A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
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研究单位：[1]AbbVie[2]University of Arizona Cancer Center - North Campus /ID# 227463 Tucson, Arizona, United States, 85719-1478[3]University of Arkansas for Medical Sciences /ID# 225703 Little Rock, Arkansas, United States, 72205[4]Sutter Health Alta Bates Summit Medical Center /ID# 229427 Berkeley, California, United States, 94705-2067[5]Orange Coast Medical Center /ID# 229632 Fountain Valley, California, United States, 92708-6728[6]Marin Cancer Care /ID# 226647 Greenbrae, California, United States, 94904[7]Saddleback Memorial Medical Center /ID# 229631 Laguna Hills, California, United States, 92653-3689[8]Long Beach Memorial Medical Ct /ID# 228996 Long Beach, California, United States, 90806-1701[9]University of Southern California /ID# 225443 Los Angeles, California, United States, 90033[10]Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 Aurora, Colorado, United States, 80014[11]UCHSC Anschultz Cancer Pavilion /ID# 226040 Aurora, Colorado, United States, 80045-2517[12]Yale University /ID# 226022 New Haven, Connecticut, United States, 06510[13]Christiana Care Health Service /ID# 228266 Newark, Delaware, United States, 19713[14]Holy Cross Hospital /ID# 228539 Fort Lauderdale, Florida, United States, 33308[15]Baptist MD Anderson Cancer Center - Jacksonville /ID# 227040 Jacksonville, Florida, United States, 32207-8432[16]Orlando Health /ID# 232626 Orlando, Florida, United States, 32806-2134[17]Cleveland Clinic Florida /ID# 229377 Weston, Florida, United States, 33331-3609[18]Emory University /ID# 226052 Atlanta, Georgia, United States, 30322-1013[19]Augusta University Georgia Cancer Center /ID# 227131 Augusta, Georgia, United States, 30912-0003[20]Straub Medical Center /ID# 229464 Honolulu, Hawaii, United States, 96813-3097[21]Rush University Medical Center /ID# 225453 Chicago, Illinois, United States, 60612[22]Loyola University Medical Ctr /ID# 227029 Maywood, Illinois, United States, 60153[23]Southern IL Univ School of Med /ID# 228999 Springfield, Illinois, United States, 62702[24]Midwestern Regional CTC /ID# 229840 Zion, Illinois, United States, 60099[25]Parkview Cancer Institute /ID# 227026 Fort Wayne, Indiana, United States, 46845-1739[26]Goshen Center for Cancer Care /ID# 225534 Goshen, Indiana, United States, 46526[27]Norton Cancer Institute - St Matthews /ID# 225420 Louisville, Kentucky, United States, 40207[28]Ochsner Clinic Foundation-New Orleans /ID# 226148 New Orleans, Louisiana, United States, 70121[29]University of Maryland School of Medicine /ID# 225421 Baltimore, Maryland, United States, 21201-1544[30]Johns Hopkins University /ID# 225369 Baltimore, Maryland, United States, 21287[31]Walter Reed National Military Medical Center /ID# 231016 Bethesda, Maryland, United States, 20889-0004[32]Dana-Farber Cancer Institute /ID# 225506 Boston, Massachusetts, United States, 02215[33]UMass Chan Medical School /ID# 226939 Worcester, Massachusetts, United States, 01655[34]University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462 Ann Arbor, Michigan, United States, 48109[35]St. Joseph Mercy Hospital /ID# 228206 Ypsilanti, Michigan, United States, 48197-1051[36]Essentia Health DuLuth Clinic /ID# 228407 Duluth, Minnesota, United States, 55805[37]Mmcorc /Id# 226680 Saint Louis Park, Minnesota, United States, 55416[38]University of Mississippi Medical Center /ID# 228045 Jackson, Mississippi, United States, 39216-4500[39]Bozeman Health Cancer Center /ID# 229368 Bozeman, Montana, United States, 59715[40]NJ Hematology Oncology Association /ID# 228058 Brick, New Jersey, United States, 08724[41]Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654 East Brunswick, New Jersey, United States, 08816[42]Morristown Medical Center /ID# 239457 Morristown, New Jersey, United States, 07960-6136[43]Saint Peter's University Hospital /ID# 229471 New Brunswick, New Jersey, United States, 08901-1766[44]The Valley Hospital /ID# 229331 Paramus, New Jersey, United States, 07652[45]Roswell Park Comprehensive Cancer Center /ID# 239127 Buffalo, New York, United States, 14263[46]NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141 New York, New York, United States, 10016-4744[47]Icahn School of Medicine at Mount Sinai /ID# 225370 New York, New York, United States, 10029-6504[48]Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379 New York, New York, United States, 10065-6007[49]Novant Health Presbyterian Medical Center /ID# 227753 Charlotte, North Carolina, United States, 28204[50]East Carolina University Brody School of Medicine /ID# 225992 Greenville, North Carolina, United States, 27834[51]Novant Health Forsyth Medical Center /ID# 228339 Winston-Salem, North Carolina, United States, 27103[52]Gabrail Cancer Center Research /ID# 226659 Canton, Ohio, United States, 44718[53]The Christ Hospital /ID# 229334 Cincinnati, Ohio, United States, 45219[54]University of Cincinnati /ID# 225374 Cincinnati, Ohio, United States, 45267[55]University of Oklahoma, Stephenson Cancer Center /ID# 225556 Oklahoma City, Oklahoma, United States, 73104-5418[56]Kaiser Permanente - Northwest /ID# 225488 Portland, Oregon, United States, 97227[57]Thomas Jefferson University /ID# 225623 Philadelphia, Pennsylvania, United States, 19107-4414[58]UPMC Hillman Cancer Ctr /ID# 225423 Pittsburgh, Pennsylvania, United States, 15232[59]Lankenau Medical Center /ID# 228918 Wynnewood, Pennsylvania, United States, 19096[60]Medical University of South Carolina /ID# 225427 Charleston, South Carolina, United States, 29425[61]Gibbs Cancer Center & Research /ID# 229372 Spartanburg, South Carolina, United States, 29303-3040[62]Thompson Cancer Survival Ctr /ID# 227123 Knoxville, Tennessee, United States, 37916[63]University of Texas Southwestern Medical Center /ID# 225492 Dallas, Texas, United States, 75390-7208[64]Millennium Research & Clinical Development /ID# 228284 Kingwood, Texas, United States, 77339-6008[65]Joe Arrington Cancer Research /ID# 227217 Lubbock, Texas, United States, 79410[66]Intermountain Medical Center /ID# 231184 Murray, Utah, United States, 84107-5701[67]University of Virginia Cancer Center - West Complex /ID# 225433 Charlottesville, Virginia, United States, 22903-3363[68]Virginia Commonwealth University Medical Center Main Hospital /ID# 225796 Richmond, Virginia, United States, 23219[69]Swedish Cancer Institute - Edmonds /ID# 226845 Seattle, Washington, United States, 98104[70]University of Washington /ID# 225581 Seattle, Washington, United States, 98109[71]Multicare Institute for Research and Innovation /ID# 225432 Tacoma, Washington, United States, 98405[72]UW, Cancer Ctr ProHealth Care /ID# 228741 Waukesha, Wisconsin, United States, 53188[73]Instituto FIDES /ID# 231592 La Plata, Buenos Aires, Argentina, 1900[74]Hospital Italiano de Buenos Aires /ID# 228270 Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1199[75]Instituto Alexander Fleming /ID# 239473 Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1426[76]Cemic /Id# 228264 Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431[77]Hospital Privado Univesitario /ID# 228778 Cordoba, Argentina, 5016[78]Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 238730 Santa Fe, Argentina, 3000[79]Liverpool Hospital /ID# 230072 Liverpool, New South Wales, Australia, 2170[80]Royal Adelaide Hospital /ID# 225683 Adelaide, South Australia, Australia, 5000[81]Bendigo Health /ID# 225676 Bendigo, Victoria, Australia, 3550[82]Austin Health /ID# 225716 Heidelberg, Victoria, Australia, 3084[83]Alfred Health /ID# 225999 Melbourne, Victoria, Australia, 3004[84]Perth Blood Institute Ltd /ID# 225679 Nedlands, Western Australia, Australia, 6009[85]Royal Perth Hospital /ID# 226583 Perth, Western Australia, Australia, 6000[86]Medizinische Universitaet Innsbruck /ID# 228364 Innsbruck, Tirol, Austria, 6020[87]Klinik Ottakring /ID# 243941 Vienna, Wien, Austria, 1160[88]Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360 Salzburg, Austria, 5020[89]Uza /Id# 227095 Edegem, Antwerpen, Belgium, 2650[90]CHU UCL Namur - site Godinne /ID# 225742 Godinne, Namur, Belgium, 5530[91]UZ Gent /ID# 250031 Gent, Oost-Vlaanderen, Belgium, 9000[92]Universitair Ziekenhuis Leuven /ID# 225951 Leuven, Vlaams-Brabant, Belgium, 3000[93]Institut Jules Bordet /ID# 225954 Anderlecht, Belgium, 1070[94]ZNA Middelheim /ID# 225741 Antwerp, Belgium, 2020[95]AZ Sint-Jan Brugge /ID# 225735 Brugge, Belgium, 8000[96]Pôle Hospitalier Jolimont /ID# 225738 La Louvière, Belgium, 7100[97]Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 225952 Liege, Belgium, 4000[98]AZ-Delta /ID# 225736 Roeselare, Belgium, 8800[99]AZ Nikolaas /ID# 226153 Sint-Niklaas, Belgium, 9100[100]Hospital de Clinicas da Universidade Federal do Parana /ID# 226027 Curitiba, Parana, Brazil, 80060-900[101]Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065 Jaú, Sao Paulo, Brazil, 17210-070[102]Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809 São Paulo, Sao Paulo, Brazil, 01509-900[103]Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 226026 Rio de Janeiro, Brazil, 20231-050[104]Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023 Sao Paulo, Brazil, 01323-001[105]Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226048 Sao Paulo, Brazil, 05403-000[106]UMHAT Sveti Georgi /ID# 245780 Plovdiv, Bulgaria, 4002[107]Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616 Sofia, Bulgaria, 1407[108]UMHAT Sveti Ivan Rilski /ID# 244615 Sofia, Bulgaria, 1431[109]SHAT Hematologic Diseases /ID# 250102 Sofia, Bulgaria, 1756[110]Tom Baker Cancer Centre /ID# 226077 Calgary, Alberta, Canada, T2N 4N2[111]BC Cancer - Victoria /ID# 250741 Victoria, British Columbia, Canada, V8R 6V5[112]Saint John Regional Hospital /ID# 233547 Saint John, New Brunswick, Canada, E2L 4L2[113]Princess Margaret Cancer Centre /ID# 226080 Toronto, Ontario, Canada, M5G 2M9[114]CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229897 Levis, Quebec, Canada, G6V 3Z1[115]CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 233509 Montreal, Quebec, Canada, H4J 1C5[116]CHUQ- Hôpital de l'Enfant-Jesus /ID# 226074 Quebec City, Quebec, Canada, G1J 1Z4[117]CISSSBSL -Hopital regional de Rimouski /ID# 229895 Rimouski, Quebec, Canada, G5L 5T1[118]Saskatoon Cancer Centre /ID# 226082 Saskatoon, Saskatchewan, Canada, S7N 4H4[119]Beijing Cancer Hospital /ID# 229819 Beijing, Beijing, China, 100142[120]Peking University Third Hospital /ID# 230975 Beijing, Beijing, China, 100191[121]Fujian Provincial Cancer Hospital /ID# 238430 Fuzhou, Fujian, China, 350014[122]The First Affiliated Hospital of Xiamen University /ID# 238426 Xiamen, Fujian, China, 361003[123]Sun Yat-Sen University Cancer Center /ID# 238371 Guangzhou, Guangdong, China, 510060[124]Guangdong Provincial People's Hospital /ID# 230945 Guangzhou, Guangdong, China, 510080[125]Nanfang Hospital of Southern Medical University /ID# 238436 Guangzhou, Guangdong, China, 510515[126]The Fourth Hospital of Hebei Medical University /ID# 238656 Shijiazhuang, Hebei, China, 050011河北医科大学第四医院
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.
In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-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.
