A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506906-38-00

Acronym

M22-003

Enrollment

357

Registered

2024-04-29

Start date

2024-05-23

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Brief summary

The primary endpoint is the Complete Response rate at 30 months/120 weeks (CR30) in Arm A1 (ER2) versus Arm B (CIT), as determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

Detailed description

OS, MRD negativity rate, PROs: Change from baseline in physical functioning (assessed by the physical functioning scale of the EORTC QLQ-C30) at Week 21 for Arm A1 and Week 21 (G/R-Benda regimen)/22 (G/R-CHOP regimen) for Arm B.

Interventions

DRUGBendamustine 100 mg Powder for concentrate for Solution for Infusion

DRUGTruxima 100 mg concentrate for solution for infusion

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGPREDNISONE BIOGARAN 20 mg

DRUGscored tablet

DRUGCyclophosphamide Injection 500 mg.

DRUGDoxorubicin 2 mg/ml Solution for Injection.

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGVincristine Sulfate 1 mg/ml solution for injection

DRUGRevlimid 5 mg hard capsules

DRUGEpcoritamab (GEN3013)

DRUGRevlimid 20 mg hard capsules

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the Complete Response rate at 30 months/120 weeks (CR30) in Arm A1 (ER2) versus Arm B (CIT), as determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.	—

Secondary

Measure	Time frame
OS, MRD negativity rate, PROs: Change from baseline in physical functioning (assessed by the physical functioning scale of the EORTC QLQ-C30) at Week 21 for Arm A1 and Week 21 (G/R-Benda regimen)/22 (G/R-CHOP regimen) for Arm B.	—

Countries

Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026