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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 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.

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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.

Conditions Studied

Diffuse Large B Cell Lymphoma Classic Follicular Lymphoma

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

FieldValue
Enrollment Target 184 participants
Start Date 2022-08-17
Est. Completion 2027-03
Phase Phase 2

Sponsor

Genmab

45 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05451810

The ClinicalTrials.gov registry entry for NCT05451810 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (15% lower). The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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