A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510965-41-00

Acronym

M22-128

Enrollment

116

Registered

2024-08-19

Start date

2024-09-03

Completion date

Unknown

Last updated

2025-12-15

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

Conditions

Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Brief summary

Progression-free survival (PFS)

Detailed description

Percentage of Participants Who Achieve Complete response (CR), Overall Survival (OS), Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate

Interventions

DRUGGemcitabine 38 mg/ml Concentrate for Solution for Infusion

DRUGRevlimid 25 mg hard capsules

DRUGEpcoritamab (GEN3013)

DRUGOxaliplatin 5mg/ml Concentrate for Solution for Infusion

DRUGRevlimid 5 mg hard capsules

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGRevlimid 20 mg hard capsules

DRUGTruxima 100 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Percentage of Participants Who Achieve Complete response (CR), Overall Survival (OS), Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate	—

Countries

Belgium, Bulgaria, Croatia, Czechia, France, Greece, Hungary, Netherlands, Poland, Portugal, Romania

Outcome results

None listed

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