoritamab, you'll have weekly injections for the first three months, then every other week for six months, and then once a month until your lymphoma gets worse or side effects become too difficult. If you receive chemotherapy, you'll have cycles of treatment over about four to four and a half months. You'll have regular hospital visits for your treatment, scans, blood tests, and to check how you're feeling. The study will continue to follow your health until your death, with the overall study lasting up to five years for the last person to join.
Potential risks and benefits
Locations (186)
- Indiana Blood and Marrow TransplantationVerified postcodeIndianapolis, United States
- Community Health Network Cancer Center NorthVerified postcodeIndianapolis, United States
- University of Kentucky Markey Cancer CenterVerified postcodeLexington, United States
- Henry Ford Health SystemVerified postcodeJackson, United States
- MMCORC Attn Delaney AndersonVerified postcodeSaint Louis Park, United States
- MD Anderson Cancer Center at CooperVerified postcodeCamden, United States
- Wake Forest Baptist HealthVerified postcodeWinston-Salem, United States
- The Christ Hospital Cancer CenterVerified postcodeCincinnati, United States
- TriHealth Cancer Institute- Good Samaritan HospitalVerified postcodeCincinnati, United States
- Brooke Army Medical CenterVerified postcodeFort Sam Houston, United States
- Community Cancer Trials of UtahVerified postcodeOgden, United States
- LDS HospitalVerified postcodeSalt Lake City, United States
Common questions
What is the new medicine, epcoritamab?
Epcoritamab is a new investigational treatment for lymphoma. It's designed to help your immune system fight the cancer.
Why is this study important?
This study helps us understand if epcoritamab is a better option for people with DLBCL whose cancer has returned or is hard to treat, especially if they can't have a stem cell transplant.
What does 'randomly assigned' mean?
It means you'll be put into one of the treatment groups by chance, like drawing names from a hat. Neither you nor your doctor can choose which group you're in.
Will I know which treatment I'm getting?
Yes, this is an 'open label' study, so you and your doctors will know whether you are receiving epcoritamab or standard chemotherapy.
How long will I be involved in the study?
The treatment part is usually several months, but you'll be followed up regularly for potentially several years, even after treatment ends, to monitor your health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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