Phase
Condition
Follicular Lymphoma
Lymphoma, B-cell
Lymphoproliferative Disorders
Treatment
Epcoritamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Life expectancy >3 months on standard of care (SOC) treatment.
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 ofWorld 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 ortransformed 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 priorsystemic antineoplastic therapies including at least 1 anti-CD20 monoclonalantibody-containing therapy; Note: Relapsed disease is defined as disease thatpreviously responded to therapy but progressed >= 6 months after completion oftherapy. Refractory disease is defined as disease that either progressed duringtherapy, failed to achieve an objective response to prior therapy, orprogressed within 6 months after completion of therapy (including maintenancetherapy).
Either failed prior autologous hematopoietic stem cell transplantation (HSCT),or ineligible for autologous HSCT including but not limited to age, EasternCooperative 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 WHOclassification of Haematolymphoid Tumours, based on representative pathologyreport; --- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical orpathological evidence of transformation;
Relapsed or refractory disease and previously treated with at least 2 priorlines of systemic antineoplastic therapies including at least 1 anti-CD20monoclonal antibody containing therapy; Note: Relapsed disease is defined asdisease that previously responded to therapy but progressed >= 6 months aftercompletion of therapy. Refractory disease is defined as disease that eitherprogressed during therapy, failed to achieve an objective response to priortherapy, or progressed within 6 months after completion of therapy (includingmaintenance therapy).
Previously treated with an alkylating agent or lenalidomide;
Relapsed or refractory to the last prior line therapy. Previous lymphomatherapy is defined as 1 of the following: At least 2 months of single-agenttherapy, 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 measurableextranodal 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 thescreening period prior to the first dose of study drug:
Absolute neutrophil count (ANC) >= 1.0 × 10^9/L (growth factor support allowedin case of bone marrow involvement, but participant must have not receivedgrowth factor within 14 days prior to screening lab collection);
Hemoglobin >= 8.0 g/dL (RBC transfusions permitted, but participants must nothave received blood transfusions within 7 days prior to Screening labcollection);
Platelet count >= 75 × 10^9/L, or >= 50 × 10^9/L in the presence of bone marrowinvolvement or splenomegaly (platelet transfusions are permitted, butparticipants must not have received blood transfusions within 7 days prior toScreening 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 ofdisease or non-hepatic origin. For participants with hepatic involvement ofdisease, 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 byModification of Diet in Renal Disease [MDRD] equation >= 45 mL/min;
Lymphocyte count < 5 × 10^9/L.
Exclusion
Exclusion Criteria:
Have a primary central nervous system (CNS) lymphoma or known CNS involvement bylymphoma including leptomeningeal disease, at screening as confirmed by magneticresonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinicallyindicated, by lumbar puncture.
Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that isundetectable and controlled with medication for at least 1 year prior to enrollmentis allowed. Note: If participant has no history of HIV infection, HIV testing doesnot need to be conducted at screening unless it is required per local guidelines orinstitutional standards.
Study Design
Connect with a study center
Pan American Center for Oncology Trials, LLC /ID# 254952
Rio Piedras, 00935
Puerto RicoSite Not Available
Auxilio Mutuo Cancer Center /ID# 254953
San Juan, 00918
Puerto RicoSite Not Available
Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630
Mobile, Alabama 36607
United StatesSite Not Available
University of Arkansas for Medical Sciences /ID# 244562
Little Rock, Arkansas 72205
United StatesSite Not Available
Highlands Oncology Group, PA /ID# 245002
Springdale, Arkansas 72762
United StatesSite Not Available
Beverly Hills Cancer Center /ID# 255327
Beverly Hills, California 90211
United StatesSite Not Available
Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133
Fountain Valley, California 92708-7501
United StatesSite Not Available
UCSF Fresno /ID# 263286
Fresno, California 93701-2302
United StatesSite Not Available
University of California, Los Angeles /ID# 244573
Los Angeles, California 90095
United StatesSite Not Available
Kaiser Permanente Medical Ctr-Vallejo /ID# 244989
Vallejo, California 94589-2441
United StatesSite Not Available
Rocky Mountain Cancer Centers - Boulder /ID# 247653
Boulder, Colorado 80303
United StatesSite Not Available
Rocky Mountain Cancer Centers /ID# 247653
Boulder, Colorado 80303
United StatesActive - Recruiting
Bennett Cancer Center - Stamford Hospital /ID# 244530
Stamford, Connecticut 06902-3602
United StatesSite Not Available
MedStar Washington Hospital Center /ID# 246068
Washington, District of Columbia 20010
United StatesSite Not Available
Cancer Specialists of North Florida /ID# 261842
Jacksonville, Florida 32256
United StatesSite Not Available
Florida Cancer Specialists /ID# 260854
Lake Mary, Florida 32746-2115
United StatesSite Not Available
Miami Cancer Institute Baptist Health South Florida /ID# 244972
Miami, Florida 33176
United StatesSite Not Available
Mount Sinai Medical Center-Miami Beach /ID# 249045
Miami Beach, Florida 33140-2948
United StatesSite Not Available
Memorial Cancer Institute (MCI) - Memorial Hospital West /ID# 248432
Pembroke Pines, Florida 33028-1023
United StatesActive - Recruiting
Memorial Hospital West /ID# 248432
Pembroke Pines, Florida 33028
United StatesSite Not Available
BRCR Medical Center Inc /ID# 262527
Tamarac, Florida 33321-2919
United StatesSite Not Available
Cleveland Clinic Florida /ID# 244532
Weston, Florida 33331-3609
United StatesSite Not Available
Emory University, Winship Cancer Institute /ID# 246056
Atlanta, Georgia 30322
United StatesSite Not Available
NW Georgia Oncology Centers /ID# 247756
Marietta, Georgia 30060
United StatesSite Not Available
Beacon Cancer Care /ID# 245018
Coeur d'Alene, Idaho 83814-2668
United StatesSite Not Available
University of Illinois - Chicago /ID# 245038
Chicago, Illinois 60607
United StatesActive - Recruiting
University of Illinois at Chicago /ID# 245038
Chicago, Illinois 60607
United StatesSite Not Available
Illinois Cancer Specialists /ID# 247655
Niles, Illinois 60714
United StatesSite Not Available
Parkview Cancer Institute /ID# 244545
Fort Wayne, Indiana 46845-1739
United StatesActive - Recruiting
Parkview Comprehensive Cancer Center /ID# 244545
Fort Wayne, Indiana 46845
United StatesSite Not Available
Indiana Blood & Marrow Transpl /ID# 244971
Indianapolis, Indiana 46237
United StatesSite Not Available
Mission Cancer and Blood /ID# 258227
Des Moines, Iowa 50314-3017
United StatesActive - Recruiting
University of Iowa Health Care /ID# 258227
Des Moines, Iowa 50314-3017
United StatesSite Not Available
Our Lady Of The Lake Regional Medical Center /ID# 255008
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Our Lady of the Lake Regional Medical Center /ID# 255008
Baton Rouge, Louisiana 70808-4375
United StatesActive - Recruiting
American Oncology Partners of Maryland /ID# 244968
Bethesda, Maryland 20817
United StatesSite Not Available
American Oncology Partners of Maryland, PA /ID# 244968
Bethesda, Maryland 20817
United StatesActive - Recruiting
Maryland Oncology Hematology /ID# 254192
Columbia, Maryland 21044-3128
United StatesSite Not Available
Beth Israel Deaconess Medical Center /ID# 248651
Boston, Massachusetts 02215-5400
United StatesSite Not Available
Massachusetts General Hospital /ID# 245239
Boston, Massachusetts 02114
United StatesSite Not Available
Tufts Medical Center /ID# 246074
Boston, Massachusetts 02111-1552
United StatesSite Not Available
Cancer & Hematology Centers of Western Michigan - East /ID# 244985
Grand Rapids, Michigan 49546-7062
United StatesSite Not Available
St. Joseph Mercy Hospital /ID# 244547
Ypsilanti, Michigan 48197-1051
United StatesActive - Recruiting
Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547
Ypsilanti, Michigan 48197-1051
United StatesSite Not Available
Hattiesburg Clinic /ID# 244980
Hattiesburg, Mississippi 39401
United StatesSite Not Available
St. Luke's Hospital - Chesterfield /ID# 247815
Chesterfield, Missouri 63017
United StatesSite Not Available
St. Luke's Hospitals /ID# 247815
Chesterfield, Missouri 63017-3406
United StatesActive - Recruiting
David C. Pratt Cancer Center /ID# 244986
Saint Louis, Missouri 63141
United StatesSite Not Available
NHO - Nebraska Hematology-Oncology /ID# 263164
Lincoln, Nebraska 68506
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003
Lebanon, New Hampshire 03756
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center /ID# 245003
Lebanon, New Hampshire 03756
United StatesActive - Recruiting
The John Theurer Cancer /ID# 262532
Hackensack, New Jersey 07601
United StatesSite Not Available
Morristown Medical Center /ID# 244973
Morristown, New Jersey 07960-6136
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey /ID# 248235
New Brunswick, New Jersey 08901
United StatesSite Not Available
University of New Mexico /ID# 252434
Albuquerque, New Mexico 87102-4517
United StatesSite Not Available
New York Cancer and Blood Specialists - Bronx /ID# 264690
Bronx, New York 10469
United StatesSite Not Available
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681
New Hyde Park, New York 11042
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai /ID# 258610
New York, New York 10029
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628
New York, New York 10065-6007
United StatesSite Not Available
New York Cancer and Blood Specialists - New York /ID# 264676
New York, New York 10028
United StatesSite Not Available
Stony Brook University Medical Center /ID# 244631
New York, New York 10021
United StatesSite Not Available
New York Cancer and Blood Specialists /ID# 259016
Port Jefferson Station, New York 11776-8060
United StatesSite Not Available
University of Rochester Cancer Center /ID# 245033
Rochester, New York 14642-0001
United StatesSite Not Available
East Carolina University - Brody School of Medicine /ID# 248989
Greenville, North Carolina 27834
United StatesSite Not Available
East Carolina University Brody School of Medicine /ID# 248989
Greenville, North Carolina 27834
United StatesActive - Recruiting
Wake Forest Univ HS /ID# 245005
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Oncology Hematology Care, Inc. /ID# 246182
Cincinnati, Ohio 45236-2725
United StatesSite Not Available
Ohio Health /ID# 260803
Columbus, Ohio 43214-3908
United StatesActive - Recruiting
OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803
Columbus, Ohio 43214-3908
United StatesSite Not Available
Dayton VA Medical Center /ID# 249114
Dayton, Ohio 45428
United StatesSite Not Available
Toledo Clinic Cancer Center - Main /ID# 246852
Toledo, Ohio 43623
United StatesSite Not Available
Toledo Clinic Cancer Center /ID# 246852
Toledo, Ohio 43623
United StatesActive - Recruiting
University of Oklahoma, Stephenson Cancer Center /ID# 244568
Oklahoma City, Oklahoma 73104-5418
United StatesSite Not Available
Willamette Valley Cancer Institute and Research Center /ID# 246410
Eugene, Oregon 97401-6043
United StatesSite Not Available
Oregon Oncology Specialists in Salem /ID# 260570
Salem, Oregon 97301-3975
United StatesSite Not Available
Lehigh Valley Hospital-Cedar Crest /ID# 244984
Allentown, Pennsylvania 18103-6202
United StatesSite Not Available
Spoknwrd Clinical Trials /ID# 265232
Easton, Pennsylvania 18045
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center /ID# 244979
Hershey, Pennsylvania 17033-2360
United StatesSite Not Available
UPMC Hillman Cancer Ctr /ID# 244571
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Reading Hospital; McGlinn Cancer Institute /ID# 259181
West Reading, Pennsylvania 19611-2143
United StatesSite Not Available
Cancer Care Associates of York /ID# 254159
York, Pennsylvania 17403
United StatesSite Not Available
Medical University of South Carolina /ID# 249968
Charleston, South Carolina 29425
United StatesSite Not Available
Prisma Health /ID# 247654
Greenville, South Carolina 29605
United StatesSite Not Available
Prisma Health Cancer Institute-Faris Road /ID# 247654
Greenville, South Carolina 29605-4255
United StatesActive - Recruiting
The West Clinic /ID# 245004
Memphis, Tennessee 38120
United StatesSite Not Available
Vanderbilt University Medical Center /ID# 260953
Nashville, Tennessee 37232
United StatesSite Not Available
Texas Oncology - Austin Midtown /ID# 247656
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology - Dallas - Worth Street /ID# 262956
Dallas, Texas 75246
United StatesSite Not Available
Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659
Dallas, Texas 75231
United StatesSite Not Available
University of Texas Southwestern Medical Center /ID# 244552
Dallas, Texas 75390-7208
United StatesSite Not Available
Texas Oncology - San Antonio Medical Center /ID# 247658
San Antonio, Texas 78240-5251
United StatesSite Not Available
Texas Oncology - Northeast Texas /ID# 247657
Tyler, Texas 75702
United StatesSite Not Available
Huntsman Cancer Institute /ID# 251446
Salt Lake City, Utah 84112
United StatesSite Not Available
Virginia Cancer Specialists - Gainesville /ID# 248760
Gainesville, Virginia 20155-3257
United StatesSite Not Available
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514
Norfolk, Virginia 23502
United StatesSite Not Available
Blue Ridge Cancer Center /ID# 260597
Roanoke, Virginia 24014-2419
United StatesSite Not Available
Northwest Medical Specialties - Tacoma /ID# 245045
Tacoma, Washington 98405
United StatesSite Not Available
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