Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting
Study ID: NCT05451810
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences /ID# 244562, Little Rock, Arkansas, United States
Highlands Oncology Group, PA /ID# 245002, Springdale, Arkansas, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133, Fountain Valley, California, United States
University of California, Los Angeles /ID# 244573, Los Angeles, California, United States
Rocky Mountain Cancer Centers - Boulder /ID# 247653, Boulder, Colorado, United States
Bennett Cancer Center - Stamford Hospital /ID# 244530, Stamford, Connecticut, United States
Mount Sinai Medical Center-Miami Beach /ID# 249045, Miami Beach, Florida, United States
Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432, Pembroke Pines, Florida, United States
Cleveland Clinic Florida /ID# 244532, Weston, Florida, United States
University of Illinois at Chicago /ID# 245038, Chicago, Illinois, United States
Illinois Cancer Specialists /ID# 247655, Niles, Illinois, United States
Parkview Cancer Institute /ID# 244545, Fort Wayne, Indiana, United States
Indiana Blood & Marrow Transpl /ID# 244971, Indianapolis, Indiana, United States
Mission Cancer and Blood /ID# 258227, Des Moines, Iowa, United States
Our Lady of the Lake Regional Medical Center /ID# 255008, Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland, PA /ID# 244968, Bethesda, Maryland, United States
Maryland Oncology Hematology /ID# 254192, Columbia, Maryland, United States
Tufts Medical Center /ID# 246074, Boston, Massachusetts, United States
Massachusetts General Hospital /ID# 245239, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 248651, Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan - East /ID# 244985, Grand Rapids, Michigan, United States
Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547, Ypsilanti, Michigan, United States
Hattiesburg Clinic /ID# 244980, Hattiesburg, Mississippi, United States
St. Luke's Hospital - Chesterfield /ID# 247815, Chesterfield, Missouri, United States
Dartmouth-Hitchcock Medical Center /ID# 245003, Lebanon, New Hampshire, United States
Morristown Medical Center /ID# 244973, Morristown, New Jersey, United States
University of New Mexico /ID# 252434, Albuquerque, New Mexico, United States
Stony Brook University Medical Center /ID# 244631, New York, New York, United States
New York Cancer and Blood Specialists /ID# 259016, Port Jefferson Station, New York, United States
East Carolina University - Brody School of Medicine /ID# 248989, Greenville, North Carolina, United States
Wake Forest Univ HS /ID# 245005, Winston-Salem, North Carolina, United States
Oncology Hematology Care, Inc. /ID# 246182, Cincinnati, Ohio, United States
Toledo Clinic Cancer Center - Main /ID# 246852, Toledo, Ohio, United States
University of Oklahoma, Stephenson Cancer Center /ID# 244568, Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center /ID# 246410, Eugene, Oregon, United States
Oregon Oncology Specialists in Salem /ID# 260570, Salem, Oregon, United States
Lehigh Valley Hospital-Cedar Crest /ID# 244984, Allentown, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center /ID# 244979, Hershey, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 244571, Pittsburgh, Pennsylvania, United States
Reading Hospital; McGlinn Cancer Institute /ID# 259181, West Reading, Pennsylvania, United States
Prisma Health /ID# 247654, Greenville, South Carolina, United States
The West Clinic /ID# 245004, Memphis, Tennessee, United States
Texas Oncology - Austin Midtown /ID# 247656, Austin, Texas, United States
University of Texas Southwestern Medical Center /ID# 244552, Dallas, Texas, United States
Texas Oncology - San Antonio Medical Center /ID# 247658, San Antonio, Texas, United States
Texas Oncology - Northeast Texas /ID# 247657, Tyler, Texas, United States
Virginia Cancer Specialists - Gainesville /ID# 248760, Gainesville, Virginia, United States
Blue Ridge Cancer Center /ID# 260597, Roanoke, Virginia, United States
Northwest Medical Specialties - Tacoma /ID# 245045, Tacoma, Washington, United States
Pan American Center for Oncology Trials, LLC /ID# 254952, Rio Piedras, , Puerto Rico
Auxilio Mutuo Cancer Center /ID# 254953, San Juan, , Puerto Rico
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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