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Chemotherapy

Epcoritamab Combinations for Non-Hodgkin's Lymphoma (EPCORE™ NHL-2 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Genmab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

EPCORE™ NHL-2 Trial Summary

This trial is testing a new drug, epcoritamab, to see if it is safe and effective in treating B-cell Non-Hodgkin Lymphoma.

Who is the study for?
This trial is for adults with B-cell Non-Hodgkin Lymphoma who are in relatively good health (ECOG PS score of 0-2), have measurable disease, and proper organ function. They must not have had certain treatments like bispecific antibodies or CAR-T therapy recently, no active infections like TB or hepatitis, and no history of HIV. Participants should use effective birth control.Check my eligibility
What is being tested?
The trial tests Epcoritamab combined with standard cancer drugs in people with B-NHL. It's an early-stage multinational study to check the safety, how the body processes it, immune response, and initial effectiveness against lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to Epcoritamab and other chemotherapy agents such as fatigue, nausea, risk of infection, blood cell count changes; specific side effects will depend on the drug combinations used.

EPCORE™ NHL-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lymphoma is CD20-positive.
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I am a man willing to use contraception if my partner can have children.
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I have at least one tumor that can be measured on a scan.
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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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My organs are functioning well.

EPCORE™ NHL-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, 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
Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs)
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
Part 2 (Except Arm 7): Overall Response Rate (ORR)
Secondary outcome measures
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
+23 more

EPCORE™ NHL-2 Trial Design

10Treatment groups
Experimental Treatment
Group I: Arm 9 - Epcoritamab + LenalidomideExperimental Treatment2 Interventions
In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
Group II: Arm 8 - Epcoritamab + R mini-CHOPExperimental Treatment2 Interventions
In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
Group III: Arm 7 - Epcoritamab maintenanceExperimental Treatment1 Intervention
In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
Group IV: Arm 6 - Epcoritamab + R2Experimental Treatment2 Interventions
In participants with previously untreated FL.
Group V: Arm 5 - Epcoritamab + GemOxExperimental Treatment2 Interventions
In participants with R/R DLBCL ineligible ASCT.
Group VI: Arm 4 - Epcoritamab + R-DHAX/CExperimental Treatment2 Interventions
In participants with R/R DLBCL eligible for ASCT.
Group VII: Arm 3 - Epcoritamab + BRExperimental Treatment2 Interventions
In participants with previously untreated FL.
Group VIII: Arm 2 - Epcoritamab + R2Experimental Treatment2 Interventions
In participants with R/R FL.
Group IX: Arm 10 - Epcoritamab + R-ICEExperimental Treatment2 Interventions
In participants with R/R DLBCL eligible for ASCT.
Group X: Arm 1 - Epcoritamab + R-CHOPExperimental Treatment2 Interventions
In participants with previously untreated DLBCL.
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
11,570 Total Patients Enrolled
AbbVieIndustry Sponsor
950 Previous Clinical Trials
496,266 Total Patients Enrolled

Media Library

Bendamustine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04663347 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Arm 9 - Epcoritamab + Lenalidomide, Arm 10 - Epcoritamab + R-ICE, Arm 1 - Epcoritamab + R-CHOP, Arm 2 - Epcoritamab + R2, Arm 3 - Epcoritamab + BR, Arm 4 - Epcoritamab + R-DHAX/C, Arm 5 - Epcoritamab + GemOx, Arm 6 - Epcoritamab + R2, Arm 7 - Epcoritamab maintenance, Arm 8 - Epcoritamab + R mini-CHOP
Non-Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT04663347 — Phase 1 & 2
Bendamustine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04663347 — Phase 1 & 2

Frequently Asked Questions

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

How many participants have been recruited for this clinical trial?

"The AbbVie-sponsored study requires 396 qualified participants, and will be conducted at the John Theurer Cancer Center in Hackensack, New jersey as well as UMPC Hillman Cancer Center in Pittsburgh, Pennsylvania."

Answered by AI

Are there still vacancies in this clinical trial?

"According to clinicaltrials.gov, the current state of affairs shows that this trial is actively seeking participants; it was first posted on November 16th 2020 and edited most recently on April 13th 2022."

Answered by AI

How many centers are conducting this research trial?

"Patients interested in participating can find locations for this clinical trial at the John Theurer Cancer Center, Hackensack UMC (Hackensack NJ), UMPC Hillman Cancer Center cancer Pavillion (Pittsburgh pa) and Dana Farber Cancer Institute (Boston ma). 10 other sites are also available."

Answered by AI

What medical conditions are commonly addressed with rituximab and lenalidomide?

"Rituximab and lenalidomide are typically used to treat macular edema, as well as pheochromocytomas, ocular conditions, and ulcerative colitis."

Answered by AI

Are there any prior investigations that have combined rituximab and lenalidomide?

"Rituximab and lenalidomide were first studied at the NIH Clinical Centre on Rockville Pike back in 1993. To date, there have been 5624 studies that have concluded with 3255 presently ongoing; a substantial amount of these trials are taking place out of Hackensack, New jersey."

Answered by AI
~397 spots leftby Mar 2029