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)

Diffuse Large B-Cell Lymphoma Clinical Trial

— EPCORE DLBCL-2  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578976
• Other study ID #: M20-621
• Secondary ID: 2021-000168-31
• Status: Recruiting
• Phase: Phase 3
• Start date: February 8, 2023
• Est. completion date: December 30, 2029

Study information

• Verified date: May 2024
• Source: Genmab
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 30, 2029
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Epcoritamab
Subcutaneous Injection (SC)
• Cyclophosphamide
Intravenous (IV) Injection
• Rituximab
IV Infusion
• Vincristine
IV Infusion
• Doxorubicin
IV Infusion
• Prednisone
Oral; Tablet

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 225683	Adelaide	South Australia
Australia	Monash Medical Centre /ID# 225680	Clayton	Victoria
Australia	Austin Health /ID# 225716	Heidelberg	Victoria
Australia	Liverpool Hospital /ID# 230072	Liverpool	New South Wales
Australia	Alfred Health /ID# 225999	Melbourne	Victoria
Australia	Hollywood Private Hospital /ID# 251837	Nedlands	Western Australia
Australia	Perth Blood Institute Ltd /ID# 225679	Nedlands	Western Australia
Australia	Royal Perth Hospital /ID# 226583	Perth	Western Australia
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228360	Salzburg
Austria	Universitaetsklinikum St. Poelten /ID# 234016	Sankt Poelten	Niederoesterreich
Austria	Klinik Ottakring /ID# 243941	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 252095	Vienna	Wien
Belgium	Institut Jules Bordet /ID# 225954	Anderlecht
Belgium	ZNA Cadix /ID# 264327	Antwerp
Belgium	ZNA Middelheim /ID# 225741	Antwerp
Belgium	AZ Sint-Jan Brugge /ID# 225735	Brugge
Belgium	UZ Gent /ID# 250031	Gent	Oost-Vlaanderen
Belgium	Hospital La Louviere Site Jolimont - Helora /ID# 225738	La Louvière	Hainaut
Belgium	Universitair Ziekenhuis Leuven /ID# 225951	Leuven	Vlaams-Brabant
Belgium	CHU de Liège /ID# 225952	Liège	Liege
Belgium	AZ-Delta /ID# 225736	Roeselare	West-Vlaanderen
Belgium	Vitaz /Id# 226153	Sint-Niklaas	Oost-Vlaanderen
Belgium	Cliniques Universitaires UCL Saint-Luc /ID# 225737	Woluwe-Saint-Lambert	Bruxelles-Capitale
Belgium	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 225742	Yvoir	Namur
Brazil	Hospital de Clinicas da Universidade Federal do Parana /ID# 226027	Curitiba	Parana
Brazil	Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065	Jaú	Sao Paulo
Brazil	Hospital Alemao Oswaldo Cruz /ID# 252833	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226048	Sao Paulo
Brazil	Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023	Sao Paulo
Brazil	Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809	São Paulo	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 252832	São Paulo	Sao Paulo
Bulgaria	UMHAT Sveti Georgi /ID# 245780	Plovdiv
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616	Sofia
Bulgaria	SHAT Hematologic Diseases /ID# 250102	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 244615	Sofia
Canada	William Osler Health System /ID# 250973	Brampton	Ontario
Canada	Tom Baker Cancer Centre /ID# 226077	Calgary	Alberta
Canada	Juravinski Cancer Centre /ID# 226084	Hamilton	Ontario
Canada	Saskatoon Cancer Centre /ID# 226082	Saskatoon	Saskatchewan
Canada	BC Cancer - Vancouver /ID# 230573	Vancouver	British Columbia
China	Beijing Cancer Hospital /ID# 229819	Beijing	Beijing
China	Peking University Third Hospital /ID# 230975	Beijing	Beijing
China	The Fifth Medical Center of PLA General Hospital /ID# 230941	Beijing	Beijing
China	The First Hospital of Jilin University /ID# 239618	Changchun	Jilin
China	Fujian Provincial Cancer Hospital /ID# 238430	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital /ID# 230945	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University /ID# 238436	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center /ID# 238371	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 231249	Hangzhou	Zhejiang
China	Zhejiang Cancer hospital /ID# 231388	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital /Id# 241755	Harbin	Heilongjiang
China	Shandong Cancer Hospital /ID# 233200	Jinan	Shandong
China	Jiangxi Provincial Cancer Hospital /ID# 233379	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University /ID# 230399	Nanchang	Jiangxi
China	Fudan University Cancer Hospital /ID# 251516	Shanghai	Shanghai
China	The First Hospital of China Medical University /ID# 233201	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University /ID# 232569	Suzhou	Jiangsu
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259904	Tianjin	Tianjin
China	Tianjin Cancer Hospital /ID# 230974	Tianjin	Tianjin
China	Hubei Cancer Hospital /ID# 232256	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University /ID# 238426	Xiamen	Fujian
China	The Affiliated Hospital of Xuzhou Medical College /ID# 233174	Xuzhou	Jiangsu
China	Henan Cancer Hospital /ID# 230398	Zhengzhou	Henan
Croatia	Klinicki bolnicki centar Rijeka /ID# 251811	Rijeka	Primorsko-goranska Zupanija
Croatia	Opca bolnica Dr. Josip Bencevic /ID# 251812	Slavonski Brod
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 250729	Split	Splitsko-dalmatinska Zupanija
Croatia	Clinical Hospital Dubrava /ID# 251809	Zagreb	Grad Zagreb
Croatia	Klinicka bolnica Merkur /ID# 252481	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 250709	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice Brno /ID# 225953	Brno
Czechia	Fakultni nemocnice Hradec Kralove /ID# 225955	Hradec Kralove
Czechia	Fakultni Nemocnice Ostrava /ID# 225957	Ostrava
Czechia	Duplicate_Fakultni Nemocnice v Motole /ID# 225958	Prague
Czechia	Fakultni nemocnice Kralovske Vinohrady /ID# 225956	Praha
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 225396	Praha
Denmark	Aarhus Universitetshospital - Skejby /ID# 226594	Aarhus	Midtjylland
Denmark	Rigshospitalet /ID# 226576	Copenhagen Ø	Hovedstaden
Denmark	Odense University Hospital /ID# 226593	Odense C	Syddanmark
Denmark	Roskilde Sygehus /ID# 226597	Roskilde	Sjælland
Denmark	Sygehus Lillebalt, Vejle /ID# 226592	Vejle	Syddanmark
France	CHU Amiens-Picardie Site Sud /ID# 238347	Amiens CEDEX 1	Somme
France	Chu Angers /Id# 245931	Angers
France	Centre Hospitalier de la Cote Basque /ID# 249143	Bayonne	Pyrenees-Atlantiques
France	CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582	Caen
France	Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 226560	Créteil
France	CHU Dijon /ID# 238345	Dijon	Cote-d Or
France	CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899	La Roche Sur Yon	Vendee
France	CHU Grenoble - Hopital Michallon /ID# 226128	La Tronche
France	CHRU Lille - Hopital Claude Huriez /ID# 226101	Lille	Nord
France	CHU Limoges - Dupuytren 1 /ID# 234235	Limoges CEDEX 1	Franche-Comte
France	Institut Paoli-Calmettes /ID# 226557	Marseille	Bouches-du-Rhone
France	CHU Montpellier - Hôpital Saint Eloi /ID# 228191	Montpellier Cedex 5	Herault
France	CHU de Nantes, Hotel Dieu -HME /ID# 226125	Nantes	Pays-de-la-Loire
France	CHU de Nice - Hôpital Archet 1 /ID# 226127	Nice	Alpes-Maritimes
France	AP-HP - Hopital Saint-Louis /ID# 226126	Paris
France	HCL - Hopital Lyon Sud /ID# 227086	Pierre Benite CEDEX	Rhone
France	CHU Poitiers - La miletrie /ID# 226578	Poitiers	Vienne
France	CHU de Rennes - PONTCHAILLOU /ID# 228207	Rennes	Bretagne
France	Centre Henri Becquerel /ID# 226103	Rouen
France	Institut Curie - site CLCC René Huguenin /ID# 253519	Saint-cloud
France	CHRU Nancy - Hopitaux de Brabois /ID# 226102	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Greece	Alexandra General Hospital /ID# 225402	Athens	Attiki
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416	Athens
Greece	General Hospital of Athens Laiko /ID# 225399	Athens	Attiki
Greece	University General Hospital Attikon /ID# 225401	Athens	Attiki
Greece	University General Hospital of Ioannina /ID# 225400	Ioannina
Greece	General University Hospital of Thessaloniki AXEPA /ID# 225398	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 225516	Thessaloniki
Hungary	Orszagos Onkologiai Intezet /ID# 227294	Budapest
Hungary	Semmelweis Egyetem /ID# 227239	Budapest
Hungary	Debreceni Egyetem-Klinikai Kozpont /ID# 226821	Debrecen	Hajdu-Bihar
Hungary	Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 257189	Gyor	Gyor-Moson-Sopron
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245938	Kaposvár	Somogy
Hungary	Szegedi Tudományegyetem /ID# 226838	Szeged
Hungary	Tolna Varmegyei Balassa Janos Korhaz /ID# 250063	Szekszard	Tolna
Hungary	Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 226846	Szombathely	Vas
Israel	Rabin Medical Center /ID# 225862	Haifa
Israel	Rambam Health Care Campus /ID# 225981	Haifa	H_efa
Israel	Hadassah /ID# 225614	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 259796	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 225612	Kfar Saba	HaMerkaz
Israel	The Chaim Sheba Medical Center /ID# 225600	Ramat Gan	Tel-Aviv
Israel	Assuta Tel Aviv Medical Center /ID# 226066	Tel Aviv	HaMerkaz
Israel	Tel Aviv Sourasky Medical Center /ID# 225891	Tel Aviv	Tel-Aviv
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542	Alessandria
Italy	Centro di Riferimento Oncologico /ID# 225553	Aviano
Italy	ASST Spedali civili di Brescia /ID# 225549	Brescia
Italy	Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 225751	Candiolo	Torino
Italy	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 252192	Meldola
Italy	IEO -Istituto Europeo di Oncologia /ID# 225545	Milan	Milano
Italy	Ospedale San Raffaele IRCCS /ID# 225555	Milan	Milano
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 225543	Napoli
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773	Novara
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541	Palermo
Italy	Azienda Ospedaliero Universitaria Pisana /ID# 225575	Pisa
Italy	Ospedale Santa Maria delle Croci /ID# 225571	Ravenna
Italy	Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554	San Giovanni Rotondo	Foggia
Japan	National Cancer Center Hospital /ID# 226089	Chuo-ku	Tokyo
Japan	Kyushu University Hospital /ID# 226091	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center /ID# 251622	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 250869	Fukushima-shi	Fukushima
Japan	Tokai University Hospital- Isehara Campus /ID# 251281	Isehara	Kanagawa
Japan	Kagoshima University Hospital /ID# 250163	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 251770	Kanazawa-shi	Ishikawa
Japan	National Cancer Center Hospital East /ID# 250151	Kashiwa-shi	Chiba
Japan	Kobe City Medical Center General Hospital /ID# 250597	Kobe-shi	Hyogo
Japan	The Cancer Institute Hospital Of JFCR /ID# 230269	Koto	Tokyo
Japan	Matsuyama Red Cross Hospital /ID# 251068	Matsuyama-shi	Ehime
Japan	Aichi Cancer Center Hospital /ID# 226090	Nagoya-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 230677	Nagoya-shi	Aichi
Japan	Okayama University Hospital /ID# 250161	Okayama
Japan	Kindai University Hospital /ID# 250160	Osakasayama-shi	Osaka
Japan	Hokkaido University Hospital /ID# 250149	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 250150	Sendai-shi	Miyagi
Japan	Osaka University Hospital /ID# 251283	Suita-shi	Osaka
Japan	University of Tsukuba Hospital /ID# 251282	Tsukuba-shi	Ibaraki
Japan	Yamagata University Hospital /ID# 230003	Yamagata-shi	Yamagata
Korea, Republic of	Dong-A University Medical Center /ID# 228451	Busan	Gyeongsangnamdo
Korea, Republic of	Inje University - Busan Paik Hospital /ID# 232262	Busan	Busan Gwang Yeogsi
Korea, Republic of	Keimyung University Dongsan Hospital /ID# 232264	Daegu	Gyeongsangbugdo
Korea, Republic of	Jeonbuk National University Hospital /ID# 232263	Jeonju	Jeonrabugdo
Korea, Republic of	Seoul National University Bundang Hospital /ID# 225763	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 225758	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 225759	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 225760	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital /ID# 225761	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Ulsan University Hospital /ID# 226971	Ulsan	Ulsan Gwang Yeogsi
Netherlands	Noordwest Ziekenhuisgroep /ID# 230613	Alkmaar
Netherlands	Flevo Ziekenhuis /ID# 229606	Almere	Flevoland
Netherlands	Meander Medisch Centrum /ID# 229608	Amersfoort
Netherlands	Onze Lieve Vrouwe Gasthuis /ID# 229761	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum /ID# 225608	Amsterdam
Netherlands	Gelre Ziekenhuizen /ID# 229762	Apeldoorn	Gelderland
Netherlands	Amphia Ziekenhuis /ID# 229550	Breda	Noord-Brabant
Netherlands	Haaglanden Medisch Centrum /ID# 229686	Den Haag
Netherlands	Deventer Ziekenhuis /ID# 229937	Deventer
Netherlands	Albert Schweitzer Ziekenhuis /ID# 229560	Dordrecht	Zuid-Holland
Netherlands	Catharina Ziekenhuis /ID# 230465	Eindhoven
Netherlands	Maxima Medisch Centrum /ID# 225603	Eindhoven
Netherlands	Medisch Spectrum Twente /ID# 225610	Enschede
Netherlands	Universitair Medisch Centrum Groningen /ID# 225602	Groningen
Netherlands	Spaarne Gasthuis, Haarlem Zuid /ID# 229621	Haarlem	Noord-Holland
Netherlands	Tergooi /ID# 229772	Hilversum	Noord-Holland
Netherlands	Dijklander Ziekenhuis /ID# 229900	Hoorn Nh	Noord-Holland
Netherlands	Medisch Centrum Leeuwarden /ID# 225605	Leeuwarden
Netherlands	Leids Universitair Medisch Centrum /ID# 225606	Leiden
Netherlands	Maastricht Universitair Medisch Centrum /ID# 225607	Maastricht
Netherlands	St. Antonius Ziekenhuis /ID# 229901	Nieuwegein
Netherlands	Canisius-Wilhelmina Ziekenhuis /ID# 231291	Nijmegen
Netherlands	Jeroen Bosch Ziekenhuis /ID# 229765	S Hertogenbosch
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 229773	Tilburg
Netherlands	Diakonessenhuis /ID# 251793	Utrecht
Netherlands	Zaans Medisch Centrum /ID# 230614	Zaandam	Noord-Holland
New Zealand	Christchurch Hospital /ID# 250993	Christchurch	Canterbury
New Zealand	North Shore Hospital /ID# 250992	Takapuna	Auckland
Poland	Swietokrzyskie Centrum Onkologii /ID# 225986	Kielce	Swietokrzyskie
Poland	SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985	Olsztyn	Warminsko-mazurskie
Poland	ARS-MEDICAL Sp. z o.o. /ID# 225848	Pila	Wielkopolskie
Poland	Centrum Medyczne Promed - Skorzewo /ID# 227236	Skorzewo	Wielkopolskie
Poland	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723	Slupsk	Pomorskie
Portugal	2CA-Braga, Hospital de Braga /ID# 249112	Braga
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249111	Lisboa
Portugal	IPO Lisboa FG, EPE /ID# 249109	Lisboa
Portugal	IPO Porto FG, EPE /ID# 249110	Porto
Puerto Rico	Hematology and Oncology Institute /ID# 230054	Manati
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 230052	Rio Piedras
Slovakia	Narodny onkologicky ustav /ID# 238847	Bratislava	Nitriansky Kraj
South Africa	Wits Clinical Research /ID# 227799	Johannesburg	Gauteng
South Africa	Wits Clinical Research /ID# 227803	Johannesburg	Gauteng
South Africa	Haemalife Inc. /ID# 243391	Kuilsrivier	Western Cape
South Africa	Alberts Cellular Therapy /ID# 227798	Pretoria	Gauteng
Spain	Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona /ID# 226651	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 225810	Barcelona
Spain	Hospital Santa Creu i Sant Pau /ID# 225813	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 225811	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 225806	Córdoba	Cordoba
Spain	Hospital Clinico Universitario Virgen de la Arrixaca /ID# 255381	El Palmar	Murcia
Spain	Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 227393	Hospitalet de Llobregat	Barcelona
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 225815	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 225804	Madrid
Spain	Hospital Universitario Infanta Leonor /ID# 225816	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 241750	Madrid
Spain	MD Anderson Madrid /ID# 225817	Madrid
Spain	Clinica Universidad de Navarra - Pamplona /ID# 225809	Pamplona	Navarra
Spain	Hospital Clinico Universitario de Valencia /ID# 225818	Valencia
Sweden	Sodra Alvsborgs sjukhus /ID# 228885	Boras	Vastra Gotalands Lan
Sweden	Sahlgrenska Universitetssjukhuset /ID# 250089	Göteborg	Vastra Gotalands Lan
Sweden	Linkoping University Hospital /ID# 233521	Linkoping
Sweden	Skane University Hospital Lund /ID# 227285	Lund	Skane Lan
Sweden	Karolinska Universitetssjukhuset Solna /ID# 229284	Solna
Switzerland	Kantonsspital Aarau AG /ID# 229112	Aarau	Aargau
Switzerland	Spital Thun /ID# 229499	Thun	Bern
Switzerland	KSW Kantonsspital Winterthur /ID# 241631	Winterthur	Zuerich
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 226670	Kaohsiung City	Kaohsiung
Taiwan	China Medical University Hospital /ID# 226188	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 226674	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 226671	Tainan
Turkey	Ankara Universitesi Fakultesi /ID# 227331	Ankara
Turkey	Anadolu Saglik Merkezi /ID# 225777	Dilovasi	Kocaeli
Turkey	Inonu University Medical Faculty /ID# 226572	Malatya
Turkey	Ondokuz Mayis Universitesi Tip /ID# 251247	Samsun
Turkey	Karadeniz University /ID# 226573	Trabzon
Turkey	Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921	Yuregir
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 229197	Birmingham
United Kingdom	Imperial College London - St Mary's Hospital /ID# 242215	London	London, City Of
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692	Norwich	Norfolk
United States	Presbyterian Kaseman Hospital /ID# 262084	Albuquerque	New Mexico
United States	University of New Mexico /ID# 227332	Albuquerque	New Mexico
United States	American Oncology Partners of Maryland, PA /ID# 226859	Bethesda	Maryland
United States	Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 259014	Billings	Montana
United States	Novant Health Presbyterian Medical Center /ID# 227753	Charlotte	North Carolina
United States	University of Virginia Cancer Center - West Complex /ID# 225433	Charlottesville	Virginia
United States	University of Cincinnati /ID# 225374	Cincinnati	Ohio
United States	Mission Cancer and Blood /ID# 261945	Des Moines	Iowa
United States	Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654	East Brunswick	New Jersey
United States	Parkview Cancer Institute /ID# 227026	Fort Wayne	Indiana
United States	Orange Coast Memorial Medical Center /ID# 229632	Fountain Valley	California
United States	Goshen Center for Cancer Care /ID# 225534	Goshen	Indiana
United States	Cancer Specialists of North Florida /ID# 226826	Jacksonville	Florida
United States	Millennium Research & Clinical Development /ID# 228284	Kingwood	Texas
United States	Saddleback Memorial Medical Center /ID# 229631	Laguna Hills	California
United States	NHO Revive Research Institute, LLC /ID# 261113	Lincoln	Nebraska
United States	University of Arkansas for Medical Sciences /ID# 225703	Little Rock	Arkansas
United States	Long Beach Memorial Medical Ct /ID# 228996	Long Beach	California
United States	University of California, Los Angeles /ID# 226887	Los Angeles	California
United States	University of Southern California /ID# 225443	Los Angeles	California
United States	Norton Cancer Institute - St Matthews /ID# 225420	Louisville	Kentucky
United States	NYU Langone Hospital - Long Island /ID# 262412	Mineola	New York
United States	Intermountain Medical Center /ID# 231184	Murray	Utah
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379	New York	New York
United States	NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141	New York	New York
United States	Vista Oncology - East Olympia /ID# 229375	Olympia	Washington
United States	UF Health Cancer Center at Orlando Health /ID# 232626	Orlando	Florida
United States	Kaiser Permanente - Northwest /ID# 225488	Portland	Oregon
United States	Presbyterian Rust Medical Center /ID# 262068	Rio Rancho	New Mexico
United States	Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 226680	Saint Louis Park	Minnesota
United States	Southern IL Univ School of Med /ID# 228999	Springfield	Illinois
United States	Multicare Institute for Research and Innovation /ID# 225432	Tacoma	Washington
United States	University of Arizona Cancer Center - North Campus /ID# 227463	Tucson	Arizona
United States	Novant Health Forsyth Medical Center /ID# 228339	Winston-Salem	North Carolina
United States	Trinity Health St. Joseph Mercy Ann Arbor /ID# 228206	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Genmab	AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Denmark,  France,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5	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	Number of Participants with PFS	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
Secondary	Number of Participants with Event-free survival (EFS)	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
Secondary	Percentage of Participants with Complete Remission (CR)	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
Secondary	Overall survival (OS)	OS is defined as time from randomization until death due to any causes.	Up to Approximately 76 Months
Secondary	Percentage of Participants with Minimal Residual Disease (MRD) Negativity	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

External Links

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