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NCT05451810 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma
A Phase 2 study of Diffuse Large B Cell Lymphoma and Classic Follicular Lymphoma, sponsored by Genmab.
- Active
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
- 20
- Study locations
NCT05451810: Active Phase 2 study of Diffuse Large B Cell Lymphoma and Classic Follicular Lymphoma, sponsored by Genmab.
NCT05451810 is a Phase 2 study of Diffuse Large B Cell Lymphoma and Classic Follicular Lymphoma that is active but no longer recruiting, run by Genmab. The registered enrollment target is 184 participants, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05451810, a Phase 2 study of Diffuse Large B Cell Lymphoma and Classic Follicular Lymphoma, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 184 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). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Primary Outcome
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Conditions Studied
Interventions
- DRUG Epcoritamab
Study Locations (20)
Florida
- Cancer Specialists of North Florida /ID# 261842 - Jacksonville
- Florida Cancer Specialists /ID# 260854 - Lake Mary
- Mount Sinai Medical Center-Miami Beach /ID# 249045 - Miami Beach
- Memorial Hospital West /ID# 248432 - Pembroke Pines
- BRCR Medical Center Inc /ID# 262527 - Tamarac
- Cleveland Clinic Florida /ID# 244532 - Weston
California
- Beverly Hills Cancer Center /ID# 255327 - Beverly Hills
- Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 - Fountain Valley
- UCSF Fresno /ID# 263286 - Fresno
- University of California, Los Angeles /ID# 244573 - Los Angeles
Arkansas
- University of Arkansas for Medical Sciences /ID# 244562 - Little Rock
- Highlands Oncology Group, PA /ID# 245002 - Springdale
Illinois
- University of Illinois at Chicago /ID# 245038 - Chicago
- Illinois Cancer Specialists /ID# 247655 - Niles
Alabama
- Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 - Mobile
Colorado
- Rocky Mountain Cancer Centers - Boulder /ID# 247653 - Boulder
Connecticut
- Bennett Cancer Center - Stamford Hospital /ID# 244530 - Stamford
District of Columbia
- MedStar Washington Hospital Center /ID# 246068 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT05451810 still lists
NCT05451810 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (15% lower).
The record links to 2 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Epcoritamab is the first listed.
NCT05451810 names 20 study sites across 10 states, led by Florida, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05451810 about?
NCT05451810 is a clinical study titled "A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma". B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in r...
What is the current status of trial NCT05451810?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2022-08-17. Estimated completion is 2027-03.
What conditions does trial NCT05451810 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Classic Follicular Lymphoma.
What interventions are being tested in trial NCT05451810?
The interventions under investigation include: Epcoritamab (DRUG).
Who is sponsoring clinical trial NCT05451810?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05451810 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05451810's enrollment target sits among peer trials
184 32nd of 114 higher than 83 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.
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