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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
NCT06508658 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Epcoritamab
- DRUG Oxaliplatin
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Gemcitabine
Study Locations (20)
California
- City of Hope National Medical Center /ID# 273338 — Duarte
- Valkyrie Clinical Trials /ID# 269935 — Los Angeles
- Desert Regional Medical Center /ID# 272437 — Palm Springs
Utah
- Community Cancer Trials Of Utah /ID# 271715 — Ogden
- Utah Cancer Specialists - Salt Lake City /ID# 268603 — Salt Lake City
- Veterans Affairs Medical Center - Salt Lake City /ID# 265329 — Salt Lake City
Illinois
- Rush University Medical Center /ID# 242103 — Chicago
- City Of Hope - Chicago /ID# 274430 — Zion
Colorado
- Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823 — Golden
Georgia
- City Of Hope - Atlanta. /ID# 273092 — Newnan
Indiana
- Northwest Cancer Center - Dyer Clinic /ID# 269787 — Dyer
Kansas
- Cancer Center of Kansas - Wichita /ID# 270117 — Wichita
Kentucky
- University of Kentucky Chandler Medical Center. /ID# 242087 — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06508658
The ClinicalTrials.gov registry entry for NCT06508658 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Epcoritamab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06508658 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Utah, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06508658 about?
NCT06508658 is a clinical study titled "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". 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 ad...
What is the current status of trial NCT06508658?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2024-08-13. Estimated completion is 2028-01.
What conditions does trial NCT06508658 study?
This clinical trial studies the following conditions: Diffuse Large B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06508658?
The interventions under investigation include: Epcoritamab (DRUG), Oxaliplatin (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06508658?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06508658 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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