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
NCT ID: NCT05451810
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
184 participants
INTERVENTIONAL
2022-08-17
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Epcoritamab
Subcutaneous Injection (SC)
Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL)
Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Diversity Enriched Cohort: Epcoritamab DLBCL
Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Diversity Enriched Cohort: Epcoritamab cFL
Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Epcoritamab
Subcutaneous Injection (SC)
Interventions
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Epcoritamab
Subcutaneous Injection (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets the following disease activity criteria:
\-- Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL):
* Documented CD20+ mature B-cell neoplasm according to the the 5th edition of World Health Organization (WHO) classification of Haematolymphoid Tumours, based on most recent representative pathology report;
* Diffuse large B-cell lymphoma, not otherwise specified (NOS) (de novo or transformed from follicular lymphoma (FL) or Marginal Zone Lymphoma \[MZL\]);
* High-grade B-cell Lymphoma including "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2022 or 2016 as high-grade B-cell lymphoma \[HGBCL\], with MYC and BCL2 and/or BCL6 translocations).
* Follicular large B-cell lymphoma (FLBL, formerly FL grade 3B);
* Relapsed or refractory disease and previously treated with at least 1 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
* Either failed prior autologous hematopoietic stem cell transplantation (HSCT), or ineligible for autologous HSCT including but not limited to age, Eastern Cooperative Oncology Group (ECOG) performance status, participant decision, comorbidities and/or insufficient response to prior treatment.
* R/R Follicular Lymphoma:
* Documented CD20+ mature B-cell neoplasm according to the 5th edition of WHO classification of Haematolymphoid Tumours, based on representative pathology report;
\--- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation;
* Relapsed or refractory disease and previously treated with at least 2 prior lines of systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
* Previously treated with an alkylating agent or lenalidomide;
* Relapsed or refractory to the last prior line therapy. Previous lymphoma therapy is defined as 1 of the following: At least 2 months of single-agent therapy, at least 2 consecutive cycles of combination therapy, autologous HSCT, immunomodulatory therapy, or radioimmunotherapy.
* Has at least one target lesion defined as:
* \>= 1 measurable nodal lesion (long axis \> 1.5 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 ECOG performance status 0 - 2.
* Must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug:
* Absolute neutrophil count (ANC) \>= 1.0 × 10\^9/L (growth factor support allowed in case of bone marrow involvement, but participant must have not received growth factor within 14 days prior to screening lab collection);
* Hemoglobin \>= 8.0 g/dL (RBC transfusions permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection);
* Platelet count \>= 75 × 10\^9/L, or \>= 50 × 10\^9/L in the presence of bone marrow involvement or splenomegaly (platelet transfusions are permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection);
* International normalized ratio (INR) (or Prothrombin Time \[PT\]) and aPTT \<= 1.5 × upper limit of normal (ULN), unless receiving anticoagulation
* Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) \<= 3.0 × upper limit of normal (ULN); unless due to hepatic involvement of disease or non-hepatic origin. For participants with hepatic involvement of disease, serum AST and serum ALT \<= 5.0 × ULN
* Direct bilirubin \<= 2 × ULN;
* Estimated creatine clearance (CrCl) as calculated by Cockcroft-Gault Formula \>= 45 mL/min, or estimated glomerular filtration rate (eGFR) as calculated by Modification of Diet in Renal Disease \[MDRD\] equation \>= 45 mL/min;
* Lymphocyte count \< 5 × 10\^9/L.
Exclusion Criteria
* 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 participant 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630
Mobile, Alabama, United States
University of Arkansas for Medical Sciences /ID# 244562
Little Rock, Arkansas, United States
Highlands Oncology Group, PA /ID# 245002
Springdale, Arkansas, United States
Beverly Hills Cancer Center /ID# 255327
Beverly Hills, California, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
Fountain Valley, California, United States
UCSF Fresno /ID# 263286
Fresno, 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
MedStar Washington Hospital Center /ID# 246068
Washington D.C., District of Columbia, United States
Cancer Specialists of North Florida /ID# 261842
Jacksonville, Florida, United States
Florida Cancer Specialists /ID# 260854
Lake Mary, Florida, United States
Mount Sinai Medical Center-Miami Beach /ID# 249045
Miami Beach, Florida, United States
Memorial Hospital West /ID# 248432
Pembroke Pines, Florida, United States
BRCR Medical Center Inc /ID# 262527
Tamarac, Florida, United States
Cleveland Clinic Florida /ID# 244532
Weston, Florida, United States
Emory University, Winship Cancer Institute /ID# 246056
Atlanta, Georgia, United States
University of Illinois at Chicago /ID# 245038
Chicago, Illinois, United States
Illinois Cancer Specialists /ID# 247655
Niles, Illinois, United States
Parkview Comprehensive Cancer Center /ID# 244545
Fort Wayne, Indiana, United States
Indiana Blood & Marrow Transpl /ID# 244971
Indianapolis, Indiana, United States
University of Iowa Health Care /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 /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
NHO - Nebraska Hematology-Oncology /ID# 263164
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003
Lebanon, New Hampshire, United States
The John Theurer Cancer /ID# 262532
Hackensack, New Jersey, United States
Morristown Medical Center /ID# 244973
Morristown, New Jersey, United States
University of New Mexico /ID# 252434
Albuquerque, New Mexico, United States
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681
New Hyde Park, New York, United States
Stony Brook University Medical Center /ID# 244631
New York, New York, United States
New York Cancer and Blood Specialists - New York /ID# 264676
New York, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 258610
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628
New York, New York, United States
New York Cancer and Blood Specialists /ID# 259016
Port Jefferson Station, New York, United States
New York Cancer and Blood Specialists - Bronx /ID# 264690
The Bronx, 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
OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803
Columbus, 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
Spoknwrd Clinical Trials /ID# 265232
Easton, 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
Vanderbilt University Medical Center /ID# 260953
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown /ID# 247656
Austin, Texas, United States
Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659
Dallas, Texas, United States
Texas Oncology - Dallas - Worth Street /ID# 262956
Dallas, 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
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514
Norfolk, 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
Countries
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Related Links
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Other Identifiers
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M23-362
Identifier Type: -
Identifier Source: org_study_id
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