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Monoclonal Antibodies

Epcoritamab for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Gottfried Von Keudell, MD, PhD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

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

Must have

Stage III/IV at initial diagnosis

Completed all prior anti-lymphoma therapy at least 4 weeks prior to start of epcoritamab

Must not have

Uncontrolled neurologic conditions

Uncontrolled active infection requiring hospitalization within 4 weeks of treatment start

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a drug called epcoritamab is helpful in treating follicular lymphoma as a second treatment option. The study drug being used is epcoritamab

Who is the study for?

This trial is for adults with follicular lymphoma who didn't fully respond to initial treatment. They should have a life expectancy over 2 years, good organ function, and no recent severe illnesses or drug abuse. Participants must not be pregnant, agree to use birth control, and have had only one prior therapy.

What is being tested?

The study tests Epcoritamab as a second-line treatment for follicular lymphoma. It's an antibody that targets the cancer cells. Patients will receive this medication to see if it can improve their condition after other treatments haven't led to complete remission.

What are the potential side effects?

Possible side effects of Epcoritamab may include allergic reactions similar to those seen with other antibodies, which could range from mild skin reactions to more serious conditions affecting different organs.

Eligibility Criteria

Inclusion Criteria

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

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My cancer was stage III or IV when first diagnosed.

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I finished my lymphoma treatment 4 weeks before starting epcoritamab.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have had one previous systemic treatment.

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My side effects from previous treatments have mostly gone away.

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My lymphoma is confirmed by biopsy and is CD20 positive.

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I have a lymph node that can be measured on scans.

Exclusion Criteria

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

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I have a neurological condition that is not well-managed.

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I have not been hospitalized for an infection in the last 4 weeks.

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I have heart problems that are not well-managed.

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I have recently been on immunosuppressive therapy.

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My heart and lungs meet the study's health requirements.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Complete Response Rate (CRR)

Secondary study objectives

Grade 4-5 Treatment-related Toxicity Rate

Median Duration of Complete Response

Median Duration of Response (DOR)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: EpcoritamabExperimental Treatment1 Intervention

35 participants will be enrolled and will complete study procedures as follows: * Baseline visit with imaging (CT, MRI or PET scan) and bone marrow biopsy. * Imaging after Cycles 3 and 6 only. * Cycles 1-3: --Days 1, 8, 15 and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily * Cycles 4-9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily * Cycles 10-12: --Day 1 of 28 day cycles: Predetermined dose of Epcoritamab 1x daily * End of Treatment visit with imaging and bone marrow biopsy. * Follow up: every 3 months for 2 years or until disease worsens. * Off study visit with imaging.

0 / 14Eligibility criteria met