OncoMatch/Clinical Trials/NCT06508658
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Is NCT06508658 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for diffuse large b-cell lymphoma.
Treatment: Epcoritamab · Rituximab · Lenalidomide · Oxaliplatin · Gemcitabine — B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world. Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 overexpression (CD20+)
Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody-containing combination chemotherapy — since DLBCL diagnosis
previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis
Cannot have received: bispecific antibody targeting CD3 and CD20
History of prior treatment with a bispecific antibody targeting CD3 and CD20
Cannot have received: rituximab plus gemcitabine and oxaliplatin (rituximab, gemcitabine, oxaliplatin)
prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx)
Cannot have received: gemcitabine and oxaliplatin (gemcitabine, oxaliplatin)
prior treatment with...gemcitabine and oxaliplatin (GemOx)
Cannot have received: immunomodulatory agent (lenalidomide)
Exception: documented refractoriness
Documented refractoriness to lenalidomide
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center /ID# 273338 · Duarte, California
- Valkyrie Clinical Trials /ID# 269935 · Los Angeles, California
- Desert Regional Medical Center /ID# 272437 · Palm Springs, California
- Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823 · Golden, Colorado
- City Of Hope - Atlanta. /ID# 273092 · Newnan, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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