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Monoclonal Antibodies

Rituxam + Zanubrutinib + Epcoritamab 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 one of the participating institutions. Patients with current histologic transformation are excluded.
* Receipt of at least one prior line of therapy for FL (with prior treatment including both a CD20 monoclonal antibody and an alkylating agent).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 years
Awards & highlights

Summary

The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL). * The names of the study drugs involved in this research study are: * Epcoritamab (a type of antibody) * Zanubrutinib (a type of Bruton tyrosine kinase inhibitor) * Rituximab (a type of monoclonal antibody)

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

Timeline

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

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
~1940
Rituximab
1999
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

BeiGeneIndustry Sponsor
185 Previous Clinical Trials
29,462 Total Patients Enrolled
GenmabIndustry Sponsor
62 Previous Clinical Trials
12,676 Total Patients Enrolled
Reid Merryman, MDLead Sponsor
2 Previous Clinical Trials
85 Total Patients Enrolled
~16 spots leftby Mar 2027
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