Epcoritamab + R-CHOP for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for individuals with aggressive B-cell non-Hodgkin lymphoma, a cancer that begins in the lymphatic system. Researchers are examining the effectiveness of the drug epcoritamab (a type of immunotherapy) when combined with standard R-CHOP chemotherapy. The trial includes two groups, each receiving a slightly different dose of dexamethasone. Individuals with newly diagnosed, aggressive B-cell lymphoma who have not received previous treatments other than corticosteroids or radiation may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or certain investigational drugs, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining epcoritamab with R-CHOP chemotherapy is generally safe. In earlier studies, patients with aggressive non-Hodgkin's lymphoma tolerated this treatment well. Most side effects were manageable, and no new safety issues emerged. While side effects might occur, they are usually not serious and can be controlled. The evidence suggests this treatment is safe for those considering joining a trial. However, since reactions to treatments vary, healthcare professionals should monitor progress closely.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about epcoritamab combined with R-CHOP for treating Non-Hodgkin's Lymphoma because it adds a novel mechanism of action to the standard regimen. While traditional options like R-CHOP use chemotherapy to target cancer cells, epcoritamab is a bispecific antibody that targets CD3 and CD20, potentially enhancing the immune system's ability to fight the cancer. This dual-targeting approach could improve treatment effectiveness and outcomes for patients. Additionally, the study is exploring different doses of dexamethasone, which could optimize the treatment's efficacy and reduce side effects.
What evidence suggests that this trial's treatments could be effective for non-Hodgkin's lymphoma?
Research has shown that combining epcoritamab with R-CHOP chemotherapy yields promising results for treating aggressive B-cell non-Hodgkin lymphoma. Participants in this trial will receive this combination, with variations in dexamethasone dosing between the treatment arms. One study reported a 98% success rate, with many patients remaining cancer-free for over three years. Another study found that 87% of patients had no detectable cancer after treatment. These findings suggest that this combination is highly effective, particularly for patients who might not respond well to standard treatments, making it a hopeful option for those with this type of lymphoma.12456
Who Is on the Research Team?
Mwanasha Merrill, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults (18+) with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma, including certain subtypes like diffuse large B-cell lymphoma. Participants must not have had prior treatment for their lymphoma except steroids or one cycle of chemo and need to be well enough to carry out daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 8 cycles of R-CHOP chemotherapy combined with epcoritamab and dexamethasone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall response, progression-free survival, and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Epcoritamab
- R-CHOP
Trial Overview
The study tests a new drug called epcoritamab combined with standard R-CHOP chemotherapy versus R-CHOP alone in people with aggressive B-cell lymphomas. Patients are assigned to different groups and closely monitored using scans and blood tests.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive 8 cycles of rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) chemotherapy combined with epcoritamab. A modified dose of dexamethasone will be given in Cycle 2. Treatment includes six 21-day cycles: Cycle 1 consists of R-CHOP alone; Cycles 2-5 include R-CHOP on Day 1 with epcoritamab on Days 1, 8, and 15. In Cycle 2, dexamethasone is administered on epcoritamab treatment days and the following day. In Cycle 6, both R-CHOP and epcoritamab are given on Day 1 only. This is followed by two 28-day consolidation cycles (Cycles 7-8) with epcoritamab on Day 1. Safety follow-up occurs at Week 8 and every 3 months for up to one year. Participants who discontinue due to adverse events will be followed until improvement or stabilization, or until new therapy begins, whichever occurs first.
Participants will receive 8 cycles of rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) chemotherapy combined with epcoritamab. A standard dose of dexamethasone is given in Cycle 2. Treatment includes six 21-day cycles: Cycle 1 consists of R-CHOP alone; Cycles 2-5 include R-CHOP on Day 1 with epcoritamab on Days 1, 8, and 15. In Cycle 2, dexamethasone is given on epcoritamab treatment days and for 3 subsequent days. In Cycle 6, both R-CHOP and epcoritamab are given on Day 1 only. This is followed by two 28-day consolidation cycles (Cycles 7-8) with epcoritamab on Day 1. Safety follow-up occurs at Week 8 and every 3 months for up to one year. Participants who discontinue due to adverse events will be followed until improvement or stabilization, or until new therapy begins, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mwanasha Merrill, MD
Lead Sponsor
Citations
1.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/64/548791/Epcoritamab-R-mini-CHOP-results-in-2-yearEpcoritamab + R-mini-CHOP results in 2-year remissions and ...
However, outcomes following R-mini-CHOP remain suboptimal, with overall response rates (ORR) of 60%–80%, complete response (CR) rates of 40%–60% ...
Study Details | NCT04663347 | Safety and Efficacy Trial of ...
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, ...
3.
onclive.com
onclive.com/view/fixed-duration-epcoritamab-plus-r-chop-provides-durable-remissions-in-first-line-dlbclFixed-Duration Epcoritamab Plus R-CHOP Provides ...
Epcoritamab-bysp combined with R-CHOP achieved a 98% objective response rate in newly diagnosed DLBCL, with sustained remissions beyond three ...
Fixed-duration epcoritamab plus R2 drives favorable ... - PMC
In the phase 3 AUGMENT trial, R2 resulted in an overall response rate (ORR) of 78% and complete response (CR) rate of 34% in patients with R/R FL or marginal ...
5.
ir.genmab.com
ir.genmab.com/news-releases/news-release-details/genmab-announces-epcoritamab-investigational-combination-therapyGenmab Announces Epcoritamab Investigational ...
At six months, an estimated 81 percent of responses were ongoing, 74 percent of patients were progression free, and 100 percent of patients were ...
581 Fixed-Duration Epcoritamab + R-CHOP Induces High ...
The combination of epcoritamab + R‐CHOP showed encouraging response rates and a manageable safety profile in 1L DLBCL, including in high-risk patients.
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