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
Public ClinicalTrials.gov record NCT06508658. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06508658
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 379 participants
Conditions and interventions
Conditions
Interventions
- Epcoritamab Drug
- Rituximab Drug
- Lenalidomide Drug
- Oxaliplatin Drug
- Gemcitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 12, 2024
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
- Last update posted
- Apr 7, 2026
2024 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center /ID# 273338 | Duarte | California | 91010 | — |
| Valkyrie Clinical Trials /ID# 269935 | Los Angeles | California | 90067 | — |
| Desert Regional Medical Center /ID# 272437 | Palm Springs | California | 92262 | — |
| Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823 | Golden | Colorado | 80401 | — |
| City Of Hope - Atlanta. /ID# 273092 | Newnan | Georgia | 30265 | — |
| Rush University Medical Center /ID# 242103 | Chicago | Illinois | 60612 | — |
| City Of Hope - Chicago /ID# 274430 | Zion | Illinois | 60099 | — |
| Northwest Cancer Center - Dyer Clinic /ID# 269787 | Dyer | Indiana | 46311 | — |
| Cancer Center of Kansas - Wichita /ID# 270117 | Wichita | Kansas | 67214 | — |
| University of Kentucky Chandler Medical Center. /ID# 242087 | Lexington | Kentucky | 40536 | — |
| University of Maryland, Baltimore /ID# 242216 | Baltimore | Maryland | 21201 | — |
| Henry Ford Hospital /ID# 266446 | Detroit | Michigan | 48202 | — |
| Gulfport Memorial Hospital /ID# 268104 | Gulfport | Mississippi | 39501 | — |
| New York Medical College /ID# 265799 | Valhalla | New York | 10595 | — |
| East Carolina University - Brody School of Medicine /ID# 242227 | Greenville | North Carolina | 27834 | — |
| Thompson Cancer Survival Ctr /ID# 242149 | Knoxville | Tennessee | 37916 | — |
| Community Cancer Trials Of Utah /ID# 271715 | Ogden | Utah | 84405 | — |
| Utah Cancer Specialists - Salt Lake City /ID# 268603 | Salt Lake City | Utah | 84106 | — |
| Veterans Affairs Medical Center - Salt Lake City /ID# 265329 | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 157 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06508658, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06508658 live on ClinicalTrials.gov.