Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

Follicular Lymphoma (FL) Clinical Trial

— EPCORE FL-1  

Official title:

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409066
• Other study ID #: M20-638
• Secondary ID: 2021-000169-34
• Status: Recruiting
• Phase: Phase 3
• Start date: September 20, 2022
• Est. completion date: June 16, 2030

Study information

• Verified date: June 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

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 16, 2030
• Est. primary completion date: November 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.

• Participant has:

• Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND

• >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.

• Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.

• Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)

• Eligible to receive R2 per investigator determination.

• Estimated Creatinine Clearance (CrCl) >= 50 mL/min.

Exclusion Criteria:

• Documented refractoriness to lenalidomide.

• Have lenalidomide exposure within 12 months prior to randomization.

Related Conditions & MeSH terms

• Follicular Lymphoma (FL)
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Epcoritamab
Subcutaneous Injection
• Rituximab
Intravenous Infusion
• Lenalidomide
Oral Capsules

Locations

Country	Name	City	State
Argentina	Cemic /Id# 229697	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Fundaleu /Id# 229700	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701	Cordoba
Argentina	Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124	Santa Fe
Australia	Royal Prince Alfred Hospital /ID# 239272	Camperdown	New South Wales
Australia	Townsville University Hospital /ID# 231124	Douglas	Queensland
Australia	Peninsula Private Hospital /ID# 238796	Frankston	Victoria
Australia	Nepean Hospital /ID# 239093	Kingswood	New South Wales
Australia	Fiona Stanley Hospital /ID# 231122	Murdoch	Western Australia
Australia	Hollywood Medical Centre /ID# 251789	Nedlands	Western Australia
Australia	Royal Perth Hospital /ID# 230456	Perth	Western Australia
Austria	Ordensklinikum Linz GmbH Elisabethinen /ID# 247510	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366	Salzburg
Austria	Universitaetsklinikum St. Poelten /ID# 234015	Sankt Poelten	Niederoesterreich
Belgium	Institut Jules Bordet /ID# 254676	Anderlecht
Belgium	Uza /Id# 228521	Edegem	Antwerpen
Belgium	Hospital La Louviere Site Jolimont - Helora /ID# 228520	La Louvière	Hainaut
Belgium	Universitair Ziekenhuis Leuven /ID# 247780	Leuven	Vlaams-Brabant
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 230415	Liege
Belgium	Vitaz /Id# 228525	Sint-Niklaas	Oost-Vlaanderen
Belgium	AZ Turnhout - Campus Sint-Elisabeth /ID# 231628	Turnhout
Brazil	Upeclin Fmb - Unesp /Id# 252912	Botucatu	Sao Paulo
Brazil	Hospital de Clinicas da Universidade Federal do Parana /ID# 228123	Curitiba	Parana
Brazil	Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129	Jaú	Sao Paulo
Brazil	Instituto Nacional de Cancer (INCA) /ID# 228706	Rio de Janeiro
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127	Sao Paulo
Brazil	Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918	Sao Paulo
Brazil	Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182	Sao Paulo
Brazil	Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121	Sao Paulo
Brazil	Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130	São Paulo	Sao Paulo
Canada	Cross Cancer Institute /ID# 249080	Edmonton	Alberta
Canada	CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896	Levis	Quebec
Canada	CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537	Quebec City	Quebec
Canada	CISSSBSL -Hopital regional de Rimouski /ID# 229894	Rimouski	Quebec
Canada	BC Cancer - Victoria /ID# 228850	Victoria	British Columbia
China	Peking University First Hospital /ID# 250517	Beijing	Beijing
China	Peking University Third Hospital /ID# 230885	Beijing	Beijing
China	Fujian Medical University Union Hospital /ID# 233919	Fuzhou	Fujian
China	Guangdong Provincial Peoples Hospital(Huifu Campus) /ID# 232512	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University /ID# 230383	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center /ID# 231463	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 231250	Hangzhou	Zhejiang
China	Zhejiang Cancer hospital /ID# 231389	Hangzhou	Zhejiang
China	Jiangxi Provincial Cancer Hospital /ID# 232507	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University /ID# 231047	Nanchang	Jiangxi
China	Fudan University Cancer Hospital /ID# 250475	Shanghai	Shanghai
China	The First Hospital of China Medical University /ID# 232509	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University /ID# 232511	Suzhou	Jiangsu
China	Tianjin Cancer Hospital /ID# 230876	Tianjin	Tianjin
China	Hubei Cancer Hospital /ID# 232255	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153	Wuhan	Hubei
China	Xijing Hospital /ID# 238650	Xi'an	Shaanxi
China	The Affiliated Hospital of Xuzhou Medical College /ID# 232513	Xuzhou	Jiangsu
China	Henan Cancer Hospital /ID# 230459	Zhengzhou	Henan
Czechia	Fakultni nemocnice Hradec Kralove /ID# 228269	Hradec Kralove
Czechia	Duplicate_Fakultni Nemocnice v Motole /ID# 228272	Prague
Czechia	Fakultni nemocnice Kralovske Vinohrady /ID# 228564	Praha
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 228565	Praha
Denmark	Regionshospitalet Godstrup /ID# 227466	Herning	Midtjylland
Denmark	Sygehus Lillebalt, Vejle /ID# 227404	Vejle	Syddanmark
France	CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929	Caen
France	CHU Clermont-Ferrand /ID# 238676	Clermont	Auvergne-Rhone-Alpes
France	Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 230358	Creteil	Paris
France	CHU Dijon /ID# 230354	Dijon	Cote-d Or
France	CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095	La Roche Sur Yon	Vendee
France	CHRU Lille - Hopital Claude Huriez /ID# 230353	Lille	Nord
France	CHU Limoges - Dupuytren 1 /ID# 231450	Limoges CEDEX 1	Franche-Comte
France	Centre Leon Berard /ID# 230348	Lyon CEDEX 08	Rhone
France	CHU de Nantes, Hotel Dieu -HME /ID# 245928	Nantes	Pays-de-la-Loire
France	CHU NIMES - Hopital Caremeau /ID# 230351	Nimes CEDEX 9	Gard
France	AP-HP - Hopital Saint-Louis /ID# 232067	Paris
France	Hopital Pitie Salpetriere /ID# 230360	Paris
France	Centre Hospitalier Universitaire de Bordeaux /ID# 230347	Pessac CEDEX	Gironde
France	HCL - Hopital Lyon Sud /ID# 231449	Pierre Benite CEDEX	Rhone
France	CHU Poitiers - La miletrie /ID# 230357	Poitiers	Vienne
France	CHU Reims - Hôpital Robert Debre /ID# 248710	Reims CEDEX	Marne
France	CHU de Rennes - PONTCHAILLOU /ID# 230356	Rennes	Bretagne
France	IUCT Oncopole /ID# 233486	Toulouse Cedex 9
France	CHRU Nancy - Hopitaux de Brabois /ID# 241595	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	Sozialstiftung Bamberg /ID# 229184	Bamberg
Germany	Helios Klinikum Berlin-Buch /ID# 229178	Berlin
Germany	Universitaetsklinikum Bonn /ID# 249401	Bonn
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 229754	Dresden
Germany	Universitaetsklinikum Essen /ID# 229180	Essen
Germany	Universitaetsklinikum Giessen /ID# 234245	Gießen	Hessen
Germany	Universitaetsmedizin Goettingen /ID# 230411	Goettingen
Germany	Universitaetsklinikum Jena /ID# 232064	Jena	Thueringen
Germany	Klinikum Kassel /ID# 229185	Kassel	Hessen
Germany	Universitaetsklinikum Leipzig /ID# 242907	Leipzig	Sachsen
Germany	Otto-von-Guericke-Universitaet /ID# 230144	Magdeburg
Germany	Klinikum Mutterhaus der Borromäerinnen /ID# 232354	Trier
Germany	Universitaetsklinikum Tuebingen /ID# 229663	Tubingen	Baden-Wuerttemberg
Germany	Universitaetsklinikum Wuerzburg /ID# 229278	Wuerzburg
Greece	Alexandra General Hospital /ID# 226632	Athens	Attiki
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633	Athens
Greece	General Hospital of Athens Laiko /ID# 226626	Athens	Attiki
Greece	University General Hospital Attikon /ID# 226629	Athens	Attiki
Greece	University General Hospital of Ioannina /ID# 226628	Ioannina
Greece	General University Hospital of Thessaloniki AXEPA /ID# 226630	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 226627	Thessaloniki
Hungary	Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286	Budapest
Hungary	Orszagos Onkologiai Intezet /ID# 229292	Budapest
Hungary	Semmelweis Egyetem /ID# 229291	Budapest
Hungary	Debreceni Egyetem-Klinikai Kozpont /ID# 229287	Debrecen	Hajdu-Bihar
Hungary	Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475	Kaposvár	Somogy
Hungary	Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203	Nyiregyhaza	Szabolcs-Szatmar-Bereg
Hungary	Szegedi Tudományegyetem /ID# 229289	Szeged
Hungary	Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290	Szombathely	Vas
Israel	Rabin Medical Center /ID# 228043	Haifa
Israel	Rambam Health Care Campus /ID# 227849	Haifa	H_efa
Israel	Hadassah /ID# 227846	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 228322	Ramat Gan	Tel-Aviv
Israel	ZIV Medical Center /ID# 232257	Safed	HaTsafon
Israel	Tel Aviv Sourasky Medical Center /ID# 228529	Tel Aviv	Tel-Aviv
Israel	Yitzhak Shamir Medical Center /ID# 228037	Zerifin	HaMerkaz
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401	Alessandria
Italy	Centro di Riferimento Oncologico /ID# 227395	Aviano
Italy	I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400	Bari
Italy	ASST Spedali civili di Brescia /ID# 227397	Brescia
Italy	Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602	Candiolo	Torino
Italy	IEO -Istituto Europeo di Oncologia /ID# 227396	Milan	Milano
Italy	Ospedale San Raffaele IRCCS /ID# 228669	Milan	Milano
Italy	Azienda Ospedaliera Universitaria Federico II /ID# 230403	Napoli
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399	Novara
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402	Palermo
Italy	Ospedale Santa Maria delle Croci /ID# 227394	Ravenna
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 230402	Rome	Lazio
Italy	Ospedale Casa Sollievo Della Sofferenza /ID# 228458	San Giovanni Rotondo	Foggia
Italy	AOU Citta della Salute e della Scienza di Torino /ID# 229820	Torino	Piemonte
Japan	National Cancer Center Hospital /ID# 230004	Chuo-ku	Tokyo
Japan	Kyushu University Hospital /ID# 230136	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center /ID# 252245	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital /ID# 251839	Fukushima-shi	Fukushima
Japan	Tokai University Hospital- Isehara Campus /ID# 252135	Isehara	Kanagawa
Japan	Kagoshima University Hospital /ID# 232251	Kagoshima-shi	Kagoshima
Japan	National Cancer Center Hospital East /ID# 232423	Kashiwa-shi	Chiba
Japan	Kobe City Medical Center General Hospital /ID# 251945	Kobe-shi	Hyogo
Japan	Yamanashi Prefectural Central Hospital /ID# 263715	Kofu	Yamanashi
Japan	The Cancer Institute Hospital Of JFCR /ID# 230271	Koto	Tokyo
Japan	Kyoto University Hospital /ID# 231156	Kyoto-shi	Kyoto
Japan	Shinshu University Hospital /ID# 252246	Matsumoto-shi	Nagano
Japan	Matsuyama Red Cross Hospital /ID# 251866	Matsuyama-shi	Ehime
Japan	Aichi Cancer Center Hospital /ID# 230134	Nagoya-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 230678	Nagoya-shi	Aichi
Japan	Okayama University Hospital /ID# 232009	Okayama
Japan	Kindai University Hospital /ID# 232152	Osakasayama-shi	Osaka
Japan	Hokkaido University Hospital /ID# 231443	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 232303	Sendai-shi	Miyagi
Japan	Mie University Hospital /ID# 251944	Tsu-shi	Mie
Japan	Yamagata University Hospital /ID# 230005	Yamagata-shi	Yamagata
Korea, Republic of	Dong-A University Medical Center /ID# 228638	Busan	Gyeongsangnamdo
Korea, Republic of	Inje University - Busan Paik Hospital /ID# 230293	Busan	Busan Gwang Yeogsi
Korea, Republic of	Pusan National University Hospital /ID# 229798	Busan
Korea, Republic of	Keimyung University Dongsan Hospital /ID# 229800	Daegu	Gyeongsangbugdo
Korea, Republic of	Jeonbuk National University Hospital /ID# 228908	Jeonju	Jeonrabugdo
Korea, Republic of	Seoul National University Bundang Hospital /ID# 228448	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 228444	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 228445	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 228446	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447	Seoul	Seoul Teugbyeolsi
Netherlands	Onze Lieve Vrouwe Gasthuis /ID# 247899	Amsterdam
Netherlands	Amphia Ziekenhuis /ID# 247739	Breda	Noord-Brabant
Netherlands	Deventer Ziekenhuis /ID# 247853	Deventer
Netherlands	Albert Schweitzer Ziekenhuis /ID# 247740	Dordrecht	Zuid-Holland
Netherlands	Medisch Spectrum Twente /ID# 247854	Enschede
Netherlands	Admiraal de Ruyter Ziekenhuis /ID# 247692	Goes
Netherlands	Universitair Medisch Centrum Groningen /ID# 247741	Groningen
Netherlands	Dijklander Ziekenhuis /ID# 248993	Hoorn Nh	Noord-Holland
Netherlands	Leids Universitair Medisch Centrum /ID# 247742	Leiden
Netherlands	St. Antonius Ziekenhuis /ID# 248644	Nieuwegein
Netherlands	Canisius-Wilhelmina Ziekenhuis /ID# 248138	Nijmegen
Netherlands	Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139	Rotterdam	Zuid-Holland
New Zealand	Palmerston North Hospital /ID# 232352	Palmerston North	Manawatu-Wanganui
New Zealand	Aotearoa Clinical Trials /ID# 228509	Papatoetoe	Auckland
New Zealand	North Shore Hospital /ID# 228508	Takapuna	Auckland
Poland	Pratia MCM Kraków /ID# 229121	Cracow
Poland	Szpitale Pomorskie Sp. z o.o /ID# 229122	Gdynia	Pomorskie
Poland	Swietokrzyskie Centrum Onkologii /ID# 229362	Kielce	Swietokrzyskie
Poland	ARS-MEDICAL Sp. z o.o. /ID# 229601	Pila	Wielkopolskie
Poland	Centrum Medyczne Promed - Skorzewo /ID# 229299	Skorzewo	Wielkopolskie
Puerto Rico	Pan American Center for Oncology Trials, LLC /ID# 230055	Rio Piedras
Slovakia	Narodny onkologicky ustav /ID# 239510	Bratislava	Bratislavsky Kraj
South Africa	University of Cape Town /ID# 228900	Cape Town	Western Cape
South Africa	Wits Clinical Research /ID# 228895	Johannesburg	Gauteng
South Africa	Haemalife Inc. /ID# 243392	Kuilsrivier	Western Cape
South Africa	Alberts Cellular Therapy /ID# 228896	Pretoria	Gauteng
Spain	Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108	Badalona	Barcelona
Spain	Hospital Parc de Salut del Mar /ID# 228106	Barcelona
Spain	Hospital Santa Creu i Sant Pau /ID# 229859	Barcelona
Spain	Hospital San Pedro de Alcantara /ID# 248845	Caceres
Spain	Hospital Universitario Reina Sofia /ID# 228122	Córdoba	Cordoba
Spain	Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 228107	L'Hospitalet de Llobregat	Barcelona
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 228109	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 228110	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 228113	Madrid
Spain	MD Anderson Madrid /ID# 229860	Madrid
Spain	Clinica Universidad de Navarra - Pamplona /ID# 228116	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca /ID# 228117	Salamanca
Spain	Hospital Universitario Marques de Valdecilla /ID# 228984	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio /ID# 228118	Sevilla
Sweden	Sodra Alvsborgs sjukhus /ID# 228886	Boras	Vastra Gotalands Lan
Sweden	Linkoping University Hospital /ID# 233520	Linkoping
Sweden	Sunderby sjukhus /ID# 228165	Lulea	Norrbottens Lan
Switzerland	Kantonsspital Aarau AG /ID# 229113	Aarau	Aargau
Switzerland	EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922	Bellinzona	Ticino
Switzerland	Kantonsspital Graubunden /ID# 253862	Chur	Graubuenden
Switzerland	Kantonsspital St. Gallen /ID# 229117	St. Gallen	Sankt Gallen
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 227384	Kaohsiung City	Kaohsiung
Taiwan	China Medical University Hospital /ID# 227379	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 227383	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 227381	Tainan
Turkey	Ankara Universitesi Fakultesi /ID# 227790	Ankara
Turkey	Akdeniz Universitesi Tip Fakul /ID# 227791	Antalya
Turkey	Dicle Universitesi Tip /ID# 230087	Diyarbakir
Turkey	Istanbul Florence Nightingale Hastanesi /ID# 229546	Istanbul
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 248202	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855	Istanbul
Turkey	Ege University Medical Faculty /ID# 227792	Izmir
Turkey	Kocaeli University Med Faculty /ID# 227854	Kocaeli
Turkey	Ondokuz mayis University Facul /ID# 227794	Samsun
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 230043	Birmingham
United Kingdom	East Suffolk and North Essex NHS Foundation Trust /ID# 230040	Colchester
United Kingdom	NHS Greater Glasgow and Clyde /ID# 230027	Glasgow	Scotland
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 230471	Leeds
United Kingdom	Clatterbridge Cancer Centre - Liverpool /ID# 230036	Liverpool
United Kingdom	Barts Health NHS Trust /ID# 230028	London	London, City Of
United Kingdom	The Christie Hospital /ID# 230124	Manchester
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123	Newcastle upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 230035	Oxford	Oxfordshire
United Kingdom	Derriford Hospital and the Royal Eye Infirmary /ID# 230038	Plymouth	Devon
United Kingdom	Portsmouth Hospitals University NHS Trust /ID# 230044	Portsmouth
United States	Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220	Billings	Montana
United States	Massachusetts General Hospital /ID# 245233	Boston	Massachusetts
United States	St. Luke's Hospital - Chesterfield /ID# 247817	Chesterfield	Missouri
United States	Northwestern University Feinberg School of Medicine /ID# 227248	Chicago	Illinois
United States	Goshen Center for Cancer Care /ID# 227189	Goshen	Indiana
United States	Community Health Network, Inc. /ID# 259756	Indianapolis	Indiana
United States	Long Beach Memorial Medical Ct /ID# 228997	Long Beach	California
United States	University of Southern California /ID# 227195	Los Angeles	California
United States	NYU Langone Hospital - Long Island /ID# 253343	Mineola	New York
United States	Morristown Medical Center /ID# 231427	Morristown	New Jersey
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193	New York	New York
United States	NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322	New York	New York
United States	University of Arizona Cancer Center - North Campus /ID# 228862	Tucson	Arizona
United States	UMass Memorial Medical Center /ID# 227323	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Genmab	AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).	Up to approximately 5 years
Secondary	Percentage of Participants Achieving Complete Response (CR)	Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.	Up to approximately 5 years
Secondary	Overall Survival (OS)	Overall survival is defined as the duration from the date of randomization to the date of the participant's death.	Up to approximately 8 years from randomization
Secondary	Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity	MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.	Up to approximately 5 years

External Links

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