What side effects are associated with this type of intervention?

Common treatments for Follicular Lymphoma, such as Rituximab and Lenalidomide, have known side effects. Rituximab can cause infusion reactions, infections, and cytopenias. Lenalidomide is associated with neutropenia, thrombocytopenia, fatigue, and an increased risk of venous thromboembolism. Epcoritamab, a bispecific antibody targeting CD3 and CD20, may cause cytokine release syndrome, infections, and cytopenias.

What prior FDA approvals exist?

The FDA has approved several CD20-targeting therapies for the treatment of Follicular Lymphoma. Rituximab, a monoclonal antibody targeting CD20, has been widely used and is often combined with chemotherapy. Other CD20-targeting monoclonal antibodies include Obinutuzumab and Ofatumumab. Additionally, bispecific antibodies like Mosunetuzumab, which targets CD20 on B cells and CD3 on T cells, have shown promise in clinical trials for relapsed or refractory Follicular Lymphoma, similar to the investigational drug Epcoritamab.

What other types of research exist?

Promising novel alternatives to Epcoritamab for Follicular Lymphoma patients include: <ol> <li>Blinatumomab: A bispecific T-cell engager (BiTE) targeting CD19 on B cells and CD3 on T cells, showing efficacy in B-cell malignancies.</li> <li></li> </ol> Polatuzumab vedotin: An antibody-drug conjugate targeting CD79b, combined with rituximab and bendamustine, has shown promising results in relapsed/refractory FL. 3. Mosunetuzumab: A bispecific antibody targeting CD20 and CD3, currently under investigation for its efficacy in FL. 4. Lenalidomide plus Rituximab (R2 regimen): This combination has been effective in treating relapsed/refractory FL and is a well-established regimen.

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Monoclonal Antibodies

Epcoritamab + R2 for Follicular Lymphoma (EPCORE FL-1 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

Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report

Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2

Must not have

Documented refractoriness to lenalidomide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 8 years from randomization

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug combination to treat adults with a type of cancer called follicular lymphoma that has returned or resisted other treatments. The new drug, epcoritamab, is used with lenalidomide and rituximab to help the immune system fight the cancer. The study will check how safe and effective this treatment is.

Who is the study for?

Adults with relapsed or refractory Follicular Lymphoma who've had prior treatments including an anti-CD20 monoclonal antibody can join. They need a positive PET scan showing the disease and at least one measurable lesion. Participants should be able to perform daily activities (ECOG score 0-2) and have not been treated with lenalidomide in the past year.

What is being tested?

The trial is testing Epcoritamab combined with Rituximab and Lenalidomide (R2) for safety and effectiveness against Follicular Lymphoma. Patients are divided into groups receiving different treatments, including R2 alone or with Epcoritamab, over multiple cycles lasting 28 days each.

What are the potential side effects?

Possible side effects include reactions at injection sites, infusion-related symptoms, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues like nausea or diarrhea, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is confirmed to be of a type that has not become more aggressive and tests positive for CD20.

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I can take care of myself and am up and about more than half of my waking hours.

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My scans show a tumor that can be measured and matches PET scan results.

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My condition worsened or didn't improve after treatment with an anti-CD20 drug and chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition did not improve with lenalidomide treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 8 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 8 years from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 years from randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

Overall Survival (OS)

Percentage of Participants Achieving Complete Response (CR)

Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

3Treatment groups

Experimental Treatment

Active Control

Group I: Epcoritamab Dose B in Combination With R2Experimental Treatment3 Interventions

Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.

Group II: Epcoritamab Dose A in Combination With R2Experimental Treatment3 Interventions

Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).

Group III: Lenalidomide and Rituximab (R2)Active Control2 Interventions

Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Lenalidomide

FDA approved

0 / 5Eligibility criteria met

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 Follicular Lymphoma include rituximab, lenalidomide, and investigational drugs like epcoritamab. Rituximab targets CD20 on B cells, leading to their destruction. Lenalidomide enhances the immune system's ability to attack cancer cells and inhibits angiogenesis. Epcoritamab, a bispecific antibody, targets CD3 on T cells and CD20 on B cells, facilitating the destruction of B cells by bringing T cells into close proximity. These targeted mechanisms are crucial for Follicular Lymphoma patients as they aim to eliminate malignant B cells while minimizing damage to normal cells.