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Monoclonal Antibodies

EZR for Follicular Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Reid Merryman, MD

Eligibility Criteria Checklist

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

Must have

Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) at time of trial entry with review of the diagnostic pathology specimen at participating institutions (patients with current histologic transformation are excluded)

Receipt of at least one prior line of therapy for FL including both a CD20 monoclonal antibody and an alkylating agent

Must not have

Bulky cervical adenopathy compressing upper airway

Presence of HBsAg or HBcAb without undetectable HBV DNA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to investigate the effectiveness and safety of using a combination of epcoritamab, zanubrutinib, and rituximab to treat individuals with relapsed or

Who is the study for?

This trial is for individuals with Follicular Lymphoma that has returned or hasn't responded to previous treatments. Participants should meet specific health criteria set by the study, but these details are not provided here.

What is being tested?

The trial tests a combination of three drugs: Epcoritamab (antibody), Zanubrutinib (Bruton tyrosine kinase inhibitor), and Rituximab (monoclonal antibody) to see how effective and safe they are in treating relapsed or refractory Follicular Lymphoma.

What are the potential side effects?

Potential side effects may include reactions related to the immune system, bleeding issues due to blood thinning, infections because of lowered immunity, infusion-related reactions, and possibly others not listed here.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of non-Hodgkin lymphoma known as CD20+ follicular lymphoma, grades 1-3A.

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I have received treatment for follicular lymphoma that included a CD20 antibody and an alkylating agent.

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My cancer can be measured on scans and shows up on PET, CT, or MRI.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Exclusion Criteria

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

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I have large neck lymph nodes affecting my breathing.

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I have hepatitis B surface antigen or core antibody with detectable virus DNA.

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I do not have recent heart attacks, heart failure, or serious irregular heartbeats.

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I have a history of hemophagocytic lymphohistiocytosis.

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I cannot tolerate anti-CD20 therapy or am allergic to epcoritamab.

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I have been treated with a BTK inhibitor before.

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I have not had major surgery or a serious injury in the last 4 weeks.

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I am currently on medication for an active infection.

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I currently have an active COVID-19 infection.

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I have had a solid organ or bone marrow transplant.

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My cancer has spread to my brain or spinal cord.

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My neuropathy is mild or not present.

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I have recently undergone CAR-T therapy.

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I haven't taken any experimental drugs or chemotherapy recently.

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I am not taking warfarin or strong drugs that affect liver enzyme activity.

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I have a severe bleeding disorder or am currently on warfarin.

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I have had major surgery recently or will have it during the study.

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I cannot swallow pills or have major stomach/intestine problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 Metabolic Response (CMR) Rate

Secondary study objectives

2-Year Progression Free Survival (PFS2)

Cytokine Release Syndrome (CRS) Rate

Duration of Complete Response (DOCR)

+13 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: Rituxam + Zanubrutinib + EpcoritamabExperimental Treatment3 Interventions

Enrolled participants will complete: * Baseline visit with imaging and bone marrow biopsy * Imaging on cycles 3, 6, 9, 13, and 19 * Up to 2 years of treatment with study drugs * End of Treatment visit with imaging and bone marrow biopsy * Follow up visits every 6 months for up to 10 years

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zanubrutinib

2017

Completed Phase 3

~2160

Rituximab

1999

Completed Phase 4

~2990