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Monoclonal Antibodies
Epcoritamab + R2 for Follicular Lymphoma (EPCORE FL-1 Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report
Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years from randomization
Awards & highlights
EPCORE FL-1 Trial Summary
This trial will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) Follicular Lymphoma (FL).
Who is the study for?
Adults with relapsed or refractory Follicular Lymphoma who've had prior treatments including an anti-CD20 monoclonal antibody can join. They need a positive PET scan showing the disease and at least one measurable lesion. Participants should be able to perform daily activities (ECOG score 0-2) and have not been treated with lenalidomide in the past year.Check my eligibility
What is being tested?
The trial is testing Epcoritamab combined with Rituximab and Lenalidomide (R2) for safety and effectiveness against Follicular Lymphoma. Patients are divided into groups receiving different treatments, including R2 alone or with Epcoritamab, over multiple cycles lasting 28 days each.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, infusion-related symptoms, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues like nausea or diarrhea, and potential allergic responses.
EPCORE FL-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is confirmed to be of a type that has not become more aggressive and tests positive for CD20.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My scans show a tumor that can be measured and matches PET scan results.
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My condition worsened or didn't improve after treatment with an anti-CD20 drug and chemotherapy.
EPCORE FL-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years from randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years from randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Overall Survival (OS)
Percentage of Participants Achieving Complete Response (CR)
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
EPCORE FL-1 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Epcoritamab Dose B in Combination With R2Experimental Treatment3 Interventions
Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
Group II: Epcoritamab Dose A in Combination With R2Experimental Treatment3 Interventions
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Group III: Lenalidomide and Rituximab (R2)Active Control2 Interventions
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
501,895 Total Patients Enrolled
GenmabIndustry Sponsor
56 Previous Clinical Trials
11,732 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,609 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with lenalidomide in the last 12 months.My doctor has approved me for R2 treatment.My lymphoma is confirmed to be of a type that has not become more aggressive and tests positive for CD20.My condition did not improve with lenalidomide treatment.I can take care of myself and am up and about more than half of my waking hours.My scans show a tumor that can be measured and matches PET scan results.My condition worsened or didn't improve after treatment with an anti-CD20 drug and chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Epcoritamab Dose B in Combination With R2
- Group 2: Epcoritamab Dose A in Combination With R2
- Group 3: Lenalidomide and Rituximab (R2)
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there short-term or long-term risks to patients associated with Epcoritamab?
"There is some evidence from earlier phases of testing to support the safety of Epcoritamab, so it received a score of 3."
Answered by AI
How large is the candidate pool for this research project?
"In order to properly carry out the study, 642 patients that meet the requirements need to be found. The sponsor, Genmab, will be running the trial from various locations, two of which are Victoria Hospital in London, Ontario /ID# 229409 and CSSS Alphonse-Desjardins, CHAU de Levis in Levis, Quebec /ID# 229896."
Answered by AI
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