This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). The study is investigating the safety and effectiveness of a new treatment combination. The treatment being tested is called Epcoritamab (GEN3013), which is a type of medicine known as a bispecific antibody. This new treatment will be combined with a standard treatment regimen known as R-CHOP. R-CHOP includes a combination of medicines: rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone. The study will compare the effects of Epcoritamab with R-CHOP against the effects of R-CHOP alone.
The purpose of this study is to determine if adding Epcoritamab to the standard R-CHOP treatment can help patients with newly diagnosed DLBCL live longer without their disease getting worse. Participants in the study will receive either the combination of Epcoritamab and R-CHOP or just R-CHOP. The study will involve several cycles of treatment, with Epcoritamab being given as a subcutaneous injection (an injection under the skin) and the R-CHOP medicines being given as intravenous infusions (medicines delivered directly into a vein).
The study will last for a period of time, during which participants will be monitored for any changes in their health and the progression of their disease. The goal is to see if the new treatment combination can improve the time patients live without their disease worsening, compared to the standard treatment alone. This study is important for understanding how to better treat DLBCL and potentially improve outcomes for patients with this type of cancer.
1joining the study
Upon joining the study, participation is confirmed for individuals aged 18 to 79 with a life expectancy of at least 12 months.
Participants must have a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (DLBCL) and an International Prognostic Index (IPI) score between 2 and 5.
2treatment initiation
The treatment begins with 6 cycles of a regimen known as R-CHOP, which includes the following medications: rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone.
Rituximab is administered as an intravenous infusion, cyclophosphamide and doxorubicin hydrochloride are given as intravenous injections, vincristine sulfate is provided as an intravenous infusion, and prednisone is taken orally.
3additional treatment with epcoritamab
After completing the 6 cycles of R-CHOP, participants receive 2 additional cycles of epcoritamab.
Epcoritamab is administered as a subcutaneous injection.
4monitoring and follow-up
Throughout the study, participants are monitored for disease progression and overall health.
The primary goal is to assess whether the addition of epcoritamab improves progression-free survival compared to R-CHOP alone.
5completion of study
The study is expected to conclude by August 2029.
Participants’ health outcomes, including progression-free survival and overall survival, are evaluated to determine the effectiveness of the treatment.
Who Can Join the Study?
Must be between 18 and 79 years old and expected to live for at least 12 more months.
Planned to receive treatment with 6 cycles of standard R-CHOP, which is a combination of medicines used to treat certain types of cancer.
Must have tumor tissue available for testing, either from a previous sample or a new one collected during the screening process. If using an old sample, it should have been collected within 8 weeks before starting the treatment.
Must have an IPI score of 2-5. The IPI score is a way to measure the risk level of the lymphoma, with higher numbers indicating a higher risk. Only about 30% of participants can have a score of 2.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. DLBCL is a type of cancer that affects the lymphatic system, which is part of the body’s immune system.
Patients who have already received treatment for DLBCL before the study cannot join. This means if you have been treated for this specific type of cancer in the past, you are not eligible.
Patients with other serious health conditions that might interfere with the study cannot participate. This includes any major illnesses that could affect the results or your safety during the study.
Patients who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
Patients who are unable to follow the study procedures or attend the required visits cannot participate. This means if you cannot commit to the study schedule, you are not eligible.
Patients who have participated in another clinical trial within a certain period before this study cannot join. This is to avoid any interference from other treatments or medications.
Epcoritamab is a medication being studied for its potential to help treat diffuse large B-cell lymphoma (DLBCL). In this trial, it is being tested to see if it can improve the time patients live without their disease getting worse when added to a standard treatment regimen. Epcoritamab is given in combination with other medications to see if it can enhance the overall effectiveness of the treatment.
R-CHOP is a standard treatment regimen for DLBCL. It is a combination of several medications that work together to attack cancer cells. R-CHOP includes a mix of chemotherapy drugs and a targeted therapy, which helps to destroy cancer cells and stop them from growing. This regimen is commonly used as a first-line treatment for patients with this type of lymphoma.
Rituximab is a medication that is part of the R-CHOP regimen. It is a type of targeted therapy known as a monoclonal antibody. Rituximab works by attaching to a specific protein on the surface of cancer cells, helping the immune system to recognize and destroy these cells. In this trial, rituximab is also given after the initial treatment cycles to help maintain the response to therapy.
Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. DLBCL can occur in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease progresses quickly, requiring prompt medical attention. It is the most common form of non-Hodgkin lymphoma and can vary in its presentation and progression among individuals.
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