A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
This study is for adults newly diagnosed with Diffuse Large B-cell Lymphoma (DLBCL), a fast-growing type of blood cancer. We want to see how a new drug called epcoritamab, when given alongside a standard treatment called R-CHOP, compares to R-CHOP on its own. R-CHOP is a combination of different chemotherapy drugs and steroids. We will be checking how these treatments affect the lymphoma. Participants will receive either the new drug combination or R-CHOP alone. This research aims to find better ways to treat DLBCL. It involves regular hospital visits, medical checks, and blood tests to monitor progress and side effects, and is taking place in many hospitals worldwide.
At a glance
What is this study about?
This study is designed for adults who have recently been diagnosed with a type of blood cancer called Diffuse Large B-cell Lymphoma, or DLBCL. This is a fast-growing cancer that affects white blood cells called B-cells, which are part of your immune system. The main goal of this research is to understand if adding a new trial drug, called epcoritamab, to the standard treatment (known as R-CHOP) can improve how well the lymphoma responds. R-CHOP is a combination of several well-known drugs used to treat lymphoma, including rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.
Epcoritamab is an investigational drug, meaning it's still being tested and is not yet available as a standard treatment. In this study, some participants will receive epcoritamab along with R-CHOP, followed by more epcoritamab. Others will receive only R-CHOP, followed by rituximab. Doctors will regularly check everyone's progress to see how their lymphoma responds to the treatment and to monitor for any side effects. This is a 'Phase 3' study, which means it’s one of the final stages of testing, comparing a new treatment against the best existing treatment to see if it’s more effective or safer.
Around 900 adults with newly diagnosed DLBCL will take part in this study at many different hospitals and clinics across the world. By carefully comparing these treatment approaches, researchers hope to find better and more effective ways to treat DLBCL, ultimately improving outcomes for patients in the future.
Key takeaways
- This study is for adults with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL).
- It tests a new drug, epcoritamab, in combination with standard R-CHOP treatment.
- Participants will receive either the new combination or R-CHOP alone.
- The goal is to find out if the new treatment is more effective.
- Participation involves regular hospital visits, tests, and careful monitoring.
Who may be eligible?
To join this study, you need to be an adult between 18 and 79 years old who has recently been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL). The lymphoma must be a specific type that the doctors can identify through a biopsy, and it should produce a certain marker called CD20. You also need to be well enough to receive treatment, which doctors measure using a scale called ECOG performance status (you typically need a score of 0-2).
Doctors will also consider how advanced your lymphoma is, using a system called the IPI score. Your lymphoma needs to meet certain criteria for this score. It's important that your doctors believe you are suitable for the standard R-CHOP treatment, which is part of this study. The study cannot accept people with certain other types of lymphoma or if your lymphoma has specific features that don't fit the study criteria.
Basically, if you're an adult with newly diagnosed DLBCL that's CD20 positive, are fit enough for treatment, and your specific lymphoma type matches the study's requirements, you might be able to take part.
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 an adult between 18 and 79 years old?
- Have you recently been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)?
- Have your doctors confirmed your DLBCL has a specific marker called CD20?
- Are you generally well enough to receive treatment, as assessed by your doctor?
- Do you have an IPI score between 2 and 5?
What does participation involve?
If you join this study, your treatment will be divided into cycles, each lasting 21 days. Depending on which group you are assigned to, you will receive either epcoritamab combined with R-CHOP (an injection under the skin for epcoritamab, and some drugs given into a vein and some by mouth for R-CHOP) or R-CHOP alone (some drugs into a vein and some by mouth). Following the main treatment, you will continue with either epcoritamab or rituximab, depending on your assigned group.
You will have regular visits to an approved hospital or clinic throughout the study. These visits will involve medical assessments, blood tests, and you may be asked to fill out questionnaires. These checks are to monitor how well the treatment is working, to look for any side effects, and to ensure your safety. Taking part might mean more hospital visits and tests than if you were having standard care outside of a trial. The exact total duration of your participation will depend on how you respond to treatment and the study’s protocol, but it will involve continued monitoring over time.
Potential risks and benefits
Locations (331)
- University of Arizona Cancer Center - North Campus /ID# 227463Verified postcodeTucson, United States
- Yuma Regional Medical Center /ID# 261527Verified postcodeYuma, United States
- University of Arkansas for Medical Sciences /ID# 225703Verified postcodeLittle Rock, United States
- CBCC Global Research, Inc. /ID# 262037Verified postcodeBakersfield, United States
- Alta Bates Summit Medical Center for Research /ID# 229427Verified postcodeBerkeley, United States
- Orange Coast Memorial Medical Center /ID# 229632Verified postcodeFountain Valley, United States
- Providence - St. Jude Medical Center /ID# 262042Verified postcodeFullerton, United States
- Saddleback Memorial Medical Center /ID# 229631Verified postcodeLaguna Hills, United States
- Long Beach Memorial Medical Ct /ID# 228996Verified postcodeLong Beach, United States
- Cancer and Blood Speciality Clinic - Los Alamitos /ID# 262032Verified postcodeLos Alamitos, United States
- University of Southern California /ID# 225443Verified postcodeLos Angeles, United States
- University of California, Los Angeles /ID# 226887Verified postcodeLos Angeles, United States
Common questions
What is DLBCL?
DLBCL stands for Diffuse Large B-cell Lymphoma. It's a fast-growing cancer that affects a type of white blood cell called B-cells, which are important for your immune system.
What is R-CHOP?
R-CHOP is a common treatment for lymphoma. It's a combination of several drugs: rituximab, cyclophosphamide, doxorubicin (also called hydroxydaunorubicin), vincristine, and prednisone.
What is epcoritamab?
Epcoritamab is a new drug being tested in this study. It's an 'investigational drug,' meaning it's not yet approved for general use but researchers are hopeful it could help treat DLBCL.
Will I definitely get the new drug?
No, you might not. Participants will be put into different groups by chance. Some will get the new drug combination, and others will get the standard R-CHOP treatment. This is to fairly compare the two.
How long will I be in the study?
The study involves treatment cycles of 21 days, followed by ongoing monitoring. The overall duration will depend on your individual response and the study’s specific plan, which your doctor can explain.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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