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

Status: Recruiting
Location: See all (163) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group Performance status score of 0 to 2.

• Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.

• Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.

• Participant must meet at least 1 of the following criteria:

‣ Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.

⁃ Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.

⁃ Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

• Unable to receive CAR-T therapy due to fitness and/or comorbidity.

∙ Lymphocyte apheresis failure.

∙ Unwilling to receive CAR-T therapy.

∙ Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.

∙ Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.

• Must have measurable disease.

• Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study

Locations
United States
California
City of Hope National Medical Center /ID# 273338
RECRUITING
Duarte
Valkyrie Clinical Trials /ID# 269935
RECRUITING
Los Angeles
Colorado
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
RECRUITING
Golden
Georgia
City Of Hope - Atlanta /ID# 273092
RECRUITING
Newnan
Illinois
Rush University Medical Center /ID# 242103
RECRUITING
Chicago
City Of Hope - Chicago /ID# 274430
RECRUITING
Zion
Indiana
Northwest Cancer Center - Dyer Clinic /ID# 269787
RECRUITING
Dyer
Kansas
Cancer Center of Kansas - Wichita /ID# 270117
RECRUITING
Wichita
Kentucky
University of Kentucky Chandler Medical Center /ID# 242087
RECRUITING
Lexington
Maryland
University of Maryland, Baltimore /ID# 242216
RECRUITING
Baltimore
Michigan
Henry Ford Hospital /ID# 266446
RECRUITING
Detroit
Mississippi
Gulfport Memorial Hospital /ID# 268104
RECRUITING
Gulfport
North Carolina
East Carolina University - Brody School of Medicine /ID# 242227
RECRUITING
Greenville
New York
New York Medical College /ID# 265799
RECRUITING
Valhalla
Tennessee
Thompson Cancer Survival Ctr /ID# 242149
RECRUITING
Knoxville
Utah
Community Cancer Trials Of Utah /ID# 271715
RECRUITING
Ogden
Utah Cancer Specialists - Salt Lake City /ID# 268603
RECRUITING
Salt Lake City
Veterans Affairs Medical Center - Salt Lake City /ID# 265329
RECRUITING
Salt Lake City
Other Locations
Argentina
Fundaleu /Id# 242789
RECRUITING
Ciudad Autonoma De Buenos Aire
Instituto Alexander Fleming /ID# 263804
RECRUITING
Ciudad Autonoma De Buenos Aire
Australia
Monash Health - Monash Medical Centre /ID# 262783
RECRUITING
Clayton
Canberra Hospital /ID# 265312
RECRUITING
Garran
Royal Perth Hospital /ID# 243790
RECRUITING
Perth
Royal Prince Alfred Hospital /ID# 263242
RECRUITING
Sydney
Toowoomba Hospital /ID# 263243
RECRUITING
Toowoomba
Wollongong Hospital /ID# 244646
RECRUITING
Wollongong
Belgium
Centre Hospitalier Epicura - site d'Hornu /ID# 265148
RECRUITING
Boussu
Universitair Ziekenhuis Brussel /ID# 242574
RECRUITING
Jette
Universitair Ziekenhuis Leuven /ID# 246671
RECRUITING
Leuven
AZ-Delta /ID# 264740
RECRUITING
Roeselare
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565
RECRUITING
Yvoir
Bulgaria
UMHAT Sveti Georgi /ID# 242905
RECRUITING
Plovdiv
SHAT Hematologic Diseases /ID# 242708
RECRUITING
Sofia
UMHAT Sveti Ivan Rilski /ID# 242389
RECRUITING
Sofia
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 262761
RECRUITING
Varna
Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 262751
RECRUITING
Montreal
Chile
Fundacion Arturo Lopez Perez /ID# 242421
RECRUITING
Providencia
Bradford Hill /ID# 262795
RECRUITING
Santiago
Clinica Alemana de Santiago /ID# 244139
RECRUITING
Santiago
China
Peking University Third Hospital /ID# 242941
RECRUITING
Beijing
The First Hospital of Jilin University /ID# 242940
RECRUITING
Changchun
Fujian Province Cancer Hospital /ID# 265075
RECRUITING
Fuzhou
Guangdong Provincial Peoples Hospital /ID# 242942
RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Center /ID# 242712
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 242960
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243137
RECRUITING
Hangzhou
Zhejiang Cancer hospital /ID# 242711
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital /Id# 242961
RECRUITING
Harbin
Shandong Cancer Hospital /ID# 264036
RECRUITING
Jinan
Yunnan Province Cancer Hospital /ID# 264057
RECRUITING
Kunming
Jiangxi Provincial Cancer Hospital /ID# 242968
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University /ID# 242703
RECRUITING
Nanchang
Jiangsu Peoples Hospital /ID# 271924
RECRUITING
Nanjing
Shanghai Tongji Hospital /ID# 263952
RECRUITING
Shanghai
The First Hospital of China Medical University /ID# 242701
RECRUITING
Shenyang
The Second Hospital of Hebei Medical University /ID# 242944
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University /ID# 242939
RECRUITING
Suzhou
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 243139
RECRUITING
Tianjin
Tianjin Cancer Hospital /ID# 243940
RECRUITING
Tianjin
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 242966
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University /ID# 263951
RECRUITING
Wenzhou
Hubei Cancer Hospital /ID# 242963
RECRUITING
Wuhan
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 242702
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen /ID# 264305
RECRUITING
Xiamen
Henan Cancer Hospital /ID# 242700
RECRUITING
Zhengzhou
Croatia
Klinicki bolnicki centar Osijek /ID# 262621
RECRUITING
Osijek
Klinički Bolnički Centar Rijeka /ID# 266004
RECRUITING
Rijeka
Klinicki Bolnicki Centar (KBC) Split /ID# 262618
RECRUITING
Split
Klinicka bolnica Merkur /ID# 262619
RECRUITING
Zagreb
Klinicki bolnicki centar Sestre milosrdnice /ID# 262620
RECRUITING
Zagreb
Klinicki bolnicki centar Zagreb /ID# 262617
RECRUITING
Zagreb
France
Centre Hospitalier D'Avignon /ID# 243072
RECRUITING
Avignon
Centre Hospitalier de la Cote Basque /ID# 243065
RECRUITING
Bayonne
CHU de CAEN - Hopital de la Cote de Nacre /ID# 243075
RECRUITING
Caen
Hopital Saint Vincent de Paul /ID# 243070
RECRUITING
Lille
CHU Poitiers - La miletrie /ID# 243074
RECRUITING
Poitiers
Institut de cancérologie Strasbourg Europe (ICANS) /ID# 264068
RECRUITING
Strasbourg
CHRU Tours - Hopital Bretonneau /ID# 244580
RECRUITING
Tours
Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 242039
RECRUITING
Athens
General Hospital of Athens Laiko /ID# 262809
RECRUITING
Athens
University General Hospital Attikon /ID# 242041
RECRUITING
Athens
General University Hospital of Thessaloniki AXEPA /ID# 242038
RECRUITING
Thessaloniki
Theageneio Anticancer Hospital /ID# 242036
RECRUITING
Thessaloniki
Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 262923
RECRUITING
Budapest
Orszagos Onkologiai Intezet /ID# 242457
RECRUITING
Budapest
Semmelweis Egyetem /ID# 242455
RECRUITING
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 242451
RECRUITING
Debrecen
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 262901
RECRUITING
Győr
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 242468
RECRUITING
Nyíregyháza
Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924
RECRUITING
Pécs
Japan
Hyogo Prefectural Amagasaki General Medical Center /ID # 277258
RECRUITING
Amagasaki
University of Yamanashi Hospital /ID# 264671
RECRUITING
Chuo-shi
Kyushu University Hospital /ID# 267624
RECRUITING
Fukuoka
Fukushima Medical University Hospital /ID# 264667
RECRUITING
Fukushima
Kansai Medical University Hirakata Hospital /ID# 266018
RECRUITING
Hirakata-shi
Tokai University Hospital /ID# 265433
RECRUITING
Isehara
Kagoshima University Hospital /ID# 248259
RECRUITING
Kagoshima
Shonankamakura General Hospital /ID# 277671
RECRUITING
Kamakura
Duplicate_Saitama Cancer Center /ID# 265277
COMPLETED
Kitaadachi-gun
National Hospital Organization Shikoku Cancer Center /ID# 265977
RECRUITING
Matsuyama
Kindai University Hospital /ID# 265474
RECRUITING
Osaka Sayama-shi
Sapporo Medical University Hospital /ID# 264928
RECRUITING
Sapporo
Fujita Health University Hospital /ID# 265968
RECRUITING
Toyoake
Mexico
Centro de Quimioterapia E Investigacion Sas de Cv /Id# 263293
RECRUITING
Jalisco
Centro De Investigación Clinica Chapultepec /ID# 243959
RECRUITING
Mexico City
Netherlands
Jeroen Bosch Ziekenhuis, locatie 's-Hertogenbosch /ID# 265204
RECRUITING
's-hertogenbosch
OLVG - Locatie Oost /ID# 263355
RECRUITING
Amsterdam
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 263361
RECRUITING
Dordrecht
Medisch Centrum Leeuwarden /ID# 245501
RECRUITING
Leeuwarden
St. Antonius Ziekenhuis /ID# 245197
RECRUITING
Nieuwegein
New Zealand
North Shore Hospital /ID# 266060
RECRUITING
Auckland
Wellington Hospital /ID# 265966
RECRUITING
Wellington
Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 242436
RECRUITING
Kielce
Pratia MCM Krakow /ID# 262882
RECRUITING
Krakow
Aidport sp z o.o. /ID# 262766
RECRUITING
Poznan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 263314
RECRUITING
Warsaw
Portugal
Hospital da Luz /ID# 262965
RECRUITING
Lisbon
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 262961
RECRUITING
Porto
Unidade Local de Saude Sao Joao, EPE /ID# 262962
RECRUITING
Porto
Republic of Korea
Dong-A University Medical Center /ID# 262841
RECRUITING
Busan
Inje University - Busan Paik Hospital /ID# 262842
RECRUITING
Busan
Keimyung University Dongsan Hospital /ID# 262840
RECRUITING
Daegu
Chonnam National University Hwasun Hospital /ID# 262843
RECRUITING
Hwasun-gun
Jeonbuk National University Hospital /ID# 242958
RECRUITING
Jeonju
Seoul National University Bundang Hospital /ID# 242405
RECRUITING
Seongnam-si
Asan Medical Center /ID# 242409
RECRUITING
Seoul
Samsung Medical Center /ID# 242408
RECRUITING
Seoul
Seoul National University Hospital /ID# 242407
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242406
RECRUITING
Seoul
Ulsan University Hospital /ID# 242956
RECRUITING
Ulsan
Romania
Fundeni Clinical Institute /ID# 266734
RECRUITING
Bucharest
Spitalul Clinic Coltea /ID# 243694
RECRUITING
Bucharest
Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 243753
RECRUITING
Cluj-napoca
Institutul Regional de Oncologie /ID# 244367
RECRUITING
Iași
Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 263053
RECRUITING
Belgrade
Clinical Hospital Center Zvezdara /ID# 263059
RECRUITING
Belgrade
Institute for Oncology and Radiology of Serbia /ID# 263055
RECRUITING
Belgrade
University Clinical Center Serbia /ID# 263057
RECRUITING
Belgrade
Institute for Oncology of Vojvodina /ID# 263052
RECRUITING
Kamenitz
University Clinical Center Nis /ID# 263701
RECRUITING
Niš
University Clinical Center Vojvodina /ID# 264138
RECRUITING
Novi Sad
Singapore
National Cancer Centre Singapore /ID# 267015
RECRUITING
Singapore
National University Hospital /ID# 264016
RECRUITING
Singapore
Tan Tock Seng Hospital /ID# 266061
RECRUITING
Singapore
South Africa
Constantiaberg Haematology /ID# 273041
RECRUITING
Cape Town
Wits Clinical Research /ID# 264656
RECRUITING
Johannesburg
Haemalife Inc. /ID# 262719
RECRUITING
Kuils River
Alberts Cellular Therapy /ID# 262720
RECRUITING
Pretoria
Taiwan
China Medical University Hospital /ID# 242931
RECRUITING
Taichung
Taichung Veterans General Hospital /ID# 242937
RECRUITING
Taichung
National Cheng Kung University Hospital /ID# 243301
RECRUITING
Tainan City
National Taiwan University Hospital /ID# 243300
RECRUITING
Taipei City
Turkey
Ankara Universitesi Fakultesi /ID# 242410
RECRUITING
Ankara
Adnan Menderes University /ID# 242418
RECRUITING
Aydin
Trakya University Medical Facu /ID# 242419
RECRUITING
Edirne, Istanbul
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 242414
RECRUITING
Istanbul
Ege University Medical Faculty /ID# 242417
RECRUITING
Izmir
Ondokuz mayis University Facul /ID# 242412
RECRUITING
Samsun
Istanbul Florence Nightingale Hospital /ID# 271544
RECRUITING
Şişli
Karadeniz Technical University Farabi Hospital /ID# 264694
RECRUITING
Trabzon
United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 242923
RECRUITING
Newcastle Upon Tyne
Nottingham City Hospital /ID# 265129
RECRUITING
Nottingham
Royal Cornwall Hospital /ID# 265130
RECRUITING
Truro
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2028-01
Participants
Target number of participants: 360
Treatments
Experimental: Arm A: Epcoritamab Plus Lenalidomide (E-Len)
Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).
Experimental: Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)
Experimental: Arm C: Epcoritamab
Participants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).
Sponsors
Collaborators: AbbVie
Leads: Genmab

This content was sourced from clinicaltrials.gov

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