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
Condition(s) studied
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.
Eligibility
Primary outcome measure(s)
- Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events — Up to 3 Months
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity. - Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events — Up to 3 Months
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity. - Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events — Up to 3 Months
Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.
Trial sites (72)
| Facility | City | Region | Status |
|---|---|---|---|
| Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630 | Mobile | Alabama | |
| University of Arkansas for Medical Sciences /ID# 244562 | Little Rock | Arkansas | |
| Highlands Oncology Group, PA /ID# 245002 | Springdale | Arkansas | |
| Beverly Hills Cancer Center /ID# 255327 | Beverly Hills | California | |
| Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133 | Fountain Valley | California | |
| UCSF Fresno /ID# 263286 | Fresno | California | |
| University of California, Los Angeles /ID# 244573 | Los Angeles | California | |
| Rocky Mountain Cancer Centers - Boulder /ID# 247653 | Boulder | Colorado | |
| Bennett Cancer Center - Stamford Hospital /ID# 244530 | Stamford | Connecticut | |
| MedStar Washington Hospital Center /ID# 246068 | Washington D.C. | District of Columbia | |
| Cancer Specialists of North Florida /ID# 261842 | Jacksonville | Florida | |
| Florida Cancer Specialists /ID# 260854 | Lake Mary | Florida | |
| Mount Sinai Medical Center-Miami Beach /ID# 249045 | Miami Beach | Florida | |
| Memorial Hospital West /ID# 248432 | Pembroke Pines | Florida | |
| BRCR Medical Center Inc /ID# 262527 | Tamarac | Florida | |
| Cleveland Clinic Florida /ID# 244532 | Weston | Florida | |
| Emory University, Winship Cancer Institute /ID# 246056 | Atlanta | Georgia | |
| University of Illinois at Chicago /ID# 245038 | Chicago | Illinois | |
| Illinois Cancer Specialists /ID# 247655 | Niles | Illinois | |
| Parkview Comprehensive Cancer Center /ID# 244545 | Fort Wayne | Indiana | |
| Indiana Blood & Marrow Transpl /ID# 244971 | Indianapolis | Indiana | |
| University of Iowa Health Care /ID# 258227 | Des Moines | Iowa | |
| Our Lady Of The Lake Regional Medical Center /ID# 255008 | Baton Rouge | Louisiana | |
| American Oncology Partners of Maryland /ID# 244968 | Bethesda | Maryland | |
| Maryland Oncology Hematology /ID# 254192 | Columbia | Maryland | |
| Tufts Medical Center /ID# 246074 | Boston | Massachusetts | |
| Massachusetts General Hospital /ID# 245239 | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center /ID# 248651 | Boston | Massachusetts | |
| Cancer & Hematology Centers of Western Michigan - East /ID# 244985 | Grand Rapids | Michigan | |
| Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547 | Ypsilanti | Michigan | |
| Hattiesburg Clinic /ID# 244980 | Hattiesburg | Mississippi | |
| St. Luke's Hospital - Chesterfield /ID# 247815 | Chesterfield | Missouri | |
| NHO - Nebraska Hematology-Oncology /ID# 263164 | Lincoln | Nebraska | |
| Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003 | Lebanon | New Hampshire | |
| The John Theurer Cancer /ID# 262532 | Hackensack | New Jersey | |
| Morristown Medical Center /ID# 244973 | Morristown | New Jersey | |
| University of New Mexico /ID# 252434 | Albuquerque | New Mexico | |
| New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681 | New Hyde Park | New York | |
| Stony Brook University Medical Center /ID# 244631 | New York | New York | |
| New York Cancer and Blood Specialists - New York /ID# 264676 | New York | New York |
+ 32 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05451810 on ClinicalTrials.gov ↗ ← All trials in the USA