Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma (EPCORE FL-1)
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研究单位：[1]AbbVie[2]Orange Coast Medical Center /ID# 229634 Fountain Valley, California, United States, 92708-6728[3]Marin Cancer Care /ID# 227207 Greenbrae, California, United States, 94904[4]Saddleback Memorial Medical Center /ID# 229633 Laguna Hills, California, United States, 92653-3689[5]Long Beach Memorial Medical Ct /ID# 228997 Long Beach, California, United States, 90806-1701[6]University of Southern California /ID# 227195 Los Angeles, California, United States, 90033[7]Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228619 Aurora, Colorado, United States, 80014[8]Baptist MD Anderson Cancer Center - Jacksonville /ID# 227270 Jacksonville, Florida, United States, 32207-8432[9]Emory University /ID# 227299 Atlanta, Georgia, United States, 30322-1013[10]Augusta University Georgia Cancer Center /ID# 227313 Augusta, Georgia, United States, 30912-0003[11]Northwestern University /ID# 227248 Chicago, Illinois, United States, 60611-2927[12]Southern IL Univ School of Med /ID# 229000 Springfield, Illinois, United States, 62702[13]Goshen Center for Cancer Care /ID# 227189 Goshen, Indiana, United States, 46526[14]University of Maryland School of Medicine /ID# 227191 Baltimore, Maryland, United States, 21201-1544[15]Massachusetts General Hospital /ID# 245233 Boston, Massachusetts, United States, 02114[16]UMass Chan Medical School /ID# 227323 Worcester, Massachusetts, United States, 01655[17]Henry Ford Health System /ID# 227250 Detroit, Michigan, United States, 48202[18]Mmcorc /Id# 227177 Saint Louis Park, Minnesota, United States, 55416[19]Alliance for Multispecialty Research (AMR) - Kansas City /ID# 231075 Kansas City, Missouri, United States, 64114-4859[20]Morristown Medical Center /ID# 231427 Morristown, New Jersey, United States, 07960-6136[21]Roswell Park Comprehensive Cancer Center /ID# 239128 Buffalo, New York, United States, 14263[22]NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 227322 New York, New York, United States, 10016-4744[23]Icahn School of Medicine at Mount Sinai /ID# 227181 New York, New York, United States, 10029-6504[24]Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193 New York, New York, United States, 10065-6007[25]University of Rochester Cancer Center /ID# 227870 Rochester, New York, United States, 14642-0001[26]Cape Fear Valley Medical Center /ID# 246915 Fayetteville, North Carolina, United States, 28304-3424[27]East Carolina University Brody School of Medicine /ID# 227192 Greenville, North Carolina, United States, 27834[28]The Christ Hospital /ID# 229335 Cincinnati, Ohio, United States, 45219[29]Fox Chase Cancer Center /ID# 231484 Philadelphia, Pennsylvania, United States, 19111[30]Lankenau Medical Center /ID# 228921 Wynnewood, Pennsylvania, United States, 19096[31]Medical University of South Carolina /ID# 227351 Charleston, South Carolina, United States, 29425[32]Virginia Commonwealth University Medical Center Main Hospital /ID# 227211 Richmond, Virginia, United States, 23219[33]UW, Cancer Ctr ProHealth Care /ID# 228746 Waukesha, Wisconsin, United States, 53188[34]Hospital Universitario Austral /ID# 230865 Pilar, Buenos Aires, Argentina, 1629[35]Hospital Italiano de Buenos Aires /ID# 229699 Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1199[36]Fundaleu /Id# 229700 Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1114[37]Cemic /Id# 229697 Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1431[38]Hospital Privado Univesitario /ID# 229701 Cordoba, Argentina, 5016[39]Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124 Santa Fe, Argentina, 3000[40]Royal Prince Alfred Hospital /ID# 239272 Camperdown, New South Wales, Australia, 2050[41]Nepean Hospital /ID# 239093 Kingswood, New South Wales, Australia, 2747[42]Townsville University Hospital /ID# 231124 Douglas, Queensland, Australia, 4814[43]Fiona Stanley Hospital /ID# 231122 Murdoch, Western Australia, Australia, 6150[44]Royal Perth Hospital /ID# 230456 Perth, Western Australia, Australia, 6000[45]Peninsula Private Hospital /ID# 238796 Langwarrin, Australia, 3910[46]Universitaetsklinikum St. Poelten /ID# 234015 Sankt Poelten, Niederoesterreich, Austria, 3100[47]Ordensklinikum Linz GmbH Elisabethinen /ID# 247510 Linz, Oberoesterreich, Austria, 4010[48]Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228366 Salzburg, Austria, 5020[49]Uza /Id# 228521 Edegem, Antwerpen, Belgium, 2650[50]Universitair Ziekenhuis Leuven /ID# 247780 Leuven, Vlaams-Brabant, Belgium, 3000[51]Pôle Hospitalier Jolimont /ID# 228520 La Louvière, Belgium, 7100[52]Groupe Sante CHC - Clinique du MontLegia /ID# 230415 Liege, Belgium, 4000[53]Vitaz /Id# 228525 Sint-Niklaas, Belgium, 9100[54]AZ Turnhout - Campus Sint-Elisabeth /ID# 231628 Turnhout, Belgium, 2300[55]Hospital de Clinicas da Universidade Federal do Parana /ID# 228123 Curitiba, Parana, Brazil, 80060-900[56]Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129 Jaú, Sao Paulo, Brazil, 17210-070[57]Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130 São Paulo, Sao Paulo, Brazil, 01509-900[58]Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 228706 Rio de Janeiro, Brazil, 20231-050[59]Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121 Sao Paulo, Brazil, 01323-001[60]Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182 Sao Paulo, Brazil, 04039-901[61]Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 228127 Sao Paulo, Brazil, 05403-000[62]Cross Cancer Institute /ID# 249080 Edmonton, Alberta, Canada, T6G 1Z2[63]BC Cancer - Victoria /ID# 228850 Victoria, British Columbia, Canada, V8R 6V5[64]Saint John Regional Hospital /ID# 233548 Saint John, New Brunswick, Canada, E2L 4L2[65]Victoria Hospital /ID# 229409 London, Ontario, Canada, N6A 4L6[66]CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896 Levis, Quebec, Canada, G6V 3Z1[67]CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537 Quebec City, Quebec, Canada, G1J 1Z4[68]CISSSBSL -Hopital regional de Rimouski /ID# 229894 Rimouski, Quebec, Canada, G5L 5T1[69]Saskatoon Cancer Centre /ID# 234240 Saskatoon, Saskatchewan, Canada, S7N 4H4[70]Peking University Third Hospital /ID# 230885 Beijing, Beijing, China, 100191[71]Fujian Medical University Union Hospital /ID# 233919 Fuzhou, Fujian, China, 350001[72]Sun Yat-Sen University Cancer Center /ID# 231463 Guangzhou, Guangdong, China, 510060[73]Guangdong Provincial People's Hospital /ID# 232512 Guangzhou, Guangdong, China, 510080[74]Nanfang Hospital of Southern Medical University /ID# 230383 Guangzhou, Guangdong, China, 510515[75]The Fourth Hospital of Hebei Medical University /ID# 238657 Shijiazhuang, Hebei, China, 050011河北医科大学第四医院
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.
Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).
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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
