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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Classic Follicular Lymphoma (cFL), with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative and most recent pathology report: - Can include 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 1 prior systemic anti-lymphoma therapy for DLBCL and 2 prior systemic antineoplastic therapies for cFL including at least 1 anti-CD20 monoclonal antibody-containing therapy - Has at least one target lesion defined as: - ≥ 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) and/or ≥ 1 measurable extranodal lesion (long axis > 1.0 cm) on CT (or MRI) AND - FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites. - Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. - Adequate organ function.

Exclusion Criteria

  • Central nervous system (CNS) involvement by lymphoma. - 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 subject 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL) 		Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013
Experimental
Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL) 		Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013
Experimental
Diversity Enriched Cohort: Epcoritamab DLBCL 		Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013
Experimental
Diversity Enriched Cohort: Epcoritamab cFL 		Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other names:
    • ABBV-GMAB-3013

Recruiting Locations

University of Arkansas for Medical Sciences /ID# 244562
Little Rock, Arkansas 72205

Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
Fountain Valley, California 92708-7501
Contact:
Site Coordinator
(714) 698-0300

University of California, Los Angeles /ID# 244573
Los Angeles, California 90095

Rocky Mountain Cancer Centers /ID# 247653
Boulder, Colorado 80303

Bennett Cancer Center - Stamford Hospital /ID# 244530
Stamford, Connecticut 06902-3602

Mount Sinai Medical Center-Miami Beach /ID# 249045
Miami Beach, Florida 33140-2948

Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432
Pembroke Pines, Florida 33028-1023

Cleveland Clinic Florida /ID# 244532
Weston, Florida 33331-3609

University of Illinois at Chicago /ID# 245038
Chicago, Illinois 60607

Illinois Cancer Specialists /ID# 247655
Niles, Illinois 60714

Parkview Cancer Institute /ID# 244545
Fort Wayne, Indiana 46845-1739
Contact:
Site Coordinator
1-833-724-8326

Indiana Blood & Marrow Transpl /ID# 244971
Indianapolis, Indiana 46237

Mission Cancer and Blood /ID# 258227
Des Moines, Iowa 50314-3017
Contact:
Site Coordinator
515-282-2921

Our Lady of the Lake Regional Medical Center /ID# 255008
Baton Rouge, Louisiana 70808-4375

American Oncology Partners of Maryland, PA /ID# 244968
Bethesda, Maryland 20817
Contact:
Site Coordinator
301-571-2016

Maryland Oncology Hematology /ID# 254192
Columbia, Maryland 21044-3128

Tufts Medical Center /ID# 246074
Boston, Massachusetts 02111

Massachusetts General Hospital /ID# 245239
Boston, Massachusetts 02114

Beth Israel Deaconess Medical Center /ID# 248651
Boston, Massachusetts 02215-5400

Cancer & Hematology Centers of Western Michigan - East /ID# 244985
Grand Rapids, Michigan 49546-7062
Contact:
Site Coordinator
(616) 954-9800

Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547
Ypsilanti, Michigan 48197-1051

Hattiesburg Clinic /ID# 244980
Hattiesburg, Mississippi 39401
Contact:
Site Coordinator
601-261-1700

St. Luke's Hospital - Chesterfield /ID# 247815
Chesterfield, Missouri 63017

Dartmouth-Hitchcock Medical Center /ID# 245003
Lebanon, New Hampshire 03756

Morristown Medical Center /ID# 244973
Morristown, New Jersey 07960-6136

University of New Mexico /ID# 252434
Albuquerque, New Mexico 87102-4517

Stony Brook University Medical Center /ID# 244631
New York, New York 10021

New York Cancer and Blood Specialists /ID# 259016
Port Jefferson Station, New York 11776-8060

East Carolina University Brody School of Medicine /ID# 248989
Greenville, North Carolina 27834

Wake Forest Univ HS /ID# 245005
Winston-Salem, North Carolina 27157

Oncology Hematology Care, Inc. /ID# 246182
Cincinnati, Ohio 45236-2725

Toledo Clinic Cancer Center /ID# 246852
Toledo, Ohio 43623

University of Oklahoma, Stephenson Cancer Center /ID# 244568
Oklahoma City, Oklahoma 73104-5418

Willamette Valley Cancer Institute and Research Center /ID# 246410
Eugene, Oregon 97401-6043

Oregon Oncology Specialists in Salem /ID# 260570
Salem, Oregon 97301-3975

Lehigh Valley Hospital-Cedar Crest /ID# 244984
Allentown, Pennsylvania 18103-6202
Contact:
Site Coordinator
610-402-9543

Penn State Milton S. Hershey Medical Center /ID# 244979
Hershey, Pennsylvania 17033-2360

UPMC Hillman Cancer Ctr /ID# 244571
Pittsburgh, Pennsylvania 15232

Reading Hospital; McGlinn Cancer Institute /ID# 259181
West Reading, Pennsylvania 19611-2143

Prisma Health /ID# 247654
Greenville, South Carolina 29605

The West Clinic /ID# 245004
Memphis, Tennessee 38120
Contact:
Site Coordinator
901-683-0055

Texas Oncology - Austin Midtown /ID# 247656
Austin, Texas 78705

University of Texas Southwestern Medical Center /ID# 244552
Dallas, Texas 75390-7208

Texas Oncology - San Antonio Medical Center /ID# 247658
San Antonio, Texas 78240-5251

Texas Oncology - Northeast Texas /ID# 247657
Tyler, Texas 75702

Virginia Cancer Specialists - Gainesville /ID# 248760
Gainesville, Virginia 20155-3257

Blue Ridge Cancer Center /ID# 260597
Roanoke, Virginia 24014-2419

Northwest Medical Specialties - Tacoma /ID# 245045
Tacoma, Washington 98405

Pan American Center for Oncology Trials, LLC /ID# 254952
Rio Piedras, Puerto Rico 00935

Auxilio Mutuo Cancer Center /ID# 254953
San Juan, Puerto Rico 00918

More Details

NCT ID
NCT05451810
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.