What side effects are associated with this type of intervention?

Common treatments for Follicular Lymphoma, such as Rituximab and Lenalidomide, can cause side effects including infusion reactions, cytopenias (low blood cell counts), fatigue, and gastrointestinal symptoms. Chemoimmunotherapy regimens like R-CHOP and G-CHOP may lead to additional side effects such as neuropathy, alopecia (hair loss), febrile neutropenia (fever with low white blood cell count), and cardiotoxicity. Epcoritamab, a bispecific antibody targeting CD3 on T cells and CD20 on B cells, is being studied for its efficacy and safety, with potential side effects including cytokine release syndrome and immune-related adverse events.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Follicular Lymphoma include several monoclonal antibodies targeting CD20, such as Rituximab, Obinutuzumab, and Ofatumumab. These drugs are often used in combination with chemotherapy regimens like CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or Bendamustine. Additionally, bispecific antibodies like Mosunetuzumab, which targets CD20 and CD3, have shown promise in clinical trials, similar to the investigational drug Epcoritamab.

What other types of research exist?

Promising novel alternatives to Epcoritamab for Follicular Lymphoma patients include: <ol> <li>Lenalidomide plus Rituximab (R2) - This combination has shown efficacy in treating FL and is being evaluated in various clinical trials.</li> <li></li> </ol> Obinutuzumab-based regimens - Obinutuzumab combined with chemotherapy agents like CHOP or Bendamustine has demonstrated effectiveness in FL. 3. CAR T-cell therapies - These are emerging as a potent option for relapsed or refractory FL. 4. Bispecific antibodies like Mosunetuzumab, which targets CD20 and CD3, similar to Epcoritamab, are also under investigation and showing promise.

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Monoclonal Antibodies

Epcoritamab + Rituximab + Lenalidomide for Lymphoma (EPCORE™FL-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

Stage III or IV disease, or stage II with bulky disease (tumor diameter of >=7 cm)

ECOG performance status 0-2

Must not have

Active cytomegalovirus (CMV) disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a new drug combination for adults with untreated follicular lymphoma, a type of blood cancer. The new treatment includes epcoritamab, lenalidomide, and rituximab, which work together to help the immune system attack cancer cells. The study will check how safe and effective this combination is. Lenalidomide combined with rituximab has shown high efficacy in both relapsed/refractory and untreated follicular lymphoma.

Who is the study for?

Adults with previously untreated Follicular Lymphoma (FL) who need systemic treatment and meet specific medical criteria, including a certain stage of disease and tumor size. They must be able to follow the study procedures and have an acceptable performance status for daily activities.

What is being tested?

The trial is testing the safety and effectiveness of Epcoritamab combined with Rituximab and Lenalidomide in treating FL. Participants are divided into groups receiving different treatments, including standard chemoimmunotherapy options, over a period of 120 weeks.

What are the potential side effects?

Potential side effects may include reactions at injection sites, increased risk of infections due to immune system suppression, fatigue, nausea from chemotherapy drugs, as well as possible blood disorders or organ inflammation.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced or my tumor is large (>=7 cm).

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I can take care of myself and am up and about more than half of the day.

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I have been diagnosed with follicular lymphoma.

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I have at least one cancer lesion that shows up on scans.

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My biopsy shows I have classic Follicular Lymphoma.

Exclusion Criteria

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

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I am currently suffering from an active CMV infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Arm A vs Arm B: Number of Participants with Progression-free survival (PFS)

Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

Secondary study objectives

Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Change (PGIC)

Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Severity (PGIS)

Arm A vs Arm B: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]

+48 more

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm C: Lenalidomide and Rituximab (R2)Experimental Treatment2 Interventions

Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.

Group II: Arm B: Chemoimmunotherapy (CIT) Option BExperimental Treatment4 Interventions

Participants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.

Group III: Arm B: Chemoimmunotherapy (CIT) Option AExperimental Treatment6 Interventions

Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.

Group IV: Arm A: Epcoritamab + Lenalidomide and Rituximab (R2)Experimental Treatment3 Interventions

Participants will receive epcoritamab in combination with R2 during the 120 week treatment duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Prednisone

2014

Completed Phase 4

~2500

Bendamustine

2015

Completed Phase 3

~3230

Doxorubicin

2012

Completed Phase 3

~8030

Cyclophosphamide

2010

Completed Phase 4

~2310

Rituximab

1999

Completed Phase 4

~2990

Vincristine

2003

Completed Phase 4

~2970

Obinutuzumab

2014

Completed Phase 3

~3470

0 / 6Eligibility 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

Common treatments for Follicular Lymphoma (FL) include Rituximab, Lenalidomide, and investigational drugs like Epcoritamab. Rituximab is an anti-CD20 monoclonal antibody that targets B cells for immune-mediated destruction. Lenalidomide modulates the immune system and has direct anti-tumor effects. Epcoritamab, a bispecific antibody, targets CD3 on T cells and CD20 on B cells, engaging T cells to kill malignant B cells. These treatments are vital for FL patients as they specifically target cancerous B cells, reducing tumor burden and potentially prolonging survival while minimizing harm to normal cells.