Epcoritamab + EPOCH-R for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining epcoritamab with standard chemotherapy treatment (EPOCH-R) is safe and effective for individuals with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a specialized antibody that aids the immune system in targeting and killing cancer cells. Participants recently diagnosed with this type of lymphoma and with minimal prior treatment may be suitable for the study. The goal is to assess whether adding epcoritamab can enhance the treatment's effectiveness and improve cancer management. As a Phase 2 trial, the research focuses on measuring the treatment's efficacy in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to understand any potential interactions or requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining epcoritamab with EPOCH-R, a common chemotherapy treatment, is generally safe and manageable for treating aggressive B-cell non-Hodgkin lymphoma. In earlier studies, most patients experienced some side effects, but these were usually manageable. Fatigue and nausea were common, typical of cancer treatments.
Epcoritamab has been tested in other studies and was found to be well-tolerated. Most patients experienced mild to moderate side effects, with serious side effects being less common.
The safety of EPOCH-R is well-known, as it is a standard treatment. It has been widely used and is considered safe, although it can cause side effects like low blood counts or infections, similar to many cancer treatments.
Overall, research suggests that combining epcoritamab with EPOCH-R may be safe, but like any treatment, there are risks. Participants in trials help researchers improve the safety of these treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Epcoritamab for Non-Hodgkin's Lymphoma because it offers a novel approach compared to traditional treatments like R-CHOP therapy. Unlike these conventional treatments, Epcoritamab is a bispecific antibody that uniquely targets CD3 and CD20 proteins on cancer cells, enhancing the immune system's ability to attack lymphoma cells directly. Additionally, its subcutaneous administration allows for a more targeted delivery, potentially reducing side effects and improving patient comfort. This innovative mechanism and delivery method could lead to more effective and tolerable treatment options for patients.
What evidence suggests that this trial's treatments could be effective for aggressive B-cell non-Hodgkin lymphoma?
This trial will evaluate the combination of Epcoritamab with EPOCH-R for treating aggressive B-cell non-Hodgkin lymphoma. Studies have shown that Epcoritamab, which participants in this trial will receive, yields promising results, with about 83% of patients who had a complete response remaining cancer-free for two years. EPOCH-R, which includes drugs like rituximab and cyclophosphamide, has demonstrated a 68% overall response rate, with 45% of patients experiencing complete or nearly complete disappearance of cancer. The combination aims to leverage Epcoritamab's ability to connect T-cells and cancer cells to enhance the immune system's response. These findings suggest that adding Epcoritamab to EPOCH-R could improve outcomes for patients with this type of lymphoma.13467
Who Is on the Research Team?
Mengyang Di, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for patients with aggressive B-cell non-Hodgkin lymphoma. Participants should be suitable for the EPOCH-R chemotherapy regimen and willing to undergo various tests like echocardiography, PET scans, CT scans, and bone marrow procedures. Specific inclusion or exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rituximab, prednisone, etoposide, doxorubicin, cyclophosphamide, and epcoritamab over 6 cycles of 21 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Doxorubicin
- Epcoritamab
- Etoposide
- Prednisone
- Rituximab
Trial Overview
The trial is testing epcoritamab combined with a chemo cocktail (EPOCH-R) against aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is an antibody that targets cancer cell antigens CD3/CD20 to hinder their growth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive rituximab IV on day 1, prednisone PO BID on days 1-5, etoposide IV and doxorubicin on days 1-4 and cyclophosphamide IV on day 5 of each cycle. Patients also receive epcoritamab SC on days 8 and 15 of cycle 1, days 1, 8 and 15 of cycles 2-4 and day 1 of cycles 5-6. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and receive fludeoxyglucose and undergo PET scan, CT scan, bone marrow biopsy and aspirate (if needed), and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Citations
Study Details | NCT07097363 | Epcoritamab With Dose ...
Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma. Detailed Description.
Efficacy and Safety of Rituximab plus Modified EPOCH ...
The overall response rate was 68%, with 45% achieving complete response (CR) or unconfirmed CR and 23% achieving partial response. With a median ...
Outcomes of patients with relapsed or refractory primary ...
After frontline treatment with DA-EPOCH-R, 62% of patients included in this analysis did not achieve a CR.
Two Data Analyses From Clinical Trials Show Epcoritamab ...
Among complete responders, an estimated 83% remained in remission after two years. Separately, three-year follow-up results from the Phase 2 ...
5.
onclive.com
onclive.com/view/epcoritamab-plus-r-ice-yields-high-cr-rates-and-improves-transplant-eligibility-in-r-r-dlbclEpcoritamab Plus R-ICE Yields High CR Rates and ...
Epcoritamab combined with R-ICE therapy achieved high response rates in relapsed/refractory DLBCL patients eligible for ASCT, with an 87% ORR ...
6.
ashpublications.org
ashpublications.org/blood/article/146/18/2177/546196/Real-world-outcomes-of-patients-with-aggressive-BReal-world outcomes of patients with aggressive B-cell ...
A total of 201 of 245 patients (82.0%) were efficacy-evaluable (124 treated with epcoritamab [80%], and 77 treated with glofitamab [87%]).
Epcoritamab in relapsed/refractory large B-cell lymphoma
We report long-term efficacy and safety results in patients with LBCL (N = 157; 25.1-month median follow-up). As of April 21, 2023, overall ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.