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A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Genmab
Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world. Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC 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.
Official title: A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
379
Start Date
2024-08-13
Completion Date
2028-03
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Subcutaneous Injection
Rituximab
Intravenous (IV) Infusion
Lenalidomide
Oral Capsule
Oxaliplatin
IV Infusion
Gemcitabine
IV Infusion
Locations (176)
City of Hope National Medical Center /ID# 273338
Duarte, California, United States
Valkyrie Clinical Trials /ID# 269935
Los Angeles, California, United States
Desert Regional Medical Center /ID# 272437
Palm Springs, California, United States
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
Golden, Colorado, United States
City Of Hope - Atlanta. /ID# 273092
Newnan, Georgia, United States
Rush University Medical Center /ID# 242103
Chicago, Illinois, United States
City Of Hope - Chicago /ID# 274430
Zion, Illinois, United States
Northwest Cancer Center - Dyer Clinic /ID# 269787
Dyer, Indiana, United States
Cancer Center of Kansas - Wichita /ID# 270117
Wichita, Kansas, United States
University of Kentucky Chandler Medical Center. /ID# 242087
Lexington, Kentucky, United States
University of Maryland, Baltimore /ID# 242216
Baltimore, Maryland, United States
Henry Ford Hospital /ID# 266446
Detroit, Michigan, United States
Gulfport Memorial Hospital /ID# 268104
Gulfport, Mississippi, United States
New York Medical College /ID# 265799
Valhalla, New York, United States
East Carolina University - Brody School of Medicine /ID# 242227
Greenville, North Carolina, United States
Thompson Cancer Survival Ctr /ID# 242149
Knoxville, Tennessee, United States
Community Cancer Trials Of Utah /ID# 271715
Ogden, Utah, United States
Utah Cancer Specialists - Salt Lake City /ID# 268603
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City /ID# 265329
Salt Lake City, Utah, United States
Hospital Universitario Austral /ID# 242791
Pilar, Buenos Aires, Argentina
Fundaleu /Id# 242789
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Instituto Alexander Fleming /ID# 263804
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Canberra Hospital /ID# 265312
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital /ID# 263242
Sydney, New South Wales, Australia
Wollongong Hospital /ID# 244646
Wollongong, New South Wales, Australia
Toowoomba Hospital /ID# 263243
Toowoomba, Queensland, Australia
Monash Health - Monash Medical Centre /ID# 262783
Clayton, Victoria, Australia
Royal Perth Hospital /ID# 243790
Perth, Western Australia, Australia
Universitair Ziekenhuis Brussel /ID# 242574
Jette, Brussels Capital, Belgium
Centre Hospitalier Epicura - Hornu /ID# 265148
Boussu, Hainaut, Belgium
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565
Yvoir, Namur, Belgium
Universitair Ziekenhuis Leuven /ID# 246671
Leuven, Vlaams-Brabant, Belgium
AZ-Delta. /ID# 264740
Roeselare, West-Vlaanderen, Belgium
Hospital Sao Rafael /ID# 262949
Salvador, Estado de Bahia, Brazil
Hospital Erasto Gaertner /ID# 264049
Curitiba, Puerto Rico, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 264045
Ribeirão Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz /ID# 247418
São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 263944
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 242425
São Paulo, Brazil
UMHAT Sveti Georgi /ID# 242905
Plovdiv, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 242389
Sofia, Bulgaria
SHAT Hematologic Diseases /ID# 242708
Sofia, Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 262761
Varna, Bulgaria
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 262751
Montreal, Quebec, Canada
Fundacion Arturo Lopez Perez /ID# 242421
Providencia, Santiago Metropolitan, Chile
Bradford Hill /ID# 262795
Santiago, Santiago Metropolitan, Chile
Clinica Alemana de Santiago /ID# 244139
Santiago, Chile
Peking University Third Hospital /ID# 242941
Beijing, Beijing Municipality, China
Fujian Province Cancer Hospital /ID# 265075
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen /ID# 264305
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 242712
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital /ID# 242942
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University /ID# 242944
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital /Id# 242961
Harbin, Heilongjiang, China
Henan Cancer Hospital /ID# 242700
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 242702
Wuhan, Hubei, China
Hubei Cancer Hospital /ID# 242963
Wuhan, Hubei, China
Jiangsu Peoples Hospital /ID# 271924
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University /ID# 242939
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 242703
Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital /ID# 242968
Nanchang, Jiangxi, China
The First Hospital of Jilin University /ID# 242940
Changchun, Jilin, China
First Affiliated Hospital of China Medical University /ID# 242701
Shenyang, Liaoning, China
Shandong Cancer Hospital /ID# 264036
Jinan, Shandong, China
Shanghai Tongji Hospital /ID# 263952
Shanghai, Shanghai Municipality, China
Tianjin Cancer Hospital /ID# 243940
Tianjin, Tianjin Municipality, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 243139
Tianjin, Tianjin Municipality, China
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 242966
Ürümqi, Xinjiang, China
Yunnan Province Cancer Hospital /ID# 264057
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 242960
Hangzhou, Zhejiang, China
Zhejiang Cancer hospital /ID# 242711
Hangzhou, Zhejiang, China
Second Affiliated Hospital, Zhejiang University - Binjiang Campus /ID# 243137
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 263951
Wenzhou, Zhejiang, China
Klinicka bolnica Merkur /ID# 262619
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 262620
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 262617
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Osijek /ID# 262621
Osijek, County of Osijek-Baranja, Croatia
Klinički Bolnički Centar Rijeka /ID# 266004
Rijeka, Primorje-Gorski Kotar County, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 262618
Split, Split-Dalmatia County, Croatia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 264071
Hradec Králové, Hradec Kralove, Czechia
Fakultni nemocnice Motol a Homolka /ID# 272378
Prague, Praha 5, Czechia
Fakultni nemocnice Olomouc /ID# 262832
Olomouc, Czechia
Les Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre /ID# 264068
Strasbourg, Alsace, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 243075
Caen, Calvados, France
CHRU Tours - Hopital Bretonneau /ID# 244580
Tours, Indre-et-Loire, France
Centre Hospitalier D'Avignon /ID# 243072
Avignon, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Cote Basque /ID# 243065
Bayonne, Pyrenees-Atlantiques, France
CHU Poitiers - La miletrie /ID# 243074
Poitiers, Vienne, France
Hopital Saint Vincent de Paul /ID# 243070
Lille, France
General Hospital of Athens Laiko /ID# 262809
Athens, Attica, Greece
University General Hospital Attikon /ID# 242041
Athens, Attica, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 242039
Athens, Greece
General University Hospital of Thessaloniki AXEPA /ID# 242038
Thessaloniki, Greece
Theageneio Anticancer Hospital /ID# 242036
Thessaloniki, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924
Pécs, Baranya, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 262901
Győr, Győr-Moson-Sopron, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 242451
Debrecen, Hajdú-Bihar, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 242468
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem /ID# 242455
Budapest, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 262923
Budapest, Hungary