Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Start Date
6/18/2024
Completion Date
12/1/2032
Summary
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
cemacabtagene ansegedleucel
Fludarabine
Cyclophosphamide
Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
Conditions
Locations
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913
United States
Alta Bates Summit Medical Center
Berkeley, California 94704
United States
City of Hope
Duarte, California 91010
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
University of California, Los Angeles
Los Angeles, California 90095
United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
University of California, San Diego
San Diego, California 92037
United States
University of California, San Francisco
San Francisco, California 94143
United States
Rocky Mountain Cancer Centers
Denver, Colorado 80218
United States
Medical Oncology Hematology Consultants
Newark, Delaware 19713
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United States
Advent Health Cancer Institute
Orlando, Florida 32804
United States
Orlando Health Cancer Institute
Orlando, Florida 32806
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Augusta University Georgia Cancer Center
Augusta, Georgia 30912
United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
United States
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana 46237
United States
The University of Kansas Hospital
Kansas City, Kansas 66205
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
University of Louisville Health Brown Cancer Center
Louisville, Kentucky 40202
United States
Norton Cancer Institute
Louisville, Kentucky 40207
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United States
The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri 65212
United States
MidAmerica Cancer Care
Kansas City, Missouri 64132
United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110
United States
Astera Cancer Care
East Brunswick, New Jersey 08816
United States
John Theurer Cancer Center
Hackensack, New Jersey 07601
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Columbia University Irving Medical Center and New York-Presbyterian Hospital
New York, New York 10032
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
Novant Health Cancer Institute- Hematology
Charlotte, North Carolina 28204
United States
Duke Blood Cancer Center
Durham, North Carolina 27705
United States
Oncology Hematology Care - Kenwood
Cincinnati, Ohio 45236
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Oncology Associates of Oregon
Eugene, Oregon 97401
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Texas Oncology - Central South
Austin, Texas 78705
United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas 75246
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Texas Transplant Institute
San Antonio, Texas 78229
United States
Texas Oncology - Tyler
Tyler, Texas 75702
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
Intermountain Health LDS Hospital
Salt Lake City, Utah 84142
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Icon Cancer Centre Wesley
Auchenflower, Queensland 4066
Australia
Royal Hobart Hospital
Hobart, Tasmania 7000
Australia
Monash Health
Clayton, Victoria 3168
Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
Hollywood Private Hospital
Nedlands, Western Australia 6009
Australia
Arthur JE Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia B3H 2Y9
Canada
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario M5G 1Z5
Canada
Centre Integre Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / installation Hopital Maisonneuve-Rosemont
Montreal, Quebec H1T 2M4
Canada
CHUM - University of Montreal Hospital Centre
Montreal, Quebec H2X 0A9
Canada
Hopital de'L'Enfant-Jesus
Québec, Quebec G1R 2J6
Canada
Pusan National University Hospital
Seogu, Busan South Korea
South Korea
National Cancer Center
Goyang-si, Gyeonggi-do 10408
South Korea
Chonnam National University, Hwasun Hospital
Hwasun, Jeollanam-do 58128
South Korea
Seoul National University
Seoul, Seoul 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul 03722
South Korea
Asan Medical Center
Seoul, Seoul 05505
South Korea
Samsung Medical Center
Seoul, Seoul 06351
South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Seoul 07345
South Korea