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 Classic 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 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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

184

Study ID:

NCT05451810

Recruitment Status:

Recruiting

Sponsor:

Genmab

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There are 53 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences /ID# 244562
Little Rock Arkansas, 72205, United States
Highlands Oncology Group, PA /ID# 245002
Springdale Arkansas, 72762, United States
Beverly Hills Cancer Center /ID# 255327
Beverly Hills California, 90211, 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
University of California, Los Angeles /ID# 244573
Los Angeles California, 90095, United States
Rocky Mountain Cancer Centers - Boulder /ID# 247653
Boulder Colorado, 80303, United States
Bennett Cancer Center - Stamford Hospital /ID# 244530
Stamford Connecticut, 06902, United States
MedStar Washington Hospital Center /ID# 246068
Washington District of Columbia, 20010, United States
Mount Sinai Medical Center-Miami Beach /ID# 249045
Miami Beach Florida, 33140, United States
Memorial Hospital West /ID# 248432
Pembroke Pines Florida, 33028, United States
Cleveland Clinic Florida /ID# 244532
Weston Florida, 33331, United States
University of Illinois at Chicago /ID# 245038
Chicago Illinois, 60607, United States
Illinois Cancer Specialists /ID# 247655
Niles Illinois, 60714, United States
Parkview Comprehensive Cancer Center /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
Mission Cancer and Blood /ID# 258227
Des Moines Iowa, 50314, United States More Info
Site Coordinator
Contact
515-282-2921
Our Lady of the Lake Regional Medical Center /ID# 255008
Baton Rouge Louisiana, 70808, United States
American Oncology Partners of Maryland /ID# 244968
Bethesda Maryland, 20817, United States More Info
Site Coordinator
Contact
301-571-2016
Maryland Oncology Hematology /ID# 254192
Columbia Maryland, 21044, United States
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
Cancer & Hematology Centers of Western Michigan - East /ID# 244985
Grand Rapids Michigan, 49546, United States More Info
Site Coordinator
Contact
(616) 954-9800
Trinity Health St. Joseph Mercy Ann Arbor /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 Hospital - Chesterfield /ID# 247815
Chesterfield Missouri, 63017, 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
University of New Mexico /ID# 252434
Albuquerque New Mexico, 87102, United States
Stony Brook University Medical Center /ID# 244631
New York New York, 10021, United States
New York Cancer and Blood Specialists /ID# 259016
Port Jefferson Station New York, 11776, 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 - Main /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
Oregon Oncology Specialists in Salem /ID# 260570
Salem Oregon, 97301, 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
Reading Hospital; McGlinn Cancer Institute /ID# 259181
West Reading Pennsylvania, 19611, United States
Prisma Health /ID# 247654
Greenville South Carolina, 29605, United States
The West Clinic /ID# 245004
Memphis Tennessee, 38120, United States More Info
Site Coordinator
Contact
901-683-0055
Texas Oncology - Austin Midtown /ID# 247656
Austin Texas, 78705, United States
University of Texas Southwestern Medical Center /ID# 244552
Dallas Texas, 75390, 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
Blue Ridge Cancer Center /ID# 260597
Roanoke Virginia, 24014, United States
Northwest Medical Specialties - Tacoma /ID# 245045
Tacoma Washington, 98405, United States
Pan American Center for Oncology Trials, LLC /ID# 254952
Rio Piedras , 00935, Puerto Rico
Auxilio Mutuo Cancer Center /ID# 254953
San Juan , 00918, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

184

Study ID:

NCT05451810

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

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