Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06508658 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Genmab.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT06508658: Recruiting Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Genmab.
NCT06508658 is a Phase 3 study of Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by Genmab. The registered enrollment target is 360 participants, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06508658, a Phase 3 study of Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by Genmab.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.
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 |
What NCT06508658 shows while recruiting
NCT06508658 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (67% higher).
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.
NCT06508658 names 20 study sites across 15 states, led by California, Utah, Illinois.
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.
What interventions are being tested in trial NCT06508658?
The interventions under investigation include: Epcoritamab (DRUG), Oxaliplatin (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT06508658?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06508658's enrollment target sits among peer trials
360 16th of 114 higher than 99 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Long-term Extension Study of PCI-32765 (Ibrutinib)
RECRUITING · Phase 3
-
A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
RECRUITING · Phase 3
-
Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
ACTIVE NOT RECRUITING · Phase 3
-
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
ACTIVE NOT RECRUITING · Phase 3
-
A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
ACTIVE NOT RECRUITING · Phase 3
-
Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02747836 · 360 participants
Ultrasound Analysis of Human Carpal Tunnel System
- NCT04089046 · 360 participants · NA
Telemedicine Enhanced Asthma Management - Uniting Providers for Teens (TEAM-UP for Teens)
- NCT04130503 · 360 participants · NA
The Recovery in Stroke Using PAP Study
- NCT04160000 · 360 participants · Phase 4
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI