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
EPCORE FL-1
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)
2 other identifiers
interventional
549
29 countries
270
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2022
Longer than P75 for phase_3
270 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedStudy Start
First participant enrolled
September 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
July 28, 2025
July 1, 2025
7.2 years
June 3, 2022
July 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Best Overall Response (BOR)
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
Up to approximately 5 years
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 Outcomes (19)
Percentage of Participants Achieving CR
Up to approximately 5 years
Overall Survival (OS)
Up to approximately 8 years from randomization
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
Up to approximately 5 years
Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Up to approximately 8 years
PFS as Assessed by Investigator
Up to approximately 5 years
- +14 more secondary outcomes
Study Arms (3)
Epcoritamab Dose A in Combination With R2
EXPERIMENTALParticipants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Epcoritamab Dose B in Combination With R2
EXPERIMENTALParticipants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
Lenalidomide and Rituximab (R2)
ACTIVE COMPARATORParticipants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
Interventions
Subcutaneous Injection
Intravenous Infusion
Oral Capsules
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (273)
The University of Arizona Cancer Center - North Campus /ID# 228862
Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences /ID# 227198
Little Rock, Arkansas, 72205, United States
Alta Bates Summit Medical Center for Research /ID# 229428
Berkeley, California, 94705, United States
Beverly Hills Cancer Center /ID# 231535
Beverly Hills, California, 90211, United States
Long Beach Memorial Medical Ct /ID# 228997
Long Beach, California, 90806-1701, United States
University of Southern California /ID# 227195
Los Angeles, California, 90033, United States
Valkyrie Clinical Trials /ID# 268502
Los Angeles, California, 90067, United States
Duplicate_Emory University /ID# 227299
Atlanta, Georgia, 30322-1013, United States
Hawaii Cancer Care - Waterfront Plaza /ID# 262448
Honolulu, Hawaii, 96813-4920, United States
Northwestern University Feinberg School of Medicine /ID# 227248
Chicago, Illinois, 60611-2927, United States
Goshen Center for Cancer Care /ID# 227189
Goshen, Indiana, 46526, United States
Community Health Network, Inc. /ID# 259756
Indianapolis, Indiana, 46250-2042, United States
Our Lady Of The Lake Regional Medical Center /ID# 251393
Baton Rouge, Louisiana, 70808, United States
University of Maryland, Baltimore /ID# 227191
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital /ID# 245233
Boston, Massachusetts, 02114, United States
UMass Memorial Medical Center /ID# 227323
Worcester, Massachusetts, 01605, United States
Henry Ford Hospital /ID# 227250
Detroit, Michigan, 48202, United States
St. Luke's Hospital - Chesterfield /ID# 247817
Chesterfield, Missouri, 63017, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
Billings, Montana, 59102, United States
Morristown Medical Center /ID# 231427
Morristown, New Jersey, 07960-6136, United States
Roswell Park Cancer Institute /ID# 239128
Buffalo, New York, 14263, United States
NYU Langone Hospital - Long Island /ID# 253343
Mineola, New York, 11501, United States
NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai /ID# 227181
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
New York, New York, 10065-6007, United States
East Carolina University - Brody School of Medicine /ID# 227192
Greenville, North Carolina, 27834, United States
University of Oklahoma, Stephenson Cancer Center /ID# 227325
Oklahoma City, Oklahoma, 73104-5418, United States
Baylor Sammons Cancer Center /ID# 261584
Dallas, Texas, 75246, United States
Texas Oncology - Northeast Texas /ID# 265890
Tyler, Texas, 75702, United States
Intermountain Healthcare LDS Hospital /ID# 259948
Salt Lake City, Utah, 84143, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 227211
Richmond, Virginia, 23219, United States
Fundaleu /Id# 229700
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1114, Argentina
Duplicate_CEMIC /ID# 229697
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1431, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701
Córdoba, Córdoba Province, 5016, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124
Santa Fe, Santa Fe Province, 3000, Argentina
Royal Prince Alfred Hospital /ID# 239272
Camperdown, New South Wales, 2050, Australia
Nepean Hospital /ID# 239093
Kingswood, New South Wales, 2747, Australia
Townsville University Hospital /ID# 231124
Douglas, Queensland, 4814, Australia
Peninsula Private Hospital /ID# 238796
Frankston, Victoria, 3199, Australia
Fiona Stanley Hospital /ID# 231122
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital /ID# 230456
Perth, Western Australia, 6000, Australia
Hollywood Private Hospital /ID# 251789
Perth, Western Australia, 6009, Australia
Universitaetsklinikum St. Poelten /ID# 234015
Sankt Pölten, Lower Austria, 3100, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366
Salzburg, Salzburg, 5020, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
Linz, Upper Austria, 4010, Austria
Uza /Id# 228521
Edegem, Antwerpen, 2650, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 228520
La Louvière, Hainaut, 7100, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 230415
Liège, Liege, 4000, Belgium
Vitaz /Id# 228525
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Universitair Ziekenhuis Leuven /ID# 247780
Leuven, Vlaams-Brabant, 3000, Belgium
Institut Jules Bordet /ID# 254676
Anderlecht, 1070, Belgium
AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
Turnhout, 2300, Belgium
Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
Curitiba, Paraná, 80060-900, Brazil
Instituto Nacional de Cancer (INCA) /ID# 228706
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
Upeclin Fmb - Unesp /Id# 252912
Botucatu, São Paulo, 18618-686, Brazil
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129
Jaú, São Paulo, 17210-070, Brazil
Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121
São Paulo, São Paulo, 01323-001, Brazil
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918
São Paulo, São Paulo, 01401-002, Brazil
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130
São Paulo, São Paulo, 01509-900, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182
São Paulo, São Paulo, 04039-901, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127
São Paulo, São Paulo, 05403-000, Brazil
Cross Cancer Institute /ID# 249080
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer - Victoria /ID# 228850
Victoria, British Columbia, V8R 6V5, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896
Lévis, Quebec, G6V 3Z1, Canada
CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537
Québec, Quebec, G1J 1Z4, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 229894
Rimouski, Quebec, G5L 5T1, Canada
Peking University First Hospital /ID# 250517
Beijing, Beijing Municipality, 100034, China
Peking University Third Hospital /ID# 230885
Beijing, Beijing Municipality, 100191, China
Fujian Medical University Union Hospital /ID# 233919
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University /ID# 238427
Xiamen, Fujian, 361003, China
Sun Yat-Sen University Cancer Center /ID# 231463
Guangzhou, Guangdong, 510060, China
Guangdong Provincial Peoples Hospital（Huifu Campus） /ID# 232512
Guangzhou, Guangdong, 510120, China
Nanfang Hospital of Southern Medical University /ID# 230383
Guangzhou, Guangdong, 510515, China
Fourth Hospital of Hebei Medical University /ID# 238657
Shijiazhuang, Hebei, 050011, China
Henan Cancer Hospital /ID# 230459
Zhengzhou, Henan, 450008, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital /ID# 232255
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital /ID# 232153
Changsha, Hunan, 410006, China
The First Affiliated Hospital of Soochow University /ID# 232511
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical College /ID# 232513
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Nanchang University /ID# 231047
Nanchang, Jiangxi, 330006, China
Jiangxi Provincial Cancer Hospital /ID# 232507
Nanchang, Jiangxi, 330029, China
The First Hospital of China Medical University /ID# 232509
Shenyang, Liaoning, 110001, China
Xijing Hospital /ID# 238650
Xi'an, Shaanxi, 710032, China
Fudan University Cancer Hospital /ID# 250475
Shanghai, Shanghai Municipality, 200032, China
Tianjin Cancer Hospital /ID# 230876
Tianjin, Tianjin Municipality, 300000, China
Yunnan Cancer Hospital /ID# 232062
Kunming, Yunnan, 650118, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390
Hangzhou, Zhejiang, 310003, China
The second affiliated hospital of Zhejiang University school of medicine /ID# 231250
Hangzhou, Zhejiang, 310009, China
Zhejiang Cancer hospital /ID# 231389
Hangzhou, Zhejiang, 310022, China
Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269
Hradec Králové, Hradec Kralove, 500 05, Czechia
Všeobecná Fakultní Nemocnice v Praze /ID# 228565
Prague, Praha 17, 128 00, Czechia
Fakultni nemocnice Kralovske Vinohrady /ID# 228564
Prague, 100 34, Czechia
Duplicate_Fakultni Nemocnice v Motole /ID# 228272
Prague, 150 00, Czechia
Regionshospitalet Godstrup /ID# 227466
Herning, Central Jutland, 7400, Denmark
Sygehus Lillebalt, Vejle /ID# 227404
Vejle, Region Syddanmark, 7100, Denmark
CHU Clermont-Ferrand /ID# 238676
Clermont, Auvergne-Rhône-Alpes, 63100, France
CHU de Rennes - PONTCHAILLOU /ID# 230356
Rennes, Brittany Region, 35000, France
CHU Dijon /ID# 230354
Dijon, Cote-d Or, 21000, France
CHU Limoges - Dupuytren 1 /ID# 231450
Limoges, Franche-Comte, 87042, France
CHU NIMES - Hopital Caremeau /ID# 230351
Nîmes, Gard, 30029, France
Centre Hospitalier Universitaire de Bordeaux /ID# 230347
Pessac, Gironde, 33604, France
CHU Reims - Hôpital Robert Debre /ID# 248710
Reims, Marne, 51092, France
CHRU Nancy - Hopitaux de Brabois /ID# 241595
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
CHRU Lille - Hopital Claude Huriez /ID# 230353
Lille, Nord, 59037, France
IUCT Oncopole /ID# 233486
Toulouse, Occitanie, 31059, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 230358
Créteil, Paris, 94010, France
Hôpital Saint-Louis /ID# 232067
Paris, Paris, 75010, France
CHU de Nantes, Hotel Dieu -HME /ID# 245928
Nantes, Pays de la Loire Region, 44000, France
Centre Leon Berard /ID# 230348
Lyon, Rhone, 69373, France
HCL - Hopital Lyon Sud /ID# 231449
Pierre-Bénite, Rhone, 69495, France
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095
La Roche-sur-Yon, Vendee, 85000, France
CHU Poitiers - La miletrie /ID# 230357
Poitiers, Vienne, 86000, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
Caen, 14033, France
Hopital Pitie Salpetriere /ID# 230360
Paris, Île-de-France Region, 75013, France
Universitaetsklinikum Tuebingen /ID# 229663
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Wuerzburg /ID# 229278
Würzburg, Bavaria, 97080, Germany
Universitaetsklinikum Giessen /ID# 234245
Giessen, Hesse, 35392, Germany
Klinikum Kassel /ID# 229185
Kassel, Hesse, 34125, Germany
Universitaetsmedizin Goettingen /ID# 230411
Göttingen, Lower Saxony, 37075, Germany
Universitaetsklinikum Bonn /ID# 249401
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 229754
Dresden, Saxony, 01307, Germany
Universitaetsklinikum Leipzig /ID# 242907
Leipzig, Saxony, 04103, Germany
Otto-von-Guericke-Universitaet /ID# 230144
Magdeburg, Saxony-Anhalt, 39120, Germany
Helios Klinikum Berlin-Buch /ID# 229178
Berlin, State of Berlin, 13125, Germany
Universitaetsklinikum Jena /ID# 232064
Jena, Thuringia, 07747, Germany
Sozialstiftung Bamberg /ID# 229184
Bamberg, 96049, Germany
Universitaetsklinikum Essen /ID# 229180
Essen, 45147, Germany
Klinikum Mutterhaus der Borromäerinnen /ID# 232354
Trier, 54290, Germany
General Hospital of Athens Laiko /ID# 226626
Athens, Attica, 11527, Greece
Alexandra General Hospital /ID# 226632
Athens, Attica, 11528, Greece
University General Hospital Attikon /ID# 226629
Athens, Attica, 12462, Greece
University General Hospital of Ioannina /ID# 226628
Ioannina, Ioannina, 45500, Greece
General University Hospital of Thessaloniki AXEPA /ID# 226630
Thessaloniki, Thessaloniki, 54636, Greece
Theageneio Anticancer Hospital /ID# 226627
Thessaloniki, Thessaloniki, 54639, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633
Athens, 10676, Greece
Semmelweis Egyetem /ID# 229291
Budapest, Budapest, 1085, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286
Budapest, Budapest, 1097, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 229287
Debrecen, Hajdú-Bihar, 4032, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475
Kaposvár, Somogy County, 7400, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Szegedi Tudományegyetem /ID# 229289
Szeged, Szeged, 6720, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290
Szombathely, Vas County, 9700, Hungary
Orszagos Onkologiai Intezet /ID# 229292
Budapest, 1122, Hungary
Yitzhak Shamir Medical Center /ID# 228037
Ẕerifin, Central District, 70300, Israel
Rambam Health Care Campus /ID# 227849
Haifa, Haifa District, 3109601, Israel
Hadassah /ID# 227846
Jerusalem, Jerusalem, 91120, Israel
ZIV Medical Center /ID# 232257
Safed, Northern District, 13100, Israel
The Chaim Sheba Medical Center /ID# 228322
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 228529
Tel Aviv, Tel Aviv, 6423906, Israel
Rabin Medical Center /ID# 228043
Petah Tikva, 4941492, Israel
Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 227401
Alessandria, Alessandria, 15100, Italy
Duplicate_I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400
Bari, Bari, 70124, Italy
ASST degli Spedali Civili di Brescia /ID# 227397
Brescia, Brescia, 25123, Italy
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458
San Giovanni Rotondo, Foggia, 71013, Italy
IRCCS Ospedale San Raffaele /ID# 228669
Milan, Milano, 20132, Italy
Istituto Europeo Di Oncologia /ID# 227396
Milan, Milano, 20141, Italy
Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 230403
Napoli, Napoli, 80131, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 227402
Palermo, Palermo, 90146, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229820
Turin, Piedmont, 10126, Italy
Duplicate_Centro di Riferimento Oncologico /ID# 227395
Aviano, Pordenone, 33081, Italy
Ospedale Santa Maria Delle Croci /ID# 227394
Ravenna, Ravenna, 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402
Rome, Roma, 00168, Italy
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602
Candiolo, Torino, 10060, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399
Novara, 28100, Italy
Duplicate_NHO Nagoya Medical Center /ID# 230678
Nagoya, Aichi-ken, 460-0001, Japan
Aichi Cancer Center Hospital /ID# 230134
Nagoya, Aichi-ken, 464-8681, Japan
Fujita Health University Hospital /ID# 264541
Toyoake, Aichi-ken, 470-1192, Japan
National Cancer Center Hospital East /ID# 232423
Kashiwa-shi, Chiba, 277-8577, Japan
Matsuyama Red Cross Hospital /ID# 251866
Matsuyama, Ehime, 790-8524, Japan
National Hospital Organization Kyushu Cancer Center /ID# 252245
Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital /ID# 230136
Fukuoka, Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital /ID# 251839
Fukushima, Fukushima, 960-1295, Japan
Hokkaido University Hospital /ID# 231443
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital /ID# 251945
Kobe, Hyōgo, 650-0047, Japan
Kagoshima University Hospital /ID# 232251
Kagoshima, Kagoshima-ken, 890-8520, Japan
Tokai University Hospital /ID# 252135
Isehara, Kanagawa, 259-1193, Japan
Kitasato University Hospital /ID# 264668
Sagamihara-shi, Kanagawa, 252-0375, Japan
Kyoto University Hospital /ID# 231156
Kyoto, Kyoto, 606-8507, Japan
Mie University Hospital /ID# 251944
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital /ID# 232303
Sendai, Miyagi, 9808574, Japan
Shinshu University Hospital /ID# 252246
Matsumoto-shi, Nagano, 390-8621, Japan
Okayama University Hospital /ID# 232009
Okayama, Okayama-ken, 700-8558, Japan
Osaka City General Hospital /ID# 264670
Osaka, Osaka, 534-0021, Japan
Kindai University Hospital /ID# 232152
Osakasayama-shi, Osaka, 589-8511, Japan
National Cancer Center Hospital /ID# 230004
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 230271
Koto-ku, Tokyo, 135-8550, Japan
Yamagata University Hospital /ID# 230005
Yamagata, Yamagata, 990-9585, Japan
Yamanashi Prefectural Central Hospital /ID# 263715
Kofu, Yamanashi, 400-0027, Japan
Canisius-Wilhelmina Ziekenhuis /ID# 248138
Nijmegen, Gelderland, 6532 SZ, Netherlands
Amphia Ziekenhuis /ID# 247739
Breda, North Brabant, 4818 CK, Netherlands
Olvg /Id# 247899
Amsterdam, North Holland, 1091 AC, Netherlands
Dijklander Ziekenhuis /ID# 248993
Hoorn, North Holland, 1624 NP, Netherlands
Medisch Spectrum Twente /ID# 247854
Enschede, Overijssel, 7512 KZ, Netherlands
Universitair Medisch Centrum Groningen /ID# 247741
Groningen, Provincie Groningen, 9713 GZ, Netherlands
Albert Schweitzer Ziekenhuis /ID# 247740
Dordrecht, South Holland, 3318 AT, Netherlands
Leids Universitair Medisch Centrum /ID# 247742
Leiden, South Holland, 2333 ZA, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139
Rotterdam, South Holland, 3045 PM, Netherlands
St. Antonius Ziekenhuis /ID# 248644
Nieuwegein, Utrecht, 3435 CM, Netherlands
Admiraal de Ruyter Ziekenhuis /ID# 247692
Goes, Zeeland, 4462 RA, Netherlands
Deventer Ziekenhuis /ID# 247853
Deventer, 7416 SE, Netherlands
Aotearoa Clinical Trials /ID# 228509
Papatoetoe, Auckland, 2025, New Zealand
North Shore Hospital /ID# 228508
Takapuna, Auckland, 0622, New Zealand
Palmerston North Hospital /ID# 232352
Palmerston North, Manawatu-Wanganui, 4442, New Zealand
ARS-MEDICAL Sp. z o.o. /ID# 229601
Piła, Greater Poland Voivodeship, 64-920, Poland
Aidport Sp. z o.o. /ID# 229299
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Pratia MCM Krakow /ID# 229121
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Szpitale Pomorskie Sp. z o.o /ID# 229122
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Hematology and Oncology Institute /ID# 230056
Manatí, Puerto Rico, 00674, Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 230055
Rio Piedras, Puerto Rico, 00935, Puerto Rico
Auxilio Mutuo Cancer Center /ID# 248721
San Juan, Puerto Rico, 00918, Puerto Rico
Narodny onkologicky ustav /ID# 239510
Bratislava, Bratislava Region, 833 10, Slovakia
Wits Clinical Research /ID# 228895
Johannesburg, Gauteng, 1864, South Africa
Alberts Cellular Therapy /ID# 228896
Pretoria, Gauteng, 0044, South Africa
University of Cape Town /ID# 228900
Cape Town, Western Cape, 7925, South Africa
Haemalife Inc. /ID# 243392
Kuils River, Western Cape, 7580, South Africa
Inje University - Busan Paik Hospital /ID# 230293
Busan, Busan Gwang Yeogsi, 47392, South Korea
Dong-A University Medical Center /ID# 228638
Busan, Busan Gwang Yeogsi, 49201, South Korea
Pusan National University Hospital /ID# 229798
Busan, Busan Gwang Yeogsi, 49241, South Korea
Seoul National University Bundang Hospital /ID# 228448
Seongnam-si, Gyeonggido, 13620, South Korea
Keimyung University Dongsan Hospital /ID# 229800
Daegu, Gyeongsangbuk-do, 42601, South Korea
Jeonbuk National University Hospital /ID# 228908
Jeonju, Jeonrabugdo, 54907, South Korea
Seoul National University Hospital /ID# 228446
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center /ID# 228444
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 228445
Seoul, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108
Badalona, Barcelona, 08916, Spain
Hospital Parc de Salut del Mar /ID# 228106
Barcelona, Barcelona, 08003, Spain
Hospital Santa Creu i Sant Pau /ID# 229859
Barcelona, Barcelona, 08041, Spain
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 228107
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital San Pedro de Alcantara /ID# 248845
Cáceres, Caceres, 10003, Spain
Hospital Universitario Marques de Valdecilla /ID# 228984
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofia /ID# 228122
Córdoba, Cordoba, 14004, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157
Madrid, Madrid, 28027, Spain
MD Anderson Madrid /ID# 229860
Madrid, Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal /ID# 228113
Madrid, Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 228110
Madrid, Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 228109
Madrid, Madrid, 28041, Spain
Clinica Universidad de Navarra - Pamplona /ID# 228116
Pamplona, Navarre, 31008, Spain
Hospital Universitario de Salamanca /ID# 228117
Salamanca, Salamanca, 37711, Spain
Hospital Universitario Virgen del Rocio /ID# 228118
Seville, Sevilla, 41013, Spain
Sunderby sjukhus /ID# 228165
Luleå, Norrbotten County, 971 80, Sweden
Sodra Alvsborgs sjukhus /ID# 228886
Borås, Västra Götaland County, 501 82, Sweden
Linkoping University Hospital /ID# 233520
Linköping, Östergötland County, 581 85, Sweden
Kantonsspital Aarau AG /ID# 229113
Aarau, Canton of Aargau, 5001, Switzerland
Kantonsspital St. Gallen /ID# 229117
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922
Bellinzona, Canton Ticino, 6500, Switzerland
Kantonsspital Graubünden /ID# 253862
Chur, Kanton Graubünden, 7000, Switzerland
Kaohsiung Chang Gung Memorial Hospital /ID# 227384
Kaohsiung City, Kaohsiung, 833, Taiwan
China Medical University Hospital /ID# 227379
Taichung, Taichung, 40447, Taiwan
Taichung Veterans General Hospital /ID# 227383
Taichung, Taichung, 40705, Taiwan
National Cheng Kung University Hospital /ID# 227381
Tainan, Tainan, 704, Taiwan
Ankara Universitesi Fakultesi /ID# 227790
Ankara, Ankara, 06620, Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 248202
Istanbul, Istanbul, 34098, Turkey (Türkiye)
Istanbul Florence Nightingale Hastanesi /ID# 229546
Istanbul, Istanbul, 34200, Turkey (Türkiye)
Duplicate_Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855
Istanbul, Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty /ID# 227792
Izmir, İzmir, 35040, Turkey (Türkiye)
Kocaeli University Med Faculty /ID# 227854
Köseköy, Kocaeli, 41380, Turkey (Türkiye)
Ondokuz mayis University Facul /ID# 227794
Samsun, Samsun, 55200, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakul /ID# 227791
Antalya, 07059, Turkey (Türkiye)
Dicle Universitesi Tip /ID# 230087
Diyarbakır, 21200, Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust /ID# 230043
Birmingham, Birmingham, B15 2TH, United Kingdom
Derriford Hospital and the Royal Eye Infirmary /ID# 230038
Plymouth, Devon, PL6 8DH, United Kingdom
Gartnavel General Hospital /ID# 230027
Glasgow, Glasgow City, G12 0YN, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 230028
London, Greater London, E1 2ES, United Kingdom
Clatterbridge Cancer Centre - Liverpool /ID# 230036
Liverpool, Liverpool, L7 8YA, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123
Newcastle upon Tyne, Newcastle upon Tyne, NE3 3HD, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 230035
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 230471
Leeds, West Yorkshire, LS9 7TF, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 230040
Colchester, CO4 5JL, United Kingdom
The Christie Hospital /ID# 230124
Manchester, M20 4BX, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 230044
Portsmouth, PO6 3LY, United Kingdom
Related Publications (1)
Falchi L, Nijland M, Huang H, Linton KM, Seymour JF, Tao R, Kwiatek M, Costa A, Vassilakopoulos TP, Greil R, Jimenez-Ubieto A, Gangatharan SA, Benjamini O, Thieblemont C, Tucci A, Elinder-Camburn A, Illes A, Novak J, Pavlovsky MA, McDonald A, Yoon DH, Maruyama D, Sunkersett G, Mei JP, Mukherjee N, Zhu F, Alshreef A, Favaro E, Morschhauser F; EPCORE FL-1 Investigators. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. 2026 Jan 10;407(10524):161-173. doi: 10.1016/S0140-6736(25)02360-8. Epub 2025 Dec 7.
PMID: 41371238DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2022
First Posted
June 8, 2022
Study Start
September 20, 2022
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.