What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as the R-CHOP regimen, have known side effects including hair loss, nausea, vomiting, fatigue, increased risk of infections, and potential cardiotoxicity. Rituximab, a B-cell targeting monoclonal antibody used in R-CHOP, can cause infusion-related reactions, fever, chills, and low blood cell counts. Epcoritamab, an investigational B-cell targeting drug, may have similar side effects, including immune-related adverse events.

What prior FDA approvals exist?

FDA-approved treatments for Non-Hodgkin's Lymphoma that target and kill B-cells include Rituximab, Obinutuzumab, and Ofatumumab, all of which target the CD20 antigen on B-cells. Additionally, CAR T-cell therapies such as Axicabtagene Ciloleucel and Tisagenlecleucel, which target CD19 on B-cells, have also been approved. These therapies are similar to Epcoritamab, an investigational drug being studied for its efficacy in targeting and killing B-cells in Diffuse Large B-Cell Lymphoma (DLBCL).

What other types of research exist?

Promising novel alternatives to Epcoritamab for Non-Hodgkin's Lymphoma patients include: 1) CAR T-cell therapies such as Axicabtagene Ciloleucel (Yescarta) and Tisagenlecleucel (Kymriah), which have shown significant efficacy in relapsed or refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like Blinatumomab, which target CD19 on B-cells and have demonstrated promising results in clinical trials. 3) Antibody-drug conjugates (ADCs) such as Polatuzumab Vedotin, which targets CD79b and has been approved for use in combination with other therapies for relapsed or refractory DLBCL.

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Alkylating agents

Epcoritamab + R-CHOP for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-2 Trial)

Phase 3

Recruiting

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 76 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a new drug called epcoritamab combined with a mix of cancer-fighting drugs in adults with a rare type of aggressive cancer called DLBCL. Epcoritamab helps the immune system attack cancer cells, while the other drugs work together to kill them. This combination has been used as the standard treatment for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) for many years.

Who is the study for?

Adults with newly diagnosed CD20+ diffuse large B-cell lymphoma (DLBCL) who have not had prior systemic anti-lymphoma therapy, except certain steroids or vincristine for pre-treatment. Participants must have a specific level of disease severity (IPI score 2-5), be able to perform daily activities (ECOG score 0-2), and meet certain health criteria including heart function and measurable lesions.

What is being tested?

The trial is testing the effectiveness of Epcoritamab combined with R-CHOP chemotherapy compared to standard R-CHOP alone in treating DLBCL. Patients are randomly assigned to one of two groups: one receiving subcutaneous Epcoritamab plus R-CHOP, the other receiving just R-CHOP followed by Rituximab, both in cycles lasting 21 days.

What are the potential side effects?

Potential side effects include reactions at the injection site for Epcoritamab, as well as common chemotherapy-related side effects such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential heart issues from Doxorubicin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 76 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 76 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 76 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5

Secondary study objectives

Number of Participants with Event-free survival (EFS)

Number of Participants with PFS

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: R-CHOP and RituximabExperimental Treatment5 Interventions

Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.

Group II: Epcoritamab and R-CHOPExperimental Treatment6 Interventions

Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Vincristine

2003

Completed Phase 4

~2970

Cyclophosphamide

2010

Completed Phase 4

~2310

Doxorubicin

2012

Completed Phase 3

~8030

Rituximab

1999

Completed Phase 4

~2990

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include targeted therapies and combination chemotherapy regimens. Epcoritamab, a bispecific antibody, targets CD3 on T-cells and CD20 on B-cells, leading to the direct killing of malignant B-cells. This is crucial for NHL patients as it specifically eliminates the cancerous cells. Similarly, the R-CHOP regimen combines Rituximab (targets CD20), Cyclophosphamide (damages DNA), Doxorubicin (intercalates DNA), Vincristine (inhibits microtubules), and Prednisone (reduces inflammation). These treatments work together to kill cancer cells, reduce tumor burden, and improve patient outcomes.