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No longer recruiting (closed or complete)Last updated: 11 May 2026

EPCORE DLBCL-4: This trial is comparing how safe and effective two combination treatments (E-Len vs. R-GemOx) are in treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

EPCORE DLBCL-4

Clinical summary

Summary

The study is recruiting people with confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL), who have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.

Eligible participants will be randomly allocated to one of two groups, called treatment arms. Each treatment arm will receive a different treatment. Treatment cycles in both arms are 28 days.

Participants in Arm A will receive E-Len treatment. This consists of subcutaenous (SC) injections of epcoritamab immunotherapy, plus oral lenalidomide capsules for up to 12 cycles.

Participants in Arm B will receive R-GemOx treatment. This consists of rituximab targeted therapy, plus oxaliplatin and gemcitabine chemotherapy, all administered as intravenous (IV) infusions, for up to 4 cycles.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

This trial is treating people with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group Performance status score of 0 to 2.
  • Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
  • Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.

  • . Participant must meet at least 1 of the following criteria:

    • Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to ASCT.
    • Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.

    • Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

      • Unable to receive CAR-T therapy due to fitness and/or comorbidity.
      • Lymphocyte apheresis failure.
      • Unwilling to receive CAR-T therapy.
      • Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
      • Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
  • Must have measurable disease.
  • Life expectancy > 3 months on standard of care treatment at the time of enrolling in the study

Exclusion

  • Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
  • History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
  • Documented refractoriness to lenalidomide.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Genmab

Scientific Title

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

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