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Monoclonal Antibodies

Epcoritamab +/- Lenalidomide for Non-Hodgkin's Lymphoma (EPCORE DLBCL-3 Trial)

Phase 2
Recruiting
Research Sponsored by Genmab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to being age ≥80 years or age ≥75 years with important comorbid condition(s)
Must have newly diagnosed CD20+ large cell lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years
Awards & highlights

EPCORE DLBCL-3 Trial Summary

This trial will test a new antibody and a drug for elderly patients with DLBCL who can't take other medicines. All patients will get active treatment.

Who is the study for?
This trial is for elderly patients (≥75 years old with comorbidities or ≥80 years) newly diagnosed with CD20+ large cell lymphoma who can't handle standard anthracycline therapy. They should have a certain level of physical fitness (ECOG PS ≤2), measurable disease, and good organ function. Exclusions include major surgery within the last month, CNS tumors, active infections like hepatitis B/C or COVID-19, severe heart conditions, recent live vaccines, HIV positivity, other cancers or seizure disorders.Check my eligibility
What is being tested?
The study tests epcoritamab alone or combined with lenalidomide in treating Diffuse Large B-Cell Lymphoma in those unfit for anthracycline therapy. All participants receive treatment; they're randomly assigned to one of the two groups to compare effectiveness and safety.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs used, increased risk of infection due to immune system suppression by lenalidomide and possible cytokine release syndrome from epcoritamab which can cause fever and flu-like symptoms.

EPCORE DLBCL-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 75 with health issues or over 80, making me ineligible for certain cancer treatments.
Select...
I have been recently diagnosed with a type of lymphoma that tests positive for CD20.
Select...
My cancer is at stage II, III, or IV according to the Ann Arbor classification.

EPCORE DLBCL-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) rate
Secondary outcome measures
Assess pharmacokinetics (PK) of epcoritamab
Duration of complete response (DOCR)
Duration of response (DOR)
+10 more

EPCORE DLBCL-3 Trial Design

2Treatment groups
Experimental Treatment
Group I: Epcoritamab monotherapyExperimental Treatment1 Intervention
Group II: Epcoritamab in combination with lenalidomideExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor
56 Previous Clinical Trials
12,052 Total Patients Enrolled
AbbVieIndustry Sponsor
950 Previous Clinical Trials
496,748 Total Patients Enrolled

Media Library

Epcoritamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05660967 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Epcoritamab monotherapy, Epcoritamab in combination with lenalidomide
Non-Hodgkin's Lymphoma Clinical Trial 2023: Epcoritamab Highlights & Side Effects. Trial Name: NCT05660967 — Phase 2
Epcoritamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660967 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are actively engaging in this experiment?

"There are 36 medical sites partaking in this research project, including GZA Ziekenhuizen in Antwerp, Institut Jules Bordet in Brussel, and Universitair Ziekenhuis Brussel located nearby Leuven. Additionally, there are several other locales involved as well."

Answered by AI

Is the enrollment period for this research study still open?

"Per the data present on clinicaltrials.gov, this research project is currently recruiting participants. It was first listed on March 1st 2023 and has received an update as recently as March 3rd of the same year."

Answered by AI

Has the FDA greenlit Epcoritamab as a solo treatment option?

"With Phase 2 data supporting its safety, our team at Power assigned Epcoritamab monotherapy a score of 2. Unfortunately, there is no evidence demonstrating efficacy yet."

Answered by AI

How many participants are participating in this medical study?

"Affirmative. According to clinicaltrials.gov, this medical experiment posted on March 1st 2023 and recently updated on the 3rd of March is actively recruiting patients for participation. 180 individuals are being sought from 36 different institutions."

Answered by AI
~86 spots leftby Mar 2025