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)

Status: Recruiting
Location: See all (246) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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.

Locations
United States
California
Scripps Mercy Hospital /ID# 265393
RECRUITING
San Diego
Sansum Clinic Research /ID# 261596
RECRUITING
Santa Barbara
Colorado
Rocky Mountain Cancer Centers - Boulder /ID# 261203
RECRUITING
Boulder
Delaware
Christiana Care Health Service /ID# 261207
RECRUITING
Newark
Florida
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
RECRUITING
Jacksonville
Advent Health /ID# 261578
RECRUITING
Orlando
Orlando Health Cancer Institute /ID# 260983
RECRUITING
Orlando
Iowa
University of Iowa Health Care /ID# 262132
RECRUITING
Des Moines
Idaho
Beacon Cancer Care /ID# 260670
RECRUITING
Coeur D'alene
Illinois
Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814
RECRUITING
Chicago
Cancer Care Specialists Of Central Illinois /ID# 272464
RECRUITING
Decatur
Illinois Cancer Care, PC /ID# 261526
RECRUITING
Peoria
Indiana
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583
RECRUITING
Fort Wayne
Kentucky
Norton Cancer Institute - St. Matthews /ID# 261076
RECRUITING
Louisville
University of Louisville Hospital /ID# 260544
RECRUITING
Louisville
Maryland
University of Maryland, Baltimore /ID# 259538
RECRUITING
Baltimore
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476
RECRUITING
Bethesda
Maine
New England Cancer Specialists - Westbrook /ID# 260672
RECRUITING
Westbrook
Missouri
St. Luke's Hospital - Chesterfield /ID# 260489
RECRUITING
Chesterfield
Montana
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006
RECRUITING
Billings
North Carolina
Novant Health Presbyterian Medical Center /ID# 259740
RECRUITING
Charlotte
Novant Health Forsyth Medical Center /ID# 259741
RECRUITING
Winston-salem
Nebraska
Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506
RECRUITING
Grand Island
NHO - Nebraska Hematology-Oncology /ID# 269692
RECRUITING
Lincoln
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505
RECRUITING
Omaha
University of Nebraska Medical Center /ID# 261996
RECRUITING
Omaha
New Mexico
Presbyterian Kaseman Hospital /ID# 262451
RECRUITING
Albuquerque
University of New Mexico /ID# 261083
RECRUITING
Albuquerque
Presbyterian Rust Medical Center /ID# 262447
RECRUITING
Rio Rancho
New York
New York Oncology Hematology - Albany Cancer Center /ID# 261814
RECRUITING
Albany
NYU Langone Hospital - Long Island /ID# 265531
RECRUITING
Mineola
Icahn School of Medicine at Mount Sinai /ID# 259595
RECRUITING
New York
NYU Langone Medical Center /ID# 264518
RECRUITING
New York
New York Oncology Hematology /ID# 270208
RECRUITING
Troy
Clinical Research Alliance, Inc. /ID# 261078
RECRUITING
Westbury
Ohio
Oncology Hematology Care, Inc - Blue Ash /ID# 261204
RECRUITING
Cincinnati
Taylor Cancer Research Center /ID# 260488
COMPLETED
Maumee
Oregon
Oncology Associates of Oregon, P.C. /ID# 261816
RECRUITING
Eugene
South Carolina
MUSC Hollings Cancer Center /ID# 259604
RECRUITING
Charleston
Prisma Health /ID# 259602
RECRUITING
Greenville
Texas
Texas Oncology - Austin Midtown /ID# 261208
RECRUITING
Austin
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206
RECRUITING
Dallas
MD Anderson Cancer Center /ID# 260984
RECRUITING
Houston
Oncology Consultants /ID# 268390
RECRUITING
Houston
Joe Arrington Cancer Research /ID# 260382
RECRUITING
Lubbock
Utah
Intermountain Healthcare LDS Hospital /ID# 259759
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists - Fairfax /ID# 261205
RECRUITING
Fairfax
Oncology and Hematology Associates of Southwest Virginia /ID# 261592
RECRUITING
Roanoke
Washington
Swedish Cancer Institute - Edmonds /ID# 266356
RECRUITING
Edmonds
Swedish Cancer Institute - Issaquah /ID# 266358
RECRUITING
Issaquah
Vista Oncology - East Olympia /ID# 261360
RECRUITING
Olympia
Swedish Cancer Institute /ID# 260370
RECRUITING
Seattle
Virginia Mason Hospital & Medical Center /ID# 260549
RECRUITING
Seattle
Northwest Medical Specialties - Tacoma /ID# 262133
RECRUITING
Tacoma
Other Locations
Australia
Royal Prince Alfred Hospital /ID# 259320
RECRUITING
Camperdown
Townsville University Hospital /ID# 259323
RECRUITING
Douglas
Peninsula Private Hospital /ID# 259325
RECRUITING
Frankston
Royal Brisbane and Women's Hospital /ID# 259326
RECRUITING
Herston
Liverpool Hospital /ID# 259321
RECRUITING
Liverpool
Peter MacCallum Cancer Center /ID# 260431
RECRUITING
Melbourne
Fiona Stanley Hospital /ID# 259324
RECRUITING
Murdoch
Royal Perth Hospital /ID# 259319
RECRUITING
Perth
Westmead Hospital /ID# 261465
RECRUITING
Westmead
Princess Alexandra Hospital /ID# 259329
RECRUITING
Woolloongabba
Belgium
Algemeen Ziekenhuis klina /ID# 260324
RECRUITING
Brasschaat
Cliniques Universitaires UCL Saint-Luc /ID# 260311
RECRUITING
Brussels
Uza /Id# 260319
RECRUITING
Edegem
UZ Gent /ID# 260312
RECRUITING
Ghent
Universitair Ziekenhuis Leuven /ID# 260304
RECRUITING
Leuven
Groupe Sante CHC - Clinique du MontLegia /ID# 260325
RECRUITING
Liège
AZ-Delta /ID# 260313
RECRUITING
Roeselare
Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 260763
RECRUITING
Pleven
Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685
RECRUITING
Sofia
SHAT Hematologic Diseases /ID# 260457
RECRUITING
Sofia
UMHAT Sveti Ivan Rilski /ID# 259277
RECRUITING
Sofia
Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 260527
RECRUITING
Lévis
Victoria Hospital /ID# 260770
RECRUITING
London
Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 260617
RECRUITING
Montreal
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 261075
RECRUITING
Montreal
The Ottawa Hospital - General Campus /ID# 264470
RECRUITING
Ottawa
China
Peking University First Hospital /ID# 259816
RECRUITING
Beijing
Peking University Third Hospital /ID# 259806
RECRUITING
Beijing
Hunan Cancer Hospital /ID# 260439
RECRUITING
Changsha
West China Hospital, Sichuan University /ID# 260015
RECRUITING
Chengdu
Guangdong Provincial Peoples Hospital /ID# 260446
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University /ID# 260795
RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Center /ID# 260478
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University /ID# 260558
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 259744
RECRUITING
Hangzhou
Zhejiang Cancer hospital /ID# 259742
RECRUITING
Hangzhou
Shandong Cancer Hospital /ID# 260808
RECRUITING
Jinan
Yunnan Cancer Hospital /ID# 260645
RECRUITING
Kunming
Jiangxi Provincial Cancer Hospital /ID# 260559
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University /ID# 260556
RECRUITING
Nanchang
Affiliated Cancer Hospital of Guangxi Medical University /ID# 260537
RECRUITING
Nanning
Fudan University Cancer Hospital /ID# 260564
RECRUITING
Shanghai
The First Hospital of China Medical University /ID# 260217
RECRUITING
Shenyang
Shenzhen People's Hospital /ID# 260137
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University /ID# 260507
RECRUITING
Suzhou
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259616
RECRUITING
Tianjin
Tianjin Cancer Hospital /ID# 259807
RECRUITING
Tianjin
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 260644
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University /ID# 260566
RECRUITING
Wenzhou
Hubei Cancer Hospital /ID# 260506
RECRUITING
Wuhan
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 259743
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University /ID# 260014
RECRUITING
Xiamen
Henan Cancer Hospital /ID# 259618
RECRUITING
Zhengzhou
People's Hospital of Henan Province /ID# 259619
RECRUITING
Zhengzhou
Croatia
Klinicki bolnicki centar Rijeka /ID# 260455
RECRUITING
Rijeka
Klinicki Bolnicki Centar (KBC) Split /ID# 260454
RECRUITING
Split
Zadar General Hospital /ID# 260837
RECRUITING
Zadar
Clinical Hospital Dubrava /ID# 260452
RECRUITING
Zagreb
Klinicka bolnica Merkur /ID# 260393
RECRUITING
Zagreb
Klinicki bolnicki centar Sestre milosrdnice /ID# 260456
RECRUITING
Zagreb
Klinicki bolnicki centar Zagreb /ID# 260364
RECRUITING
Zagreb
Denmark
Rigshospitalet /ID# 260779
RECRUITING
Copenhagen Ø
Regionshospitalet Godstrup /ID# 260778
RECRUITING
Herning
Odense University Hospital /ID# 260777
RECRUITING
Odense
Roskilde Sygehus /ID# 260780
RECRUITING
Roskilde
Vejle Sygehus /ID# 260781
RECRUITING
Vejle
France
Hopital Prive d'Antony /ID# 260598
RECRUITING
Antony
Centre Hospitalier D'Avignon /ID# 260511
RECRUITING
Avignon
CHU Brest - Hôpital de la Cavale Blanche /ID# 260601
RECRUITING
Brest
CHU de CAEN - Hopital de la Cote de Nacre /ID# 260875
RECRUITING
Caen
Centre Hospitalier du Mans /ID# 260510
RECRUITING
Le Mans
CH Libourne - Hopital Robert Boulin /ID# 261478
RECRUITING
Libourne
Hopital Prive du Confluent /ID# 260596
RECRUITING
Nantes
Hôpital Saint-Louis /ID# 260509
RECRUITING
Paris
HCL - Hopital Lyon Sud /ID# 260508
RECRUITING
Pierre-bénite
Clinique Sainte-Anne /ID# 261528
RECRUITING
Strasbourg
Germany
St.-Antonius-Hospital /ID# 260520
RECRUITING
Eschweiler
Universitaetsklinikum Frankfurt /ID# 260388
RECRUITING
Frankfurt Am Main
Staedtisches Klinikum Karlsruhe /ID# 260348
RECRUITING
Karlsruhe
Klinikum Kassel /ID# 260432
RECRUITING
Kassel
Klinikum Ludwigshafen /ID# 260688
RECRUITING
Ludwigshafen Am Rhein
Otto-von-Guericke-Universitaet /ID# 260425
RECRUITING
Magdeburg
Greece
General University Hospital of Alexandroupolis /ID# 260858
RECRUITING
Alexandroupoli
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259709
RECRUITING
Athens
General Hospital of Athens Laiko /ID# 259708
RECRUITING
Athens
University General Hospital Attikon /ID# 260855
RECRUITING
Athens
Olympion General Clinic /ID# 262395
RECRUITING
Pátrai
Hungary
Orszagos Onkologiai Intezet /ID# 260052
RECRUITING
Budapest
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 260051
RECRUITING
Győr
Tolna Varmegyei Balassa Janos Korhaz /ID# 260048
RECRUITING
Szekszárd
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 260050
RECRUITING
Szombathely
Israel
HaEmek Medical Center /ID# 259936
RECRUITING
Afula
Soroka University Medical Center /ID# 259937
RECRUITING
Beersheba
Hadassah /ID# 259935
RECRUITING
Jerusalem
Meir Medical Center /ID# 259938
RECRUITING
Kfar Saba
Rabin Medical Center /ID# 268328
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 259934
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 259933
RECRUITING
Tel Aviv
Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 260886
RECRUITING
Bologna
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 260889
RECRUITING
Candiolo
AOU Policlinico G. Rodolico - San Marco /ID# 260890
RECRUITING
Catania
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 260888
RECRUITING
Palermo
AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 260744
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 260891
RECRUITING
Roma
IRCCS Istituto Clinico Humanitas /ID# 260887
RECRUITING
Rozzano
Japan
Aomori Prefectural Central Hospital /ID# 265692
RECRUITING
Aomori
Tokyo Metropolitan Komagome Hospital /ID# 267692
RECRUITING
Bunkyo Ku
The University of Tokyo Hospital /ID# 266422
RECRUITING
Bunkyo-ku
Chiba Cancer Center /ID# 267316
COMPLETED
Chiba
University of Yamanashi Hospital /ID# 264677
RECRUITING
Chuo-shi
Kyushu University Hospital /ID# 267861
RECRUITING
Fukuoka
National Hospital Organization Kyushu Cancer Center /ID# 265960
RECRUITING
Fukuoka
Fukushima Medical University Hospital /ID# 264994
RECRUITING
Fukushima
Chugoku Central Hospital /ID# 266520
RECRUITING
Fukuyama
Kansai Medical University Hirakata Hospital /ID# 266019
RECRUITING
Hirakata-shi
Hitachi General Hospital /ID# 265676
RECRUITING
Hitachi-shi
Kobe City Medical Center General Hospital /ID# 266379
RECRUITING
Kobe
Matsuyama Red Cross Hospital /ID# 266426
RECRUITING
Matsuyama
Okayama University Hospital /ID# 267135
RECRUITING
Okayama
Kindai University Hospital /ID# 265038
RECRUITING
Osaka Sayama-shi
Kitasato University Hospital /ID# 264675
RECRUITING
Sagamihara-shi
Sapporo Medical University Hospital /ID# 265031
RECRUITING
Sapporo
Fujita Health University Hospital /ID# 264679
RECRUITING
Toyoake
Yamaguchi University Hospital /ID# 265619
RECRUITING
Ube
Kanagawa Cancer Center /ID# 265497
RECRUITING
Yokohama
University of Fukui Hospital /ID# 265680
RECRUITING
Yoshida-gun
Netherlands
Olvg /Id# 259543
RECRUITING
Amsterdam
Rijnstate /ID# 261219
RECRUITING
Arnhem
Bravis Ziekenhuis /ID# 259055
RECRUITING
Bergen Op Zoom
Universitair Medisch Centrum Groningen /ID# 259051
RECRUITING
Groningen
Leids Universitair Medisch Centrum /ID# 259049
RECRUITING
Leiden
St. Antonius Ziekenhuis /ID# 259053
RECRUITING
Nieuwegein
Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 259052
RECRUITING
Rotterdam
HagaZiekenhuis /ID# 261220
RECRUITING
The Hague
Elisabeth Tweesteden Ziekenhuis /ID# 261239
RECRUITING
Tilburg
New Zealand
Auckland City Hospital /ID# 259330
RECRUITING
Grafton
North Shore Hospital /ID# 260824
RECRUITING
Takapuna
Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 260170
RECRUITING
Kielce
Pratia MCM Krakow /ID# 260075
RECRUITING
Krakow
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 260633
RECRUITING
Lodz
Aidport sp z o.o. /ID# 267717
RECRUITING
Poznan
Narodowy Instytut Onkologii im. M. Sklodowskiej /ID# 260861
RECRUITING
Warsaw
Portugal
Fundacao Champalimaud /ID# 259652
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE /ID# 259650
RECRUITING
Lisbon
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 259649
RECRUITING
Porto
Unidade Local de Saude de Gaia/Espinho, EPE /ID# 259655
RECRUITING
Vila Nova De Gaia
Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 260265
RECRUITING
Rio Piedras
Auxilio Mutuo Cancer Center /ID# 260262
RECRUITING
San Juan
Republic of Korea
Seoul National University Bundang Hospital /ID# 260009
RECRUITING
Seongnam-si
Asan Medical Center /ID# 260010
RECRUITING
Seoul
Samsung Medical Center /ID# 260008
RECRUITING
Seoul
Seoul National University Hospital /ID# 260007
RECRUITING
Seoul
Romania
Fundeni Clinical Institute /ID# 260296
RECRUITING
Bucharest
Spitalul Clinic Coltea /ID# 259699
RECRUITING
Bucharest
Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 259704
RECRUITING
Cluj-napoca
Institutul Regional de Oncologie /ID# 259697
RECRUITING
Iași
Serbia
Clinical Hospital Center Zvezdara /ID# 260900
RECRUITING
Belgrade
University Clinical Center Serbia /ID# 259271
RECRUITING
Belgrade
Institute for Oncology of Vojvodina /ID# 260223
RECRUITING
Kamenitz
University Clinical Center Kragujevac /ID# 259274
RECRUITING
Kragujevac
University Clinical Center Vojvodina /ID# 259272
RECRUITING
Novi Sad
Slovakia
Narodny onkologicky ustav /ID# 260638
RECRUITING
Bratislava
Univerzitna nemocnica Martin /ID# 260631
RECRUITING
Martin
South Africa
Haemalife Inc. /ID# 260513
RECRUITING
Kuils River
Alberts Cellular Therapy /ID# 260514
RECRUITING
Pretoria
Spain
Instituto Catalan de Oncologia (ICO) Badalona /ID# 260495
RECRUITING
Badalona
Hospital Clinic de Barcelona /ID# 260492
RECRUITING
Barcelona
Hospital Santa Creu i Sant Pau /ID# 260498
RECRUITING
Barcelona
Hospital Universitario Vall de Hebron /ID# 260490
RECRUITING
Barcelona
Hospital San Pedro de Alcantara /ID# 260502
RECRUITING
Cáceres
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 261439
RECRUITING
L'hospitalet De Llobregat
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 261512
RECRUITING
Madrid
MD Anderson Madrid /ID# 260500
RECRUITING
Madrid
Clinica Universidad de Navarra - Pamplona /ID# 260496
RECRUITING
Pamplona
Hospital Universitario de Salamanca /ID# 260491
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla /ID# 260497
RECRUITING
Santander
Sweden
Sodra Alvsborgs sjukhus /ID# 261168
RECRUITING
Borås
Taiwan
China Medical University Hospital /ID# 260357
RECRUITING
Taichung
Taichung Veterans General Hospital /ID# 260361
RECRUITING
Taichung
National Cheng Kung University Hospital /ID# 260363
RECRUITING
Tainan City
National Taiwan University Hospital /ID# 260341
RECRUITING
Taipei City
Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 259804
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi /ID# 259803
RECRUITING
Izmir
Kocaeli University Med Faculty /ID# 259717
RECRUITING
Kocaeli
Ondokuz Mayis Universitesi /ID# 259713
RECRUITING
Samsun
Istanbul Florence Nightingale Hospital /ID# 271291
RECRUITING
Şişli
United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 260466
RECRUITING
Leeds
Hammersmith Hospital /ID# 261124
RECRUITING
London
The Christie Hospital /ID# 260463
RECRUITING
Manchester
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792
RECRUITING
Newcastle Upon Tyne
Derriford Hospital and the Royal Eye Infirmary /ID# 262671
RECRUITING
Plymouth
Queen Alexandra Hospital /ID# 269708
RECRUITING
Portsmouth
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2037-11
Participants
Target number of participants: 1095
Treatments
Experimental: Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)
Participants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
Experimental: Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)
Participants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
Experimental: Arm B: Chemoimmunotherapy (CIT) Option A
Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Experimental: Arm B: Chemoimmunotherapy (CIT) Option B
Participants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.
Experimental: Arm C: Lenalidomide and Rituximab (R2)
Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.
Sponsors
Collaborators: AbbVie
Leads: Genmab

This content was sourced from clinicaltrials.gov