← Back to Search

Monoclonal Antibodies

Arm B: Chemoimmunotherapy (CIT) Option A for Follicular Lymphoma (EPCORE™FL-2 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

Stage III or IV disease, or stage II with bulky disease (tumor diameter of >=7 cm)

ECOG performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

EPCORE™FL-2 Trial Summary

This trial will test the effectiveness and safety of a new drug called epcoritamab, in combination with lenalidomide and rituximab, for treating patients with follicular

Who is the study for?

Adults with previously untreated Follicular Lymphoma (FL) who need systemic treatment and meet specific medical criteria, including a certain stage of disease and tumor size. They must be able to follow the study procedures and have an acceptable performance status for daily activities.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of Epcoritamab combined with Rituximab and Lenalidomide in treating FL. Participants are divided into groups receiving different treatments, including standard chemoimmunotherapy options, over a period of 120 weeks.See study design

What are the potential side effects?

Potential side effects may include reactions at injection sites, increased risk of infections due to immune system suppression, fatigue, nausea from chemotherapy drugs, as well as possible blood disorders or organ inflammation.

EPCORE™FL-2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is advanced or my tumor is large (>=7 cm).

Select...

I can take care of myself and am up and about more than half of the day.

Select...

I have been diagnosed with follicular lymphoma.

Select...

I have at least one cancer lesion that shows up on scans.

Select...

My biopsy shows I have classic Follicular Lymphoma.

EPCORE™FL-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

Secondary outcome measures

Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Change (PGIC)

Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Severity (PGIS)

Arm A vs Arm B: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]

+49 more

EPCORE™FL-2 Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm C: Lenalidomide and Rituximab (R2)Experimental Treatment2 Interventions

Participants will receive lenalidomide and rituximab (R2) during the 120 week study duration.

Group II: Arm B: Chemoimmunotherapy (CIT) Option BExperimental Treatment4 Interventions

Participants will receive CIT Option B (G and bendamustine (Benda) [G-Benda]/R-Benda during the 120 week study duration.

Group III: Arm B: Chemoimmunotherapy (CIT) Option AExperimental Treatment6 Interventions

Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) [G-CHOP]/ rituximab (R)-CHOP during the 120 week study duration.

Group IV: Arm A: Epcoritamab + Lenalidomide and Rituximab (R2)Experimental Treatment3 Interventions

Participants will receive epcoritamab in combination with R2 during the 120 week study duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Bendamustine

2015

Completed Phase 3

~2950

Vincristine

2003

Completed Phase 4

~2910

Obinutuzumab

2015

Completed Phase 3

~3250

Rituximab

1999

Completed Phase 4

~1880

Cyclophosphamide

1995

Completed Phase 3

~3770

Doxorubicin

2012

Completed Phase 3

~7940

Lenalidomide

2005

Completed Phase 3

~1480

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

501,490 Total Patients Enrolled

GenmabIndustry Sponsor

56 Previous Clinical Trials

11,332 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,209 Total Patients Enrolled

Frequently Asked Questions

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

Are potential participants currently able to apply for enrollment in this trial?

"Affirmative. As per clinicaltrials.gov, this research endeavor is currently seeking suitable participants. The study was first listed on February 5th, 2024 and most recently revised on the same date. A total of 900 individuals are sought for enrollment from five designated locations."

Answered by AI

In how many distinct locations is this investigation currently being conducted?

"The trial is being conducted at St. Luke's Hospital - Chesterfield /ID# 260489 in Chesterfield, Missouri; Mission Cancer and Blood /ID# 262132 in Des Moines, Iowa; and American Oncology Partners of Maryland, PA /ID# 259476 in Bethesda, Maryland alongside five additional locations."

Answered by AI

Has the combination of Epcoritamab with Lenalidomide and Rituximab (R2) in Arm A received approval from the Food and Drug Administration?

"Our assessment at Power indicates a safety rating of 3 for Arm A: Epcoritamab + Lenalidomide and Rituximab (R2) due to the accumulation of evidence supporting its efficacy and safety throughout this Phase 3 trial."

Answered by AI

What is the upper limit for the total number of individuals involved in this medical study?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is actively seeking individuals. The study was initially published on February 5th, 2024, with the latest revision also occurring on the same date. In total, 900 participants are sought from five distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

2024. "Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191744.

All > Paid Studies Seattle > Follicular Lymphoma