AzTrials
AzTrials

Follicular Lymphoma (FL)Phase 3EPCORE™FL-2NCT06191744

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 Previously Untreated Follicular Lymphoma

A Phase 3 study testing Epcoritamab, Prednisone and Rituximab in people with Follicular Lymphoma (FL), run by Genmab at 266 sites in 32 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma (FL)
What is being tested?
Epcoritamab, Prednisone and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,095 participants
Where
266 sitesin 32 countries
Study dates
5 Feb 2024to Nov 2037
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of follicular lymphoma (FL).
  • Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
  • Are willing and able to comply with procedures required in the protocol.
  • Must have stage, III, IV or II with bulky disease >= 7cm).
  • Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
  • Has one or more target lesions:
Show all 11Show fewer
  • A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
  • >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
  • Have laboratory values meeting the criteria in the protocol.

Who cannot join

  • Had major surgery within 4 weeks prior to randomization.
  • Have active cytomegalovirus (CMV) disease.

Trial locations and contacts

266 sites in 32 countries.

266 sites in 32 countries

United States58 sites

  • New York Oncology Hematology - Albany Cancer Center /ID# 261814

    Albany, New York, 12206-5013

  • University of New Mexico /ID# 261083

    Albuquerque, New Mexico, 87102-4517

  • Presbyterian Kaseman Hospital /ID# 262451

    Albuquerque, New Mexico, 87110

  • Texas Oncology - Austin Midtown /ID# 261208

    Austin, Texas, 78705

  • University of Maryland, Baltimore /ID# 259538

    Baltimore, Maryland, 21201

  • Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476

    Bethesda, Maryland, 20817

  • Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006

    Billings, Montana, 59102

  • Rocky Mountain Cancer Centers - Boulder /ID# 261203

    Boulder, Colorado, 80303

  • MUSC Hollings Cancer Center /ID# 259604

    Charleston, South Carolina, 29425

  • Novant Health Presbyterian Medical Center /ID# 259740

    Charlotte, North Carolina, 28204

  • St. Luke's Hospital - Chesterfield /ID# 260489

    Chesterfield, Missouri, 63017

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814

    Chicago, Illinois, 60611

  • Oncology Hematology Care, Inc - Blue Ash /ID# 261204

    Cincinnati, Ohio, 45252

  • Beacon Cancer Care - Coeur d'Alene /ID# 260670

    Coeur d'Alene, Idaho, 83814

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206

    Dallas, Texas, 75246-2003

  • Cancer Care Specialists Of Central Illinois /ID# 272464

    Decatur, Illinois, 62526

  • University of Iowa Health Care /ID# 262132

    Des Moines, Iowa, 50314-3017

  • Swedish Cancer Institute - Edmonds /ID# 266356

    Edmonds, Washington, 98026

  • Oncology Associates of Oregon, P.C. /ID# 261816

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists - Fairfax /ID# 261205

    Fairfax, Virginia, 22031

  • Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583

    Fort Wayne, Indiana, 46804

  • UCSF Fresno /ID# 264712

    Fresno, California, 93701-2302

  • Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506

    Grand Island, Nebraska, 68803

  • Prisma Health /ID# 259602

    Greenville, South Carolina, 29605

  • MD Anderson Cancer Center /ID# 260984

    Houston, Texas, 77030-4000

  • Oncology Consultants /ID# 268390

    Houston, Texas, 77030

  • Swedish Cancer Institute - Issaquah /ID# 266358

    Issaquah, Washington, 98029

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445

    Jacksonville, Florida, 32256

  • Nebraska Hematology-Oncology /ID# 269692

    Lincoln, Nebraska, 68506

  • University of Louisville Hospital /ID# 260544

    Louisville, Kentucky, 40202

  • Norton Cancer Institute - St. Matthews /ID# 261076

    Louisville, Kentucky, 40207

  • Joe Arrington Cancer Research /ID# 260382

    Lubbock, Texas, 79410

  • Taylor Cancer Research Center /ID# 260488

    Maumee, Ohio, 43537-1921

  • Loyola University /ID# 259462

    Maywood, Illinois, 60153

  • NYU Langone Hospital - Long Island /ID# 265531

    Mineola, New York, 11501

  • Sarah Cannon Research Institute - Tristar Centennial Medical Center /ID# 274985

    Nashville, Tennessee, 37203

  • NYU Langone Medical Center /ID# 264518

    New York, New York, 10016-6402

  • Icahn School of Medicine at Mount Sinai /ID# 259595

    New York, New York, 10029

  • Christiana Care Health Service /ID# 261207

    Newark, Delaware, 19713

  • Vista Oncology - East Olympia /ID# 261360

    Olympia, Washington, 98506-5028

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505

    Omaha, Nebraska, 68130

  • University of Nebraska Medical Center /ID# 261996

    Omaha, Nebraska, 68198

  • Advent Health /ID# 261578

    Orlando, Florida, 32803

  • Orlando Health Cancer Institute /ID# 260983

    Orlando, Florida, 32806

  • Illinois Cancer Care, PC /ID# 261526

    Peoria, Illinois, 61615

  • Presbyterian Rust Medical Center /ID# 262447

    Rio Rancho, New Mexico, 87124

  • Oncology and Hematology Associates of Southwest Virginia /ID# 261592

    Roanoke, Virginia, 98684

  • Intermountain Healthcare LDS Hospital /ID# 259759

    Salt Lake City, Utah, 84143

  • Scripps Mercy Hospital /ID# 265393

    San Diego, California, 92103

  • Sansum Clinic Research /ID# 261596

    Santa Barbara, California, 93105

  • Virginia Mason Hospital and Medical Center /ID# 260549

    Seattle, Washington, 98101

  • Swedish Medical Center - Seattle /ID# 260370

    Seattle, Washington, 98104

  • Northwest Medical Specialties - Tacoma /ID# 262133

    Tacoma, Washington, 98405

  • Moffitt Cancer Center /ID# 259487

    Tampa, Florida, 33612-9416

  • New York Oncology Hematology /ID# 270208

    Troy, New York, 12180

  • New England Cancer Specialists - Westbrook /ID# 260672

    Westbrook, Maine, 04092

  • Clinical Research Alliance - Westbury /ID# 261078

    Westbury, New York, 11590

  • Novant Health Forsyth Medical Center /ID# 259741

    Winston-Salem, North Carolina, 27103

Other trials in United States

China28 sites

  • Peking University First Hospital /ID# 259816

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital /ID# 259806

    Beijing, Beijing Municipality, 100191

  • Hunan Cancer Hospital /ID# 260439

    Changsha, Hunan, 410006

  • West China Hospital, Sichuan University /ID# 260015

    Chengdu, Sichuan, 610041

  • Sun Yat-Sen University Cancer Center /ID# 260478

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial Peoples Hospital /ID# 260446

    Guangzhou, Guangdong, 510080

  • Zhujiang Hospital of Southern Medical University /ID# 260558

    Guangzhou, Guangdong, 510280

  • Nanfang Hospital of Southern Medical University /ID# 260795

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 259744

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer hospital /ID# 259742

    Hangzhou, Zhejiang, 310022

  • Shandong Cancer Hospital /ID# 260808

    Jinan, Shandong, 251601

  • Yunnan Cancer Hospital /ID# 260645

    Kunming, Yunnan, 650118

  • The First Affiliated Hospital of Nanchang University /ID# 260556

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Cancer Hospital /ID# 260559

    Nanchang, Jiangxi, 330029

  • Affiliated Cancer Hospital of Guangxi Medical University /ID# 260537

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center /ID# 260564

    Shanghai, Shanghai Municipality, 200032

  • First Affiliated Hospital of China Medical University /ID# 260217

    Shenyang, Liaoning, 110001

  • Shenzhen People's Hospital /ID# 260137

    Shenzhen, Guangdong, 518020

  • The First Affiliated Hospital of Soochow University /ID# 260507

    Suzhou, Jiangsu, 215006

  • Tianjin Cancer Hospital /ID# 259807

    Tianjin, Tianjin Municipality, 300000

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259616

    Tianjin, Tianjin Municipality, 300020

  • The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 260644

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 260566

    Wenzhou, Zhejiang, 325000

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 259743

    Wuhan, Hubei, 430048

  • Hubei Cancer Hospital /ID# 260506

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University /ID# 260014

    Xiamen, Fujian, 361003

  • People's Hospital of Henan Province /ID# 259619

    Zhengzhou, Henan, 450003

  • Henan Cancer Hospital /ID# 259618

    Zhengzhou, Henan, 450008

Other trials in China

Japan21 sites

  • Aomori Prefectural Central Hospital /ID# 265692

    Aomori, 030-0913

  • Tokyo Metropolitan Komagome Hospital /ID# 267692

    Bunkyo Ku, Tokyo, 113-8677

  • The University of Tokyo Hospital /ID# 266422

    Bunkyo-ku, Tokyo, 113-8654

  • Chiba Cancer Center /ID# 267316

    Chiba, 260-0801

  • University of Yamanashi Hospital /ID# 264677

    Chuo-shi, Yamanashi, 409-3898

  • National Hospital Organization Kyushu Cancer Center /ID# 265960

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital /ID# 267861

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University /ID# 264994

    Fukushima, 960-1295

  • Chugoku Central Hospital /ID# 266520

    Fukuyama, Hiroshima, 720-0001

  • Kansai Medical University Hospital /ID# 266019

    Hirakata-shi, Osaka, 573-1191

  • Hitachi General Hospital /ID# 265676

    Hitachi-shi, Ibaraki, 317-0077

  • Kobe City Medical Center General Hospital /ID# 266379

    Kobe, Hyōgo, 650-0047

  • Matsuyama Red Cross Hospital /ID# 266426

    Matsuyama, Ehime, 790-8524

  • Okayama University Hospital /ID# 267135

    Okayama, Okayama-ken, 700-8558

  • Kitasato University Hospital /ID# 264675

    Sagamihara-shi, Kanagawa, 252-0375

  • Kindai University Hospital /ID# 265038

    Sakai-shi, Osaka, 590-0197

  • Sapporo Medical University Hospital /ID# 265031

    Sapporo, Hokkaido, 060-8543

  • Fujita Health University Hospital /ID# 264679

    Toyoake, Aichi-ken, 470-1192

  • Yamaguchi University Hospital /ID# 265619

    Ube, Yamaguchi, 755-8505

  • Kanagawa Cancer Center /ID# 265497

    Yokohama, Kanagawa, 241-8515

  • University of Fukui Hospital /ID# 265680

    Yoshida-gun, Fukui, 910-1104

Other trials in Japan

Spain11 sites

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 260495

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall de Hebron /ID# 260490

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 260492

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau /ID# 260498

    Barcelona, 08041

  • Hospital San Pedro de Alcantara /ID# 260502

    Cáceres, 10003

  • Institut Catala dOncologia - LHospitalet /ID# 261439

    L'Hospitalet de Llobregat, Barcelona, 08907

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 261512

    Madrid, 28027

  • MD Anderson Madrid /ID# 260500

    Madrid, 28033

  • Clinica Universidad de Navarra - Pamplona /ID# 260496

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca /ID# 260491

    Salamanca, 37711

  • Hospital Universitario Marques de Valdecilla /ID# 260497

    Santander, Cantabria, 39008

Other trials in Spain

Australia10 sites

  • Royal Prince Alfred Hospital /ID# 259320

    Camperdown, New South Wales, 2050

  • Townsville University Hospital /ID# 259323

    Douglas, Queensland, 4814

  • Peninsula Private Hospital /ID# 259325

    Frankston, Victoria, 3199

  • Royal Brisbane and Women's Hospital /ID# 259326

    Herston, Queensland, 4029

  • Liverpool Hospital /ID# 259321

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Center /ID# 260431

    Melbourne, New South Wales, 3000

  • Fiona Stanley Hospital /ID# 259324

    Murdoch, Western Australia, 6150

  • Royal Perth Hospital /ID# 259319

    Perth, Western Australia, 6000

  • Westmead Hospital /ID# 261465

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital - Woolloongabba /ID# 259329

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil10 sites

  • Oncocentro de Minas Gerais /ID# 260973

    Belo Horizonte, Minas Gerais, 30360-680

  • DF Star /ID# 260844

    Brasília, Federal District, 70390-140

  • Hospital Erasto Gaertner /ID# 260871

    Curitiba, Paraná, 81520-060

  • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 260828

    Jaú, São Paulo, 17210-070

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 260843

    Ribeirão Preto, São Paulo, 14049-900

  • Grupo Oncoclinicas Botafogo /ID# 260870

    Rio de Janeiro, 22250-905

  • Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 260827

    São Paulo, São Paulo, 01509-900

  • Real e Benemérita Associação Portuguesa de Beneficência /ID# 260826

    São Paulo, 01323-001

  • Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 260829

    São Paulo, 01401-002

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 260822

    São Paulo, 05403-000

Other trials in Brazil

France10 sites

  • Hopital Prive d'Antony /ID# 260598

    Antony, Île-de-France Region, 92160

  • Centre Hospitalier D'Avignon /ID# 260511

    Avignon, Provence-Alpes-Côte d'Azur Region, 84000

  • CHU Brest - Hopital de la Cavale Blanche /ID# 260601

    Brest, Finistere, 29200

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 260875

    Caen, Calvados, 14033

  • Centre Hospitalier du Mans /ID# 260510

    Le Mans, Sarthe, 72037

  • CH Libourne - Hopital Robert Boulin /ID# 261478

    Libourne, 33500

  • Hopital Prive du Confluent /ID# 260596

    Nantes, Loire-Atlantique, 44277

  • Hopital Saint-Louis /ID# 260509

    Paris, 75010

  • HCL - Hopital Lyon Sud /ID# 260508

    Pierre-Bénite, Rhone, 69495

  • Clinique Sainte-Anne /ID# 261528

    Strasbourg, 67085

Other trials in France

Netherlands9 sites

  • Olvg /Id# 259543

    Amsterdam, North Holland, 1091 AC

  • Rijnstate /ID# 261219

    Arnhem, 6815 AD

  • Universitair Medisch Centrum Groningen /ID# 259051

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum /ID# 259049

    Leiden, South Holland, 2333 ZA

  • St. Antonius Ziekenhuis /ID# 259053

    Nieuwegein, Utrecht, 3435 CM

  • Bravis Ziekenhuis /ID# 259055

    Roosendaal, North Brabant, 4708 AE

  • Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 259052

    Rotterdam, South Holland, 3045 PM

  • HagaZiekenhuis /ID# 261220

    The Hague, South Holland, 2545 AA

  • Elisabeth Tweesteden Ziekenhuis /ID# 261239

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Belgium7 sites

  • Algemeen Ziekenhuis klina /ID# 260324

    Brasschaat, Antwerpen, 2930

  • Cliniques Universitaires UCL Saint-Luc /ID# 260311

    Brussels, Brussels Capital, 1200

  • Uza /Id# 260319

    Edegem, Antwerpen, 2650

  • UZ Gent /ID# 260312

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 260304

    Leuven, Vlaams-Brabant, 3000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 260325

    Liège, Liege, 4000

  • AZ-Delta. /ID# 260313

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Croatia7 sites

  • Klinicki bolnicki centar Rijeka /ID# 260455

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar Split /ID# 260454

    Split, Split-Dalmatia County, 21000

  • Zadar General Hospital /ID# 260837

    Zadar, 23000

  • Clinical Hospital Dubrava /ID# 260452

    Zagreb, City of Zagreb, 10000

  • Klinicka bolnica Merkur /ID# 260393

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 260456

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 260364

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Israel7 sites

  • HaEmek Medical Center /ID# 259936

    Afula, Haifa District, 1834111

  • Soroka University Medical Center /ID# 259937

    Beersheba, Southern District, 8443901

  • Hadassah /ID# 259935

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center /ID# 259938

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center. /ID# 268328

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 259934

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 259933

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Italy7 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 260886

    Bologna, 40138

  • Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 260889

    Candiolo, Torino, 10060

  • AOU Policlinico G. Rodolico - San Marco /ID# 260890

    Catania, 95123

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 260888

    Palermo, 90146

  • AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 260744

    Reggio Emilia, 42122

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 260891

    Roma, 00128

  • IRCCS Istituto Clinico Humanitas /ID# 260887

    Rozzano, Lombardy, 20089

Other trials in Italy

Germany6 sites

  • St.-Antonius-Hospital /ID# 260520

    Eschweiler, North Rhine-Westphalia, 52249

  • Universitaetsklinikum Frankfurt /ID# 260388

    Frankfurt am Main, Hesse, 60590

  • Staedtisches Klinikum Karlsruhe /ID# 260348

    Karlsruhe, Baden-Wurttemberg, 76133

  • Klinikum Kassel /ID# 260432

    Kassel, Hesse, 34125

  • Klinikum Ludwigshafen /ID# 260688

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Otto-von-Guericke-Universitaet /ID# 260425

    Magdeburg, Saxony-Anhalt, 39120

Other trials in Germany

United Kingdom6 sites

  • Leeds Teaching Hospitals NHS Trust /ID# 260466

    Leeds, West Yorkshire, LS9 7TF

  • Hammersmith Hospital /ID# 261124

    London, England, W12 0HS

  • The Christie Hospital /ID# 260463

    Manchester, M20 4BX

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792

    Newcastle upon Tyne, NE3 3HD

  • University Hospitals Plymouth NHS Trust /ID# 262671

    Plymouth, Devon, PL6 8DH

  • Queen Alexandra Hospital /ID# 269708

    Portsmouth, Hampshire, PO6 3LY

Other trials in United Kingdom

Canada5 sites

  • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 260527

    Lévis, Quebec, G6V 3Z1

  • Victoria Hospital /ID# 260770

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l'Universite de Montreal /ID# 260617

    Montreal, Quebec, H2X 0C1

  • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 261075

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital - General Campus /ID# 264470

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Denmark5 sites

  • Rigshospitalet /ID# 260779

    Copenhagen Ø, Capital Region, 2100

  • Regionshospitalet Godstrup /ID# 260778

    Herning, Central Jutland, 7400

  • Odense University Hospital /ID# 260777

    Odense, Region Syddanmark, 5000

  • Roskilde Sygehus /ID# 260780

    Roskilde, Region Sjælland, 4000

  • Vejle Sygehus /ID# 260781

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Greece5 sites

  • General University Hospital of Alexandroupolis /ID# 260858

    Alexandroupoli, 68100

  • General Hospital of Athens Laiko /ID# 259708

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259709

    Athens, 10676

  • University General Hospital Attikon /ID# 260855

    Chaïdári, Attica, 12462

  • Olympion General Clinic /ID# 262395

    Pátrai, Achaia, 26443

Other trials in Greece

Hungary5 sites

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 260049

    Budapest, 1097

  • Orszagos Onkologiai Intezet /ID# 260052

    Budapest, 1122

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 260051

    Győr, Győr-Moson-Sopron, 9024

  • Tolna Varmegyei Balassa Janos Korhaz /ID# 260048

    Szekszárd, Tolna County, 7100

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 260050

    Szombathely, Vas County, 9700

Other trials in Hungary

Poland5 sites

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 260170

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Pratia MCM Krakow /ID# 260075

    Krakow, Lesser Poland Voivodeship, 30-727

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 260633

    Lodz, Łódź Voivodeship, 93-513

  • Aidport sp z o.o. /ID# 267717

    Poznan, Greater Poland Voivodeship, 60-175

  • Narodowy Instytut Onkologii im. M. Sklodowskiej /ID# 260861

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Serbia5 sites

  • Clinical Hospital Center Zvezdara /ID# 260900

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 259271

    Belgrade, Beograd, 11000

  • Institute for Oncology of Vojvodina /ID# 260223

    Kamenitz, Vojvodina, 21208

  • University Clinical Center Kragujevac /ID# 259274

    Kragujevac, Sumadijski Okrug, 34000

  • University Clinical Center Vojvodina /ID# 259272

    Novi Sad, 21000

Other trials in Serbia

Turkey (Türkiye)5 sites

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 259804

    Istanbul, 34899

  • Ege Universitesi Tip Fakultesi /ID# 259803

    Izmir, 35100

  • Kocaeli University Med Faculty /ID# 259717

    Kocaeli, 41380

  • Ondokuz Mayis Universitesi /ID# 259713

    Samsun, 55139

  • Istanbul Florence Nightingale Hospital /ID# 271291

    Şişli, Istanbul, 34381

Other trials in Turkey (Türkiye)

Bulgaria4 sites

  • UMHAT Dr Georgi Stranski EAD /ID# 260763

    Pleven, 5800

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685

    Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 259277

    Sofia, 1431

  • SHAT Hematologic Diseases /ID# 260457

    Sofia, 1797

Other trials in Bulgaria

Portugal4 sites

  • Fundacao Champalimaud /ID# 259652

    Lisbon, Lisbon District, 1400-038

  • Unidade Local de Saude de Santa Maria /ID# 259650

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 259649

    Porto, 4200-072

  • Unidade Local de Saude de Gaia/Espinho /ID# 259655

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Romania4 sites

  • Fundeni Clinical Institute /ID# 260296

    Bucharest, Bucharest, 022328

  • Spitalul Clinic Coltea /ID# 259699

    Bucharest, 030171

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 259704

    Cluj-Napoca, Cluj, 400015

  • Institutul Regional de Oncologie /ID# 259697

    Iași, Iaşi, 700483

Other trials in Romania

South Korea4 sites

  • Seoul National University Bundang Hospital /ID# 260009

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 260007

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 260010

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 260008

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Taiwan4 sites

  • China Medical University Hospital /ID# 260357

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 260361

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 260363

    Tainan, 704

  • National Taiwan University Hospital /ID# 260341

    Taipei, 100

Other trials in Taiwan

Czechia3 sites

  • Fakultni Nemocnice Brno - Jihlavska /ID# 260571

    Brno, Brno-mesto, 625 00

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 260560

    Hradec Králové, 500 05

  • Fakultni nemocnice Kralovske Vinohrady /ID# 260572

    Prague, 100 34

Other trials in Czechia

South Africa3 sites

  • Wits Clinical Research /ID# 260958

    Johannesburg, Gauteng, 1864

  • Haemalife Inc. /ID# 260513

    Kuils River, Western Cape, 7580

  • Alberts Cellular Therapy /ID# 260514

    Pretoria, Gauteng, 0044

Other trials in South Africa

New Zealand2 sites

  • Auckland City Hospital /ID# 259330

    Grafton, Auckland, 1023

  • North Shore Hospital /ID# 260824

    Takapuna, Auckland, 0622

Other trials in New Zealand

Puerto Rico2 sites

  • Pan American Center for Oncology Trials, LLC /ID# 260265

    Rio Piedras, 00935

  • Auxilio Mutuo Cancer Center /ID# 260262

    San Juan, 00918

Other trials in Puerto Rico

Slovakia2 sites

  • Narodny onkologicky ustav /ID# 260638

    Bratislava, Bratislava Region, 833 10

  • Univerzitna nemocnica Martin /ID# 260631

    Martin, Žilina Region, 036 01

Other trials in Slovakia

Sweden2 sites

  • Sodra Alvsborgs sjukhus /ID# 261168

    Borås, Västra Götaland County, 501 82

  • Sahlgrenska Universitetssjukhuset /ID# 266600

    Gothenburg, Västra Götaland County, 413 46

Other trials in Sweden

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

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 previously untreated 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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.

Read more

Participants will receive R2 (intravenous [IV] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) [G-CHOP]/ R-CHOP or G and IV infusion of bendamustine (Benda) [G-Benda]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment.

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.

Being tested
Epcoritamab, Prednisone, Rituximab, Lenalidomide, Doxorubicin
Keywords
Follicular Lymphoma (FL), Non-Hodgkin's lymphoma (NHL), Lymphoma, Cancer, Epcoritamab, Rituximab, Lenalidomide, Chemoimmunotherapy (CIT), Obinutuzumab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, Prednisone, Bendamustine (Benda), R-CHOP, G-CHOP, R-Benda, G-Benda, EPCORE™FL-2
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06191744
Study groupRoleWhat they receive
Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)ExperimentalParticipants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide
Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)ExperimentalParticipants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
Receives: Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide
Arm B: Chemoimmunotherapy (CIT) Option AExperimentalParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) [G-CHOP]/ rituximab (R)-CHOP during the 120 week treatment duration.
Receives: Drug: Prednisone; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Obinutuzumab
Arm B: Chemoimmunotherapy (CIT) Option BExperimentalParticipants will receive CIT Option B (G and bendamustine (Benda) [G-Benda]/R-Benda during the 120 week treatment duration.
Receives: Drug: Prednisone; Drug: Rituximab; Drug: Obinutuzumab; Drug: Bendamustine
Arm C: Lenalidomide and Rituximab (R2)ExperimentalParticipants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.
Receives: Drug: Rituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

    CR30 will be determined by positron emission tomography-computerized tomography (cat scan) [PET-CT] per Lugano 2014 criteria, as assessed by independent review committee (IRC).

    Measured: Up to 30 Months

  2. Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Measured: Up to 10 Years

Secondary outcomes (94)

  1. Arm A1 vs Arm B: Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death of any cause.

    Measured: Up to 10 Years

  2. Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate

    MRD negativity rate, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with follicular lymphoma (FL) MRD at baseline.

    Measured: Up to 10 Years

  3. Arm A1 vs Arm B: Change from Baseline in Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

    Measured: 21 Weeks

  4. Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 30 Months

  5. Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 30 Months

  6. Arm A1 vs Arm A2: Number of Participants with PFS

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Measured: Up to 10 Years

  7. Arm A1 vs Arm C: Number of Participants with PFS

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Measured: Up to 10 Years

  8. Arm A1 vs Arm A2: Rate of MRD Negativity

    MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.

    Measured: Up to 10 Years

  9. Arm A1 vs Arm C: Rate of MRD Negativity

    MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.

    Measured: Up to 10 Years

  10. Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

    Measured: Up to 10 Years

  11. Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

    Measured: Up to 10 Years

  12. Arm A1 vs Arm A2: OS

    OS is defined as the time from the date of randomization to the date of death of any cause.

    Measured: Up to 10 Years

  13. Arm A1 vs Arm C: OS

    OS is defined as the time from the date of randomization to the date of death of any cause.

    Measured: Up to 10 Years

  14. Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 30 Months

  15. Arm A1 vs Arm B: Percentage of Participants who Achieve CR30

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 30 Months

  16. Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 30 Months

  17. Arm A1 vs Arm A2: Number of Participants with PFS

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

    Measured: Up to 10 Years

  18. Arm A1 vs Arm B: Number of Participants with PFS

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

    Measured: Up to 10 Years

  19. Arm A1 vs Arm C: Number of Participants with PFS

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

    Measured: Up to 10 Years

  20. Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  21. Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  22. Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  23. Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  24. Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  25. Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  26. Arm A1 vs Arm A2: Number of Participants with Best Overall Response (BOR) per per Investigator

    BOR is defined as the percentage of participants who achieve CR or partial response (PR) determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 10 Years

  27. Arm A1 vs Arm A2: Number of Participants with BOR per IRC

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

    Measured: Up to 10 Years

  28. Arm A1 vs Arm B: Number of Participants with BOR per Investigator

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 10 Years

  29. Arm A1 vs Arm B: Number of Participants with BOR per IRC

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

    Measured: Up to 10 Years

  30. Arm A1 vs Arm C: Number of Participants with BOR per Investigator

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 10 Years

  31. Arm A1 vs Arm C: Number of Participants with BOR per IRC

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

    Measured: Up to 10 Years

  32. Arm A1 vs Arm A2: Number of Participants with Event-free Survival (EFS) per IRC

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Measured: Up to 10 Years

  33. Arm A1 vs Arm A2: Number of Participants with EFS per Investigator

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

    Measured: Up to 10 Years

  34. Arm A1 vs Arm B: Number of Participants with EFS per IRC

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Measured: Up to 10 Years

  35. Arm A1 vs Arm B: Number of Participants with EFS per Investigator

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

    Measured: Up to 10 Years

  36. Arm A1 vs Arm C: Number of Participants with EFS per IRC

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

    Measured: Up to 10 Years

  37. Arm A1 vs Arm C: Number of Participants with EFS per Investigator

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

    Measured: Up to 10 Years

  38. Arm A1 vs Arm A2: Duration of Response (DOR) per IRC

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  39. Arm A1 vs Arm A2: DOR per Investigator

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  40. Arm A1 vs Arm B: DOR per IRC

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  41. Arm A1 vs Arm B: DOR per Investigator

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  42. Arm A1 vs Arm C: DOR per IRC

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  43. Arm A1 vs Arm C: DOR per Investigator

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  44. Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRC

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  45. Arm A1 vs Arm A2: DOCR per Investigator

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  46. Arm A1 vs Arm B: DOCR per IRC

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  47. Arm A1 vs Arm B: DOCR per Investigator

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  48. Arm A1 vs Arm C: DOCR per IRC

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  49. Arm A1 vs Arm C: DOCR per Investigator

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  50. Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per Investigator

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  51. Arm A1 vs Arm A2: TTNT per IRC

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  52. Arm A1 vs Arm A2: TTNT per Investigator

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  53. Arm A1 vs Arm B: TTNT per IRC

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  54. Arm A1 vs Arm B: TTNT per Investigator

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  55. Arm A1 vs Arm C: TTNT per IRC

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  56. Arm A1 vs Arm C: TTNT per Investigator

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

    Measured: Up to 10 Years

  57. Arm A1 vs Arm A2: Time to Progression per IRC

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  58. Arm A1 vs Arm A2: Time to Progression per Investigator

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  59. Arm A1 vs Arm B: Time to Progression per IRC

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  60. Arm A1 vs Arm B: Time to Progression per Investigator

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  61. Arm A1 vs Arm C: Time to Progression per IRC

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.

    Measured: Up to 10 Years

  62. Arm A1 vs Arm C: Time to Progression per Investigator

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.

    Measured: Up to 10 Years

  63. Arm A1 vs Arm A2: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)

    PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 10 Years

  64. Arm A1 vs Arm B: Number of Participants with PFS2

    PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 10 Years

  65. Arm A1 vs Arm C: Number of Participants with PFS2

    PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 10 Years

  66. Arm A1 vs Arm A2: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

    Measured: Up to 10 Years

  67. Arm A1 vs Arm B: Change in Tolerability as Measured by PRO-CTCAE

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

    Measured: Up to 10 Years

  68. Arm A1 vs Arm C: Change in Tolerability as Measured by PRO-CTCAE

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

    Measured: Up to 10 Years

  69. Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5

    The functional assessment of cancer therapy singly item - GP5 (FACT-GP5) is a single question asking if participant is bothered by side effects of treatment.

    Measured: Up to 10 Years

  70. Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5

    The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.

    Measured: Up to 10 Years

  71. Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5

    The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.

    Measured: Up to 10 Years

  72. Arm A1 vs Arm A2: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  73. Arm A1 vs Arm B: Change in Symptoms as Measured by FACT-Lym

    The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  74. Arm A1 vs Arm C: Change in Symptoms as Measured by FACT-Lym

    The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  75. Arm A1 vs Arm A2: Change in Quality of Life (QoL) as Measured by FACT-Lym

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  76. Arm A1 vs Arm B: Change in QoL as Measured by FACT-Lym

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  77. Arm A1 vs Arm C: Change in QoL as Measured by FACT-Lym

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  78. Arm A1 vs Arm A2: Time-to-first PRO deterioration (TTD) in well-being using the lymphoma subscale (LymS) of FACT-Lym

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  79. Arm A1 vs Arm B: TTD in well-being using LymS of FACT-Lym

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  80. Arm A1 vs Arm C: TTD in well-being using LymS of FACT-Lym

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

    Measured: Up to 10 Years

  81. Arm A1 vs Arm A2: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

    Measured: Up to 10 Years

  82. Arm A1 vs Arm B: Change in QoL as Measured by EQ-5D-5L

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

    Measured: Up to 10 Years

  83. Arm A1 vs Arm C: Change in QoL as Measured by EQ-5D-5L

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

    Measured: Up to 10 Years

  84. Arm A1 vs Arm A2: TTD in PF using the QLQ-C30 Physical Functioning Scale

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

    Measured: Up to 10 Years

  85. Arm A1 vs Arm B: TTD in PF using the QLQ-C30 Physical Functioning Scale

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

    Measured: Up to 10 Years

  86. Arm A1 vs Arm C: TTD in PF using the QLQ-C30 Physical Functioning Scale

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

    Measured: Up to 10 Years

  87. Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    The EORTC QLQ-C30: A 30 items questionnaire to assess the quality of life of cancer patients on physical, emotional, cognitive, and social functions and symptoms. with a higher score indication worse quality of life.

    Measured: Up to 10 Years

  88. Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    The EORTC QLQ-C30: A 30 items questionnaire to assess the quality of life of cancer patients on physical, emotional, cognitive, and social functions and symptoms. with a higher score indication worse quality of life.

    Measured: Up to 10 Years

  89. Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    The EORTC QLQ-C30: A 30 items questionnaire to assess the quality of life of cancer patients on physical, emotional, cognitive, and social functions and symptoms. with a higher score indication worse quality of life.

    Measured: Up to 10 Years

  90. Arm A1 vs Arm A2: Change in Patient Global Impression of Change (PGIC) for General Lymphoma Symptoms

    The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

    Measured: Up to 10 Years

  91. Arm A1 vs Arm C: Change in PGIC for General Lymphoma Symptoms

    The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

    Measured: Up to 10 Years

  92. Arm A1 vs Arm A2: Change in Patient Global Impression of Severity (PGIS) for General Lymphoma Symptoms

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

    Measured: Up to 10 Years

  93. Arm A1 vs Arm B: Change in PGIS for General Lymphoma Symptoms

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

    Measured: Up to 10 Years

  94. Arm A1 vs Arm C: Change in PGIS for General Lymphoma Symptoms

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

    Measured: Up to 10 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start5 Feb 2024
  3. Primary completionNov 2037 (estimated)
  4. Study completionNov 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,095 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06191744
Sponsor's protocol ID
M22-003
Other IDs
2023-506906-38-00, 2023
Acronym
EPCORE™FL-2
Status last verified
Aug 2026
First submitted
20 Dec 2023
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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 (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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epcoritamab, Prednisone and Rituximab in people with Follicular Lymphoma (FL), run by Genmab at 266 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in United States, China, Japan, Spain, Australia and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30) (time frame: Up to 30 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06191744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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