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) (EPCORE DLBCL-2)

April 8, 2024 updated by: AbbVie

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

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.

Study Overview

Status

Recruiting

Conditions

Diffuse Large B-Cell Lymphoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Australia
- New South Wales
  - Liverpool, New South Wales, Australia, 2170
    - Recruiting
    - Liverpool Hospital /ID# 230072
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Recruiting
    - Royal Adelaide Hospital /ID# 225683
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Monash Medical Centre /ID# 225680
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Austin Health /ID# 225716
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - Alfred Health /ID# 225999
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Recruiting
    - Perth Blood Institute Ltd /ID# 225679
  - Nedlands, Western Australia, Australia, 6009
    - Recruiting
    - Hollywood Private Hospital /ID# 251837
  - Perth, Western Australia, Australia, 6000
    - Recruiting
    - Royal Perth Hospital /ID# 226583
Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360
- Niederoesterreich
  - Sankt Poelten, Niederoesterreich, Austria, 3100
    - Recruiting
    - Universitaetsklinikum St. Poelten /ID# 234016
- Wien
  - Vienna, Wien, Austria, 1160
    - Recruiting
    - Klinik Ottakring /ID# 243941
  - Vienna, Wien, Austria, 1090
    - Recruiting
    - Medizinische Universitaet Wien /ID# 252095
Belgium
- - Anderlecht, Belgium, 1070
    - Recruiting
    - Institut Jules Bordet /ID# 225954
  - Antwerp, Belgium, 2020
    - Recruiting
    - ZNA Middelheim /ID# 225741
  - Brugge, Belgium, 8000
    - Recruiting
    - AZ Sint-Jan Brugge /ID# 225735
- Bruxelles-Capitale
  - Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
    - Recruiting
    - UCL Saint-Luc /ID# 225737
- Hainaut
  - La Louvière, Hainaut, Belgium, 7100
    - Recruiting
    - Hospital La Louviere Site Jolimont - Helora /ID# 225738
- Liege
  - Liège, Liege, Belgium, 4000
    - Recruiting
    - CHU de Liège /ID# 225952
- Namur
  - Godinne, Namur, Belgium, 5530
    - Recruiting
    - CHU UCL Namur - site Godinne /ID# 225742
- Oost-Vlaanderen
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent /ID# 250031
  - Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    - Recruiting
    - Vitaz /Id# 226153
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Recruiting
    - Universitair Ziekenhuis Leuven /ID# 225951
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - Recruiting
    - AZ-Delta /ID# 225736
Brazil
- - Sao Paulo, Brazil, 01323-001
    - Recruiting
    - Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023
  - Sao Paulo, Brazil, 01323-020
    - Recruiting
    - Hospital Alemao Oswaldo Cruz /ID# 252833
  - Sao Paulo, Brazil, 05403-000
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048
- Parana
  - Curitiba, Parana, Brazil, 80060-900
    - Recruiting
    - Hospital de Clinicas da Universidade Federal do Parana /ID# 226027
- Sao Paulo
  - Jaú, Sao Paulo, Brazil, 17210-070
    - Recruiting
    - Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065
  - São Paulo, Sao Paulo, Brazil, 01509-900
    - Recruiting
    - Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809
  - São Paulo, Sao Paulo, Brazil, 05652-900
    - Recruiting
    - Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832
Bulgaria
- - Plovdiv, Bulgaria, 4002
    - Recruiting
    - UMHAT Sveti Georgi /ID# 245780
  - Sofia, Bulgaria, 1431
    - Recruiting
    - UMHAT Sveti Ivan Rilski /ID# 244615
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616
  - Sofia, Bulgaria, 1756
    - Recruiting
    - SHAT Hematologic Diseases /ID# 250102
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Recruiting
    - Tom Baker Cancer Centre /ID# 226077
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1L3
    - Recruiting
    - BC Cancer - Vancouver /ID# 230573
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - William Osler Health System /ID# 250973
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Recruiting
    - Saskatoon Cancer Centre /ID# 226082
China
- Beijing
  - Beijing, Beijing, China, 100142
    - Recruiting
    - Beijing Cancer Hospital /ID# 229819
  - Beijing, Beijing, China, 100191
    - Recruiting
    - Peking University Third Hospital /ID# 230975
  - Beijing, Beijing, China, 100071
    - Recruiting
    - The Fifth Medical Center of PLA General Hospital /ID# 230941
- Fujian
  - Fuzhou, Fujian, China, 350014
    - Recruiting
    - Fujian Provincial Cancer Hospital /ID# 238430
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Recruiting
    - Guangdong Provincial People's Hospital /ID# 230945
  - Guangzhou, Guangdong, China, 510515
    - Recruiting
    - Nanfang Hospital of Southern Medical University /ID# 238436
  - Guangzhou, Guangdong, China, 510060
    - Recruiting
    - Sun Yat-Sen University Cancer Center /ID# 238371
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Recruiting
    - Harbin Medical University Cancer Hospital /Id# 241755
- Hubei
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152
  - Wuhan, Hubei, China, 430079
    - Recruiting
    - Hubei Cancer Hospital /ID# 232256
- Jiangsu
  - Suzhou, Jiangsu, China, 215006
    - Recruiting
    - The First Affiliated Hospital of Soochow University /ID# 232569
  - Xuzhou, Jiangsu, China, 221006
    - Recruiting
    - The Affiliated Hospital of Xuzhou Medical College /ID# 233174
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - The First Affiliated Hospital of Nanchang University /ID# 230399
  - Nanchang, Jiangxi, China, 330029
    - Recruiting
    - Jiangxi Provincial Cancer Hospital /ID# 233379
- Jilin
  - Changchun, Jilin, China, 130021
    - Recruiting
    - The First Hospital of Jilin University /ID# 239618
- Liaoning
  - Shenyang, Liaoning, China, 110001
    - Recruiting
    - The First Hospital of China Medical University /ID# 233201
- Shandong
  - Jinan, Shandong, China, 251601
    - Recruiting
    - Shandong Cancer Hospital /ID# 233200
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Recruiting
    - Fudan University Cancer Hospital /ID# 251516
- Tianjin
  - Tianjin, Tianjin, China, 300020
    - Recruiting
    - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259904
    - Contact:
      
      Site Coordinator
      
      Phone Number: 022-23909999
  - Tianjin, Tianjin, China, 300000
    - Recruiting
    - Tianjin Cancer Hospital /ID# 230974
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Recruiting
    - Zhejiang Cancer hospital /ID# 231388
  - Hangzhou, Zhejiang, China, 310003
    - Recruiting
    - The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387
  - Hangzhou, Zhejiang, China, 310009
    - Recruiting
    - The second affiliated hospital of Zhejiang University school of medicine /ID# 231249
Croatia
- - Slavonski Brod, Croatia, 35000
    - Recruiting
    - Opca bolnica Dr. Josip Bencevic /ID# 251812
- Grad Zagreb
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Dubrava /ID# 251809
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Recruiting
    - Klinicka bolnica Merkur /ID# 252481
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Recruiting
    - Klinicki bolnicki centar Zagreb /ID# 250709
- Primorsko-goranska Zupanija
  - Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
    - Recruiting
    - Klinicki bolnicki centar Rijeka /ID# 251811
- Splitsko-dalmatinska Zupanija
  - Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
    - Active, not recruiting
    - Klinicki Bolnicki Centar (KBC) Split - Firule /ID# 250729
Czechia
- - Brno, Czechia, 613 00
    - Recruiting
    - Fakultni nemocnice Brno /ID# 225953
  - Hradec Kralove, Czechia, 500 05
    - Recruiting
    - Fakultni nemocnice Hradec Kralove /ID# 225955
  - Ostrava, Czechia, 708 52
    - Recruiting
    - Fakultni Nemocnice Ostrava /ID# 225957
  - Prague, Czechia, 150 00
    - Recruiting
    - Duplicate_Fakultni Nemocnice v Motole /ID# 225958
  - Praha, Czechia, 128 08
    - Recruiting
    - Vseobecna fakultni nemocnice v Praze /ID# 225396
  - Praha, Czechia, 100 34
    - Recruiting
    - Fakultni nemocnice Kralovske Vinohrady /ID# 225956
Denmark
- Hovedstaden
  - Copenhagen Ø, Hovedstaden, Denmark, 2100
    - Recruiting
    - Rigshospitalet /ID# 226576
- Midtjylland
  - Aarhus, Midtjylland, Denmark, 8200
    - Recruiting
    - Aarhus Universitetshospital - Skejby /ID# 226594
- Sjælland
  - Roskilde, Sjælland, Denmark, 4000
    - Recruiting
    - Roskilde Sygehus /ID# 226597
- Syddanmark
  - Odense C, Syddanmark, Denmark, 5000
    - Recruiting
    - Odense University Hospital /ID# 226593
  - Vejle, Syddanmark, Denmark, 7100
    - Recruiting
    - Sygehus Lillebalt, Vejle /ID# 226592
France
- - Angers, France, 49933
    - Recruiting
    - Chu Angers /Id# 245931
  - Caen, France, 14033
    - Recruiting
    - CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582
  - Créteil, France, 94010
    - Recruiting
    - Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 226560
  - La Roche Sur Yon, France, 85000
    - Recruiting
    - CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899
  - La Tronche, France, 38700
    - Recruiting
    - CHU Grenoble - Hopital Michallon /ID# 226128
  - Paris, France, 75010
    - Recruiting
    - AP-HP - Hopital Saint-Louis /ID# 226126
  - Rouen, France, 76038
    - Recruiting
    - Centre Henri Becquerel /ID# 226103
  - Saint-cloud, France, 92210
    - Recruiting
    - Institut Curie - site CLCC René Huguenin /ID# 253519
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06200
    - Recruiting
    - CHU de Nice - Hôpital Archet 1 /ID# 226127
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, France, 13009
    - Recruiting
    - Institut Paoli-Calmettes /ID# 226557
- Bretagne
  - Rennes, Bretagne, France, 35000
    - Recruiting
    - CHU de Rennes - PONTCHAILLOU /ID# 228207
- Cote-d Or
  - Dijon, Cote-d Or, France, 21000
    - Recruiting
    - CHU Dijon /ID# 238345
- Franche-Comte
  - Limoges CEDEX 1, Franche-Comte, France, 87042
    - Recruiting
    - CHU Limoges - Dupuytren 1 /ID# 234235
- Herault
  - Montpellier Cedex 5, Herault, France, 34295
    - Recruiting
    - CHU Montpellier - Hôpital Saint Eloi /ID# 228191
- Meurthe-et-Moselle
  - Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
    - Recruiting
    - CHRU Nancy - Hopitaux de Brabois /ID# 226102
- Nord
  - Lille, Nord, France, 59037
    - Recruiting
    - CHRU Lille - Hopital Claude Huriez /ID# 226101
- Pays-de-la-Loire
  - Nantes, Pays-de-la-Loire, France, 44000
    - Recruiting
    - CHU de Nantes, Hotel Dieu -HME /ID# 226125
- Pyrenees-Atlantiques
  - Bayonne, Pyrenees-Atlantiques, France, 64100
    - Recruiting
    - Centre Hospitalier de la Cote Basque /ID# 249143
- Rhone
  - Pierre Benite CEDEX, Rhone, France, 69495
    - Recruiting
    - HCL - Hopital Lyon Sud /ID# 227086
- Somme
  - Amiens CEDEX 1, Somme, France, 80054
    - Recruiting
    - CHU Amiens-Picardie Site Sud /ID# 238347
- Vienne
  - Poitiers, Vienne, France, 86000
    - Recruiting
    - CHU Poitiers - La miletrie /ID# 226578
Greece
- - Athens, Greece, 10676
    - Recruiting
    - General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416
  - Ioannina, Greece, 45500
    - Recruiting
    - University General Hospital of Ioannina /ID# 225400
  - Thessaloniki, Greece, 54636
    - Recruiting
    - General University Hospital of Thessaloniki AXEPA /ID# 225398
  - Thessaloniki, Greece, 54639
    - Recruiting
    - Theageneio Anticancer Hospital /ID# 225516
- Attiki
  - Athens, Attiki, Greece, 11528
    - Recruiting
    - Alexandra General Hospital /ID# 225402
  - Athens, Attiki, Greece, 12462
    - Recruiting
    - University General Hospital Attikon /ID# 225401
  - Athens, Attiki, Greece, 11527
    - Recruiting
    - General Hospital of Athens Laiko /ID# 225399
Hungary
- - Budapest, Hungary, 1085
    - Recruiting
    - Semmelweis Egyetem /ID# 227239
  - Budapest, Hungary, 1122
    - Recruiting
    - Orszagos Onkologiai Intezet /ID# 227294
  - Szeged, Hungary, 6720
    - Recruiting
    - Szegedi Tudományegyetem /ID# 226838
  - Szekszard, Hungary, 7100
    - Recruiting
    - Tolna Megyei Balassa Janos Korhaz /ID# 250063
- Gyor-Moson-Sopron
  - Gyor, Gyor-Moson-Sopron, Hungary, 9024
    - Recruiting
    - Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189
- Hajdu-Bihar
  - Debrecen, Hajdu-Bihar, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem-Klinikai Kozpont /ID# 226821
- Somogy
  - Kaposvár, Somogy, Hungary, 7400
    - Recruiting
    - Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938
- Vas
  - Szombathely, Vas, Hungary, 9700
    - Recruiting
    - Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846
Israel
- H_efa
  - Haifa, H_efa, Israel, 4941492
    - Recruiting
    - Rabin Medical Center /ID# 225862
  - Haifa, H_efa, Israel, 3109601
    - Recruiting
    - Rambam Health Care Campus /ID# 225981
- HaMerkaz
  - Kfar Saba, HaMerkaz, Israel, 4428164
    - Recruiting
    - Meir Medical Center /ID# 225612
  - Tel Aviv, HaMerkaz, Israel, 6971028
    - Recruiting
    - Assuta Tel Aviv Medical Center /ID# 226066
- Tel-Aviv
  - Ramat Gan, Tel-Aviv, Israel, 5265601
    - Recruiting
    - The Chaim Sheba Medical Center /ID# 225600
  - Tel Aviv, Tel-Aviv, Israel, 6423906
    - Recruiting
    - Tel Aviv Sourasky Medical Center /ID# 225891
- Yerushalayim
  - Jerusalem, Yerushalayim, Israel, 91120
    - Recruiting
    - Hadassah /ID# 225614
  - Jerusalem, Yerushalayim, Israel, 91031
    - Recruiting
    - Shaare Zedek Medical Center /ID# 259796
Italy
- - Alessandria, Italy, 15100
    - Recruiting
    - Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542
  - Aviano, Italy, 33081
    - Recruiting
    - Centro di Riferimento Oncologico /ID# 225553
  - Brescia, Italy, 25123
    - Recruiting
    - ASST Spedali civili di Brescia /ID# 225549
  - Meldola, Italy, 47014
    - Recruiting
    - Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 252192
  - Napoli, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera Universitaria Federico II /ID# 225543
  - Novara, Italy, 28100
    - Recruiting
    - Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773
  - Palermo, Italy, 90146
    - Recruiting
    - A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541
  - Ravenna, Italy, 48121
    - Recruiting
    - Ospedale Santa Maria delle Croci /ID# 225571
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - Recruiting
    - Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554
- Milano
  - Milan, Milano, Italy, 20141
    - Recruiting
    - IEO -Istituto Europeo di Oncologia /ID# 225545
  - Milan, Milano, Italy, 20132
    - Recruiting
    - Ospedale San Raffaele IRCCS /ID# 225555
- Torino
  - Candiolo, Torino, Italy, 10060
    - Recruiting
    - Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 460-0001
    - Recruiting
    - NHO Nagoya Medical Center /ID# 230677
  - Nagoya-shi, Aichi, Japan, 464-8681
    - Recruiting
    - Aichi Cancer Center Hospital /ID# 226090
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East /ID# 250151
- Ehime
  - Matsuyama-shi, Ehime, Japan, 790-8524
    - Recruiting
    - Matsuyama Red Cross Hospital /ID# 251068
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center /ID# 251622
  - Fukuoka-shi, Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital /ID# 226091
- Fukushima
  - Fukushima-shi, Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital /ID# 250869
- Hokkaido
  - Sapporo-shi, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital /ID# 250149
- Hyogo
  - Kobe-shi, Hyogo, Japan, 650-0047
    - Recruiting
    - Kobe City Medical Center General Hospital /ID# 250597
- Ibaraki
  - Tsukuba-shi, Ibaraki, Japan, 305-8576
    - Recruiting
    - University of Tsukuba Hospital /ID# 251282
- Ishikawa
  - Kanazawa-shi, Ishikawa, Japan, 920-8641
    - Recruiting
    - Kanazawa University Hospital /ID# 251770
- Kagoshima
  - Kagoshima-shi, Kagoshima, Japan, 890-8520
    - Recruiting
    - Kagoshima University Hospital /ID# 250163
- Kanagawa
  - Isehara-shi, Kanagawa, Japan, 259-1193
    - Recruiting
    - Tokai University Hospital /ID# 251281
- Miyagi
  - Sendai-shi, Miyagi, Japan, 9808574
    - Recruiting
    - Tohoku University Hospital /ID# 250150
- Okayama
  - Okayama-shi, Okayama, Japan, 700-8558
    - Recruiting
    - Okayama University Hospital /ID# 250161
- Osaka
  - Osakasayama-shi, Osaka, Japan, 589-8511
    - Recruiting
    - Kindai University Hospital /ID# 250160
  - Suita-shi, Osaka, Japan, 565-0871
    - Recruiting
    - Osaka University Hospital /ID# 251283
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital /ID# 226089
  - Koto-ku, Tokyo, Japan, 135-8550
    - Recruiting
    - The Cancer Institute Hospital Of JFCR /ID# 230269
- Yamagata
  - Yamagata-shi, Yamagata, Japan, 990-9585
    - Recruiting
    - Yamagata University Hospital /ID# 230003
Korea, Republic of
- - Busan, Korea, Republic of, 47392
    - Recruiting
    - Inje University Busan Paik Hospital /ID# 232262
  - Busan, Korea, Republic of, 49201
    - Recruiting
    - Dong-A University Hospital /ID# 228451
  - Daegu, Korea, Republic of, 41931
    - Recruiting
    - Keimyung University Dongsan Medical Center /ID# 232264
  - Jeonju, Korea, Republic of, 54907
    - Recruiting
    - Jeonbuk National University Hospital /ID# 232263
  - Seoul, Korea, Republic of, 06351
    - Recruiting
    - Samsung Medical Center /ID# 225759
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital /ID# 225760
- Gyeonggido
  - Seongnam-si, Gyeonggido, Korea, Republic of, 13620
    - Recruiting
    - Seoul National University Bundang Hospital /ID# 225763
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
    - Recruiting
    - The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
    - Recruiting
    - Asan Medical Center /ID# 225758
- Ulsan Gwang Yeogsi
  - Ulsan, Ulsan Gwang Yeogsi, Korea, Republic of, 44033
    - Recruiting
    - Ulsan University Hospital /ID# 226971
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Recruiting
    - Noordwest Ziekenhuisgroep /ID# 230613
  - Amersfoort, Netherlands, 3813 TZ
    - Recruiting
    - Meander Medisch Centrum /ID# 229608
  - Amsterdam, Netherlands, 1081 HV
    - Recruiting
    - Vrije Universiteit Medisch Centrum /ID# 225608
  - Amsterdam, Netherlands, 1091 AC
    - Recruiting
    - Onze Lieve Vrouwe Gasthuis /ID# 229761
  - Breda, Netherlands, 4818 CK
    - Recruiting
    - Amphia Ziekenhuis /ID# 229550
  - Den Haag, Netherlands, 2512 VA
    - Recruiting
    - Haaglanden Medisch Centrum /ID# 229686
  - Deventer, Netherlands, 7416 SE
    - Recruiting
    - Deventer Ziekenhuis /ID# 229937
  - Eindhoven, Netherlands, 5623 EJ
    - Recruiting
    - Catharina Ziekenhuis /ID# 230465
  - Eindhoven, Netherlands, 5631 BM
    - Recruiting
    - Maxima Medisch Centrum /ID# 225603
  - Enschede, Netherlands, 7512 KZ
    - Recruiting
    - Medisch Spectrum Twente /ID# 225610
  - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Universitair Medisch Centrum Groningen /ID# 225602
  - Haarlem, Netherlands, 2035 RC
    - Recruiting
    - Spaarne Gasthuis /ID# 229621
  - Leeuwarden, Netherlands, 8934 AD
    - Recruiting
    - Medisch Centrum Leeuwarden /ID# 225605
  - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Leids Universitair Medisch Centrum /ID# 225606
  - Maastricht, Netherlands, 6229 HX
    - Recruiting
    - Maastricht Universitair Medisch Centrum /ID# 225607
  - Nieuwegein, Netherlands, 3435 CM
    - Recruiting
    - St. Antonius Ziekenhuis /ID# 229901
  - Nijmegen, Netherlands, 6532 SZ
    - Recruiting
    - Canisius-Wilhelmina Ziekenhuis /ID# 231291
  - S Hertogenbosch, Netherlands, 5223 GZ
    - Recruiting
    - Jeroen Bosch Ziekenhuis /ID# 229765
  - Tilburg, Netherlands, 5022 GC
    - Recruiting
    - Elisabeth Tweesteden Ziekenhuis /ID# 229773
  - Utrecht, Netherlands, 3582 KE
    - Recruiting
    - Diakonessenhuis /ID# 251793
- Flevoland
  - Almere, Flevoland, Netherlands, 1315 RA
    - Recruiting
    - Flevo Ziekenhuis /ID# 229606
- Gelderland
  - Apeldoorn, Gelderland, Netherlands, 7334 DZ
    - Recruiting
    - Gelre Ziekenhuizen /ID# 229762
- Noord-Holland
  - Hilversum, Noord-Holland, Netherlands, 1213 XZ
    - Recruiting
    - Tergooi /ID# 229772
  - Hoorn Nh, Noord-Holland, Netherlands, 1624 NP
    - Recruiting
    - Dijklander Ziekenhuis /ID# 229900
  - Zaandam, Noord-Holland, Netherlands, 1502 DV
    - Recruiting
    - Zaans Medisch Centrum /ID# 230614
- Zuid-Holland
  - Dordrecht, Zuid-Holland, Netherlands, 3318 AT
    - Recruiting
    - Albert Schweitzer Ziekenhuis /ID# 229560
New Zealand
- Auckland
  - Takapuna, Auckland, New Zealand, 0622
    - Recruiting
    - North Shore Hospital /ID# 250992
- Canterbury
  - Christchurch, Canterbury, New Zealand, 8011
    - Recruiting
    - Christchurch Hospital /ID# 250993
Poland
- Pomorskie
  - Slupsk, Pomorskie, Poland, 76-200
    - Recruiting
    - Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723
- Swietokrzyskie
  - Kielce, Swietokrzyskie, Poland, 25-734
    - Recruiting
    - Swietokrzyskie Centrum Onkologii /ID# 225986
- Warminsko-mazurskie
  - Olsztyn, Warminsko-mazurskie, Poland, 10-228
    - Recruiting
    - SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985
- Wielkopolskie
  - Pila, Wielkopolskie, Poland, 64-920
    - Recruiting
    - ARS-MEDICAL Sp. z o.o. /ID# 225848
  - Skorzewo, Wielkopolskie, Poland, 60-185
    - Recruiting
    - Centrum Medyczne Promed - Skorzewo /ID# 227236
Portugal
- - Braga, Portugal, 4710-243
    - Recruiting
    - 2CA-Braga, Hospital de Braga /ID# 249112
  - Lisboa, Portugal, 1649-035
    - Recruiting
    - Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249111
  - Lisboa, Portugal, 1099-023
    - Recruiting
    - IPO Lisboa FG, EPE /ID# 249109
  - Porto, Portugal, 4200-072
    - Recruiting
    - IPO Porto FG, EPE /ID# 249110
Puerto Rico
- - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - Pan American Center for Oncology Trials, LLC /ID# 230052
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2193
    - Recruiting
    - Wits Clinical Research Site /ID# 227803
  - Johannesburg, Gauteng, South Africa, 2193
    - Recruiting
    - Wits Clinical Research Site /ID# 227799
  - Pretoria, Gauteng, South Africa, 0044
    - Recruiting
    - Alberts Cellular Therapy /ID# 227798
- Western Cape
  - Kuilsrivier, Western Cape, South Africa, 7580
    - Recruiting
    - Haemalife Inc. /ID# 243391
Spain
- - Barcelona, Spain, 08041
    - Recruiting
    - Hospital Santa Creu i Sant Pau /ID# 225813
  - Barcelona, Spain, 08003
    - Recruiting
    - Hospital Parc de Salut del Mar /ID# 225810
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitario Vall d'Hebron /ID# 225811
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona /ID# 226651
  - Cordoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofia /ID# 225806
  - Madrid, Spain, 28027
    - Recruiting
    - CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228
  - Madrid, Spain, 28031
    - Recruiting
    - Hospital Universitario Infanta Leonor /ID# 225816
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramon y Cajal /ID# 241750
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre /ID# 225815
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Fundacion Jimenez Diaz /ID# 225804
  - Madrid, Spain, 28033
    - Recruiting
    - MD Anderson Madrid /ID# 225817
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia /ID# 225818
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Recruiting
    - Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063
  - Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Recruiting
    - Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 227393
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Recruiting
    - Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Recruiting
    - Clinica Universidad de Navarra - Pamplona /ID# 225809
Sweden
- - Linkoping, Sweden, 581 85
    - Recruiting
    - Linkoping University Hospital /ID# 233521
  - Solna, Sweden, 171 64
    - Recruiting
    - Karolinska Universitetssjukhuset Solna /ID# 229284
- Skane Lan
  - Lund, Skane Lan, Sweden, 224 84
    - Recruiting
    - Skane University Hospital Lund /ID# 227285
- Vastra Gotalands Lan
  - Boras, Vastra Gotalands Lan, Sweden, 501 82
    - Recruiting
    - Sodra Alvsborgs sjukhus /ID# 228885
  - Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
    - Recruiting
    - Sahlgrenska University Hospital /ID# 250089
Switzerland
- Aargau
  - Aarau, Aargau, Switzerland, 5001
    - Recruiting
    - Kantonsspital Aarau AG /ID# 229112
- Bern
  - Thun, Bern, Switzerland, 3600
    - Recruiting
    - Spital Thun /ID# 229499
- Zuerich
  - Winterthur, Zuerich, Switzerland, 8400
    - Recruiting
    - KSW Kantonsspital Winterthur /ID# 241631
Taiwan
- - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital /ID# 226188
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital /ID# 226674
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital /ID# 226671
- Kaohsiung
  - Kaohsiung City, Kaohsiung, Taiwan, 833
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital /ID# 226670
United Kingdom
- London, City Of
  - London, London, City Of, United Kingdom, W2 1NY
    - Recruiting
    - Imperial College London - St Mary's Hospital /ID# 242215
- Norfolk
  - Norwich, Norfolk, United Kingdom, NR4 7UY
    - Recruiting
    - Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692
United States
- Arizona
  - Tucson, Arizona, United States, 85719-1478
    - Recruiting
    - University of Arizona Cancer Center - North Campus /ID# 227463
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - University of Arkansas for Medical Sciences /ID# 225703
- California
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Orange Coast Memorial Medical Center /ID# 229632
  - Laguna Hills, California, United States, 92653-3689
    - Recruiting
    - Saddleback Memorial Medical Center /ID# 229631
  - Long Beach, California, United States, 90806-1701
    - Recruiting
    - Long Beach Memorial Medical Ct /ID# 228996
  - Los Angeles, California, United States, 90033
    - Recruiting
    - University of Southern California /ID# 225443
  - Los Angeles, California, United States, 90095
    - Recruiting
    - University of California, Los Angeles /ID# 226887
- Florida
  - Orlando, Florida, United States, 32806-2134
    - Recruiting
    - Orlando Health /ID# 232626
- Illinois
  - Springfield, Illinois, United States, 62702
    - Recruiting
    - Southern IL Univ School of Med /ID# 228999
- Indiana
  - Fort Wayne, Indiana, United States, 46845-1739
    - Recruiting
    - Parkview Cancer Institute /ID# 227026
  - Goshen, Indiana, United States, 46526
    - Recruiting
    - Goshen Center for Cancer Care /ID# 225534
- Iowa
  - Des Moines, Iowa, United States, 50314-3017
    - Recruiting
    - Mission Cancer and Blood /ID# 261945
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Norton Cancer Institute - St Matthews /ID# 225420
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - American Oncology Partners of Maryland, PA /ID# 226859
- Michigan
  - Ypsilanti, Michigan, United States, 48197-1051
    - Recruiting
    - Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206
- Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Recruiting
    - Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680
- Montana
  - Billings, Montana, United States, 59102
    - Recruiting
    - Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014
- New Jersey
  - East Brunswick, New Jersey, United States, 08816
    - Recruiting
    - Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654
- New York
  - Mineola, New York, United States, 11501-4064
    - Recruiting
    - Perlmutter Cancer Center at NYU Langone /ID# 262412
  - New York, New York, United States, 10016-4744
    - Recruiting
    - NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141
  - New York, New York, United States, 10065-6007
    - Recruiting
    - Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - Recruiting
    - University of Cincinnati /ID# 225374
- Oregon
  - Portland, Oregon, United States, 97227
    - Recruiting
    - Kaiser Permanente - Northwest /ID# 225488
- Texas
  - Kingwood, Texas, United States, 77339-6008
    - Recruiting
    - Millennium Research & Clinical Development /ID# 228284
- Virginia
  - Charlottesville, Virginia, United States, 22903-3363
    - Recruiting
    - University of Virginia Cancer Center - West Complex /ID# 225433
- Washington
  - Olympia, Washington, United States, 98506-5028
    - Recruiting
    - Vista Oncology - East Olympia /ID# 229375
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Multicare Institute for Research and Innovation /ID# 225432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
- DLBCL, Not Otherwise Specified (NOS).
- High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
- T-cell/histiocyte-rich large B-cell lymphoma.
- Epstein Barr virus-positive DLBCL, NOS.
- Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
Has at least one target lesion defined as:
- >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
- Positron emission tomography (PET)-positive on PET-CT scan.
Laboratory values meeting the criteria laid out in the protocol.
Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

Exclusion Criteria:

History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
Clinically significant cardiovascular disease as per the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epcoritamab and R-CHOP Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.	Drug: Epcoritamab Subcutaneous Injection (SC) Other Names: ABBV-GMAB-3013 Drug: Prednisone Oral; Tablet Drug: Cyclophosphamide Intravenous (IV) Injection Drug: Rituximab IV Infusion Drug: Vincristine IV Infusion Drug: Doxorubicin IV Infusion
Experimental: R-CHOP and Rituximab Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.	Drug: Prednisone Oral; Tablet Drug: Cyclophosphamide Intravenous (IV) Injection Drug: Rituximab IV Infusion Drug: Vincristine IV Infusion Drug: Doxorubicin IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5 Time Frame: Up to Approximately 46 Months	PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.	Up to Approximately 46 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with PFS Time Frame: Up to Approximately 46 Months	PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.	Up to Approximately 46 Months
Number of Participants with Event-free survival (EFS) Time Frame: Up to Approximately 46 Months	EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.	Up to Approximately 46 Months
Percentage of Participants with Complete Remission (CR) Time Frame: On or After to Approximately 28 Weeks	CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.	On or After to Approximately 28 Weeks
Overall survival (OS) Time Frame: Up to Approximately 76 Months	OS is defined as time from randomization until death due to any causes.	Up to Approximately 76 Months
Percentage of Participants with Minimal Residual Disease (MRD) Negativity Time Frame: Up to Approximately 46 Months	The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.	Up to Approximately 46 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Genmab

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M20-621
2021-000168-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Terminated

First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

Follicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Chronic Lymphocytic Leukemia | Diffuse Large B-cell Lymphoma | Small Lymphocytic Lymphoma | High-grade B-cell Lymphoma | Primary Mediastinal Large B-cell Lymphoma

United States, Spain, Netherlands, Belgium, France, Denmark
Australasian Leukaemia and Lymphoma Group

Not yet recruiting

Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL

High-grade B-cell Lymphoma | DLBCL - Diffuse Large B Cell Lymphoma | High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | DLBCL, Nos Genetic Subtypes | High Grade B-Cell Lymphoma, Not Otherwise Specified | Follicular Large Cell Lymphoma, Relapsed | Follicular Large Cell Lymphoma
Reid Merryman, MD
AbbVie; Genmab

Recruiting

Epcoritamab and Rituximab for First-line Follicular Lymphoma

Follicular Lymphoma | Low Grade Non-Hodgkin's Lymphoma, Adult

United States

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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