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 (NCT05451810)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (3 items).
Location: Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 โ Mobile, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Have a primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.
- Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If participant has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (72 Sites)
- Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 โ Mobile, Alabama
- University of Arkansas for Medical Sciences /ID# 244562 โ Little Rock, Arkansas
- Highlands Oncology Group, PA /ID# 245002 โ Springdale, Arkansas
- Beverly Hills Cancer Center /ID# 255327 โ Beverly Hills, California
- Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 โ Fountain Valley, California
- UCSF Fresno /ID# 263286 โ Fresno, California
- University of California, Los Angeles /ID# 244573 โ Los Angeles, California
- Rocky Mountain Cancer Centers - Boulder /ID# 247653 โ Boulder, Colorado
- Bennett Cancer Center - Stamford Hospital /ID# 244530 โ Stamford, Connecticut
- MedStar Washington Hospital Center /ID# 246068 โ Washington D.C., District of Columbia
- Cancer Specialists of North Florida /ID# 261842 โ Jacksonville, Florida
- Florida Cancer Specialists /ID# 260854 โ Lake Mary, Florida
- Mount Sinai Medical Center-Miami Beach /ID# 249045 โ Miami Beach, Florida
- Memorial Hospital West /ID# 248432 โ Pembroke Pines, Florida
- BRCR Medical Center Inc /ID# 262527 โ Tamarac, Florida
- Cleveland Clinic Florida /ID# 244532 โ Weston, Florida
- Emory University, Winship Cancer Institute /ID# 246056 โ Atlanta, Georgia
- University of Illinois at Chicago /ID# 245038 โ Chicago, Illinois
- Illinois Cancer Specialists /ID# 247655 โ Niles, Illinois
- Parkview Comprehensive Cancer Center /ID# 244545 โ Fort Wayne, Indiana
- Indiana Blood & Marrow Transpl /ID# 244971 โ Indianapolis, Indiana
- University of Iowa Health Care /ID# 258227 โ Des Moines, Iowa
- Our Lady Of The Lake Regional Medical Center /ID# 255008 โ Baton Rouge, Louisiana
- American Oncology Partners of Maryland /ID# 244968 โ Bethesda, Maryland
- Maryland Oncology Hematology /ID# 254192 โ Columbia, Maryland
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.