Non Hodgkin Lymphoma Clinical Trial

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 Follicular Lymphoma

Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). 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) or R/R follicular lymphoma (FL). Adverse events will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R FL. 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 80 adult participants with R/R DLBCL and R/R FL will be enrolled in the study in approximately 40 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:

Participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.

Must have 1 or more measurable disease sites:

Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis >= 1.0 cm.
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Adequate organ function.

Exclusion Criteria:

- Central nervous system (CNS) involvement.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT05451810

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 41 Locations for this study

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University of Arkansas for Medical Sciences /ID# 244562
Little Rock Arkansas, 72205, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
Fountain Valley California, 92708, United States More Info
Site Coordinator
Contact
(714) 698-0300
Rocky Mountain Cancer Centers /ID# 247653
Boulder Colorado, 80303, United States
Bennett Cancer Center - Stamford Hospital /ID# 244530
Stamford Connecticut, 06902, United States
Mount Sinai Medical Center-Miami Beach /ID# 249045
Miami Beach Florida, 33140, United States
Miami Cancer Institute Baptist Health South Florida /ID# 244972
Miami Florida, 33176, United States
Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432
Pembroke Pines Florida, 33028, United States
Cleveland Clinic Florida /ID# 244532
Weston Florida, 33331, United States
Beacon Cancer Care /ID# 245018
Coeur d'Alene Idaho, 83814, United States
University of Illinois - Chicago /ID# 245038
Chicago Illinois, 60607, United States
Illinois Cancer Specialists /ID# 247655
Niles Illinois, 60714, United States
Parkview Cancer Institute /ID# 244545
Fort Wayne Indiana, 46845, United States More Info
Site Coordinator
Contact
1-833-724-8326
Indiana Blood & Marrow Transpl /ID# 244971
Indianapolis Indiana, 46237, United States
American Oncology Partners of Maryland, PA /ID# 244968
Bethesda Maryland, 20817, United States More Info
Site Coordinator
Contact
301-571-2016
Tufts Medical Center /ID# 246074
Boston Massachusetts, 02111, United States
Massachusetts General Hospital /ID# 245239
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center /ID# 248651
Boston Massachusetts, 02215, United States
St. Joseph Mercy Hospital /ID# 244547
Ypsilanti Michigan, 48197, United States
Hattiesburg Clinic /ID# 244980
Hattiesburg Mississippi, 39401, United States More Info
Site Coordinator
Contact
601-261-1700
St. Luke's Hospitals /ID# 247815
Chesterfield Missouri, 63017, United States
David C. Pratt Cancer Center /ID# 244986
Saint Louis Missouri, 63141, United States
Dartmouth-Hitchcock Medical Center /ID# 245003
Lebanon New Hampshire, 03756, United States
Morristown Medical Center /ID# 244973
Morristown New Jersey, 07960, United States
Rutgers Cancer Institute of New Jersey /ID# 248235
New Brunswick New Jersey, 08901, United States
Stony Brook University Medical Center /ID# 244631
New York New York, 10021, United States
East Carolina University Brody School of Medicine /ID# 248989
Greenville North Carolina, 27834, United States
Wake Forest Univ HS /ID# 245005
Winston-Salem North Carolina, 27157, United States
Oncology Hematology Care, Inc. /ID# 246182
Cincinnati Ohio, 45236, United States
Toledo Clinic Cancer Center /ID# 246852
Toledo Ohio, 43623, United States
University of Oklahoma, Stephenson Cancer Center /ID# 244568
Oklahoma City Oklahoma, 73104, United States
Willamette Valley Cancer Institute and Research Center /ID# 246410
Eugene Oregon, 97401, United States
Lehigh Valley Hospital-Cedar Crest /ID# 244984
Allentown Pennsylvania, 18103, United States More Info
Site Coordinator
Contact
610-402-9543
Penn State Milton S. Hershey Medical Center /ID# 244979
Hershey Pennsylvania, 17033, United States
UPMC Hillman Cancer Ctr /ID# 244571
Pittsburgh Pennsylvania, 15232, United States
Medical University of South Carolina /ID# 249968
Charleston South Carolina, 29425, United States
Prisma Health Cancer Institute-Faris Road /ID# 247654
Greenville South Carolina, 29605, United States
Texas Oncology - Austin Midtown /ID# 247656
Austin Texas, 78705, United States
Texas Oncology - San Antonio Medical Center /ID# 247658
San Antonio Texas, 78240, United States
Texas Oncology - Northeast Texas /ID# 247657
Tyler Texas, 75702, United States
Virginia Cancer Specialists - Gainesville /ID# 248760
Gainesville Virginia, 20155, United States
Northwest Medical Specialties - Tacoma /ID# 245045
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT05451810

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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