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 (EPCORE™FL-2)

May 4, 2026 updated by: Genmab

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.

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.

Study Overview

Status

Recruiting

Conditions

Follicular Lymphoma (FL)

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1095

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Recruiting
    - Royal Prince Alfred Hospital /ID# 259320
  - Liverpool, New South Wales, Australia, 2170
    - Recruiting
    - Liverpool Hospital /ID# 259321
  - Melbourne, New South Wales, Australia, 3000
    - Recruiting
    - Peter MacCallum Cancer Center /ID# 260431
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Westmead Hospital /ID# 261465
- Queensland
  - Douglas, Queensland, Australia, 4814
    - Recruiting
    - Townsville University Hospital /ID# 259323
  - Herston, Queensland, Australia, 4029
    - Recruiting
    - Royal Brisbane and Women's Hospital /ID# 259326
  - Woolloongabba, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital /ID# 259329
- Victoria
  - Frankston, Victoria, Australia, 3199
    - Recruiting
    - Peninsula Private Hospital /ID# 259325
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Recruiting
    - Fiona Stanley Hospital /ID# 259324
  - Perth, Western Australia, Australia, 6000
    - Recruiting
    - Royal Perth Hospital /ID# 259319
Belgium
- Antwerpen
  - Brasschaat, Antwerpen, Belgium, 2930
    - Recruiting
    - Algemeen Ziekenhuis klina /ID# 260324
  - Edegem, Antwerpen, Belgium, 2650
    - Recruiting
    - Uza /Id# 260319
- Brussels Capital
  - Brussels, Brussels Capital, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires UCL Saint-Luc /ID# 260311
- Liege
  - Liège, Liege, Belgium, 4000
    - Completed
    - Groupe Sante CHC - Clinique du MontLegia /ID# 260325
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent /ID# 260312
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Recruiting
    - Universitair Ziekenhuis Leuven /ID# 260304
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - Recruiting
    - AZ-Delta. /ID# 260313
Brazil
- - Rio de Janeiro, Brazil, 22250-905
    - Recruiting
    - Grupo Oncoclínicas Botafogo /ID# 260870
  - São Paulo, Brazil, 01401-002
    - Recruiting
    - Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 260829
  - São Paulo, Brazil, 05403-000
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 260822
  - São Paulo, Brazil, 01323-001
    - Recruiting
    - Real e Benemérita Associação Portuguesa de Beneficência /ID# 260826
- Federal District
  - Brasília, Federal District, Brazil, 70390-140
    - Recruiting
    - DF Star /ID# 260844
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30360-680
    - Recruiting
    - Oncocentro de Minas Gerais /ID# 260973
- Puerto Rico
  - Curitiba, Puerto Rico, Brazil, 81520-060
    - Recruiting
    - Hospital Erasto Gaertner /ID# 260871
- São Paulo
  - Jaú, São Paulo, Brazil, 17210-070
    - Recruiting
    - Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 260828
  - Ribeirão Preto, São Paulo, Brazil, 14049-900
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 260843
  - São Paulo, São Paulo, Brazil, 01509-900
    - Recruiting
    - Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 260827
Bulgaria
- - Pleven, Bulgaria, 5800
    - Completed
    - UMHAT Dr Georgi Stranski EAD /ID# 260763
  - Sofia, Bulgaria, 1797
    - Recruiting
    - SHAT Hematologic Diseases /ID# 260457
  - Sofia, Bulgaria, 1407
    - Completed
    - Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685
  - Sofia, Bulgaria, 1431
    - Completed
    - UMHAT Sveti Ivan Rilski /ID# 259277
Canada
- Ontario
  - London, Ontario, Canada, N6A 4L6
    - Recruiting
    - Victoria Hospital /ID# 260770
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - The Ottawa Hospital - General Campus /ID# 264470
- Quebec
  - Lévis, Quebec, Canada, G6V 3Z1
    - Recruiting
    - CSSS Alphonse-Desjardins, CHAU de Levis /ID# 260527
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 261075
  - Montreal, Quebec, Canada, H2X 0C1
    - Recruiting
    - Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 260617
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100034
    - Recruiting
    - Peking University First Hospital /ID# 259816
  - Beijing, Beijing Municipality, China, 100191
    - Recruiting
    - Peking University Third Hospital /ID# 259806
- Fujian
  - Xiamen, Fujian, China, 361003
    - Recruiting
    - The First Affiliated Hospital of Xiamen University /ID# 260014
- Guangdong
  - Guangzhou, Guangdong, China, 510280
    - Recruiting
    - Zhujiang Hospital of Southern Medical University /ID# 260558
  - Guangzhou, Guangdong, China, 510060
    - Recruiting
    - Sun Yat-Sen University Cancer Center /ID# 260478
  - Guangzhou, Guangdong, China, 510515
    - Recruiting
    - Nanfang Hospital of Southern Medical University /ID# 260795
  - Guangzhou, Guangdong, China, 510080
    - Recruiting
    - Guangdong Provincial Peoples Hospital /ID# 260446
  - Shenzhen, Guangdong, China, 518020
    - Recruiting
    - Shenzhen People's Hospital /ID# 260137
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Recruiting
    - Affiliated Cancer Hospital of Guangxi Medical University /ID# 260537
- Henan
  - Zhengzhou, Henan, China, 450003
    - Recruiting
    - People's Hospital of Henan Province /ID# 259619
  - Zhengzhou, Henan, China, 450008
    - Recruiting
    - Henan Cancer Hospital /ID# 259618
- Hubei
  - Wuhan, Hubei, China, 430079
    - Recruiting
    - Hubei Cancer Hospital /ID# 260506
  - Wuhan, Hubei, China, 430048
    - Recruiting
    - Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 259743
- Hunan
  - Changsha, Hunan, China, 410006
    - Recruiting
    - Hunan Cancer Hospital /ID# 260439
- Jiangsu
  - Suzhou, Jiangsu, China, 215006
    - Recruiting
    - The First Affiliated Hospital of Soochow University /ID# 260507
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - The First Affiliated Hospital of Nanchang University /ID# 260556
  - Nanchang, Jiangxi, China, 330029
    - Recruiting
    - Jiangxi Provincial Cancer Hospital /ID# 260559
- Liaoning
  - Shenyang, Liaoning, China, 110001
    - Recruiting
    - First Affiliated Hospital of China Medical University /ID# 260217
- Shandong
  - Jinan, Shandong, China, 251601
    - Recruiting
    - Shandong Cancer Hospital /ID# 260808
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Recruiting
    - Fudan University Cancer Hospital /ID# 260564
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - West China Hospital, Sichuan University /ID# 260015
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300000
    - Recruiting
    - Tianjin Cancer Hospital /ID# 259807
  - Tianjin, Tianjin Municipality, China, 300020
    - Recruiting
    - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259616
- Xinjiang
  - Ürümqi, Xinjiang, China, 830000
    - Recruiting
    - The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 260644
- Yunnan
  - Kunming, Yunnan, China, 650118
    - Recruiting
    - Yunnan Cancer Hospital /ID# 260645
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Recruiting
    - Zhejiang Cancer hospital /ID# 259742
  - Hangzhou, Zhejiang, China, 310003
    - Recruiting
    - The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 259744
  - Wenzhou, Zhejiang, China, 325000
    - Recruiting
    - The First Affiliated Hospital of Wenzhou Medical University /ID# 260566
Croatia
- - Zadar, Croatia, 23000
    - Recruiting
    - Zadar General Hospital /ID# 260837
- City of Zagreb
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Dubrava /ID# 260452
  - Zagreb, City of Zagreb, Croatia, 10000
    - Recruiting
    - Klinicki bolnicki centar Zagreb /ID# 260364
  - Zagreb, City of Zagreb, Croatia, 10000
    - Completed
    - Klinicka bolnica Merkur /ID# 260393
  - Zagreb, City of Zagreb, Croatia, 10000
    - Completed
    - Klinicki bolnicki centar Sestre milosrdnice /ID# 260456
- Primorje-Gorski Kotar County
  - Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
    - Recruiting
    - Klinicki bolnicki centar Rijeka /ID# 260455
- Split-Dalmatia County
  - Split, Split-Dalmatia County, Croatia, 21000
    - Recruiting
    - Klinicki Bolnicki Centar (KBC) Split /ID# 260454
Czechia
- - Prague, Czechia, 100 34
    - Recruiting
    - Fakultni nemocnice Kralovske Vinohrady /ID# 260572
- Brno-mesto
  - Brno, Brno-mesto, Czechia, 625 00
    - Recruiting
    - Fakultni Nemocnice Brno - Jihlavska /ID# 260571
- Hradec Kralove
  - Hradec Králové, Hradec Kralove, Czechia, 500 05
    - Recruiting
    - Fakultní nemocnice Hradec Králové - Sokolská /ID# 260560
Denmark
- Capital Region
  - Copenhagen Ø, Capital Region, Denmark, 2100
    - Recruiting
    - Rigshospitalet /ID# 260779
    - Contact:
      
      Site Coordinator
- Central Jutland
  - Herning, Central Jutland, Denmark, 7400
    - Completed
    - Regionshospitalet Godstrup /ID# 260778
- Region Sjælland
  - Roskilde, Region Sjælland, Denmark, 4000
    - Recruiting
    - Roskilde Sygehus /ID# 260780
- Region Syddanmark
  - Odense, Region Syddanmark, Denmark, 5000
    - Recruiting
    - Odense University Hospital /ID# 260777
  - Vejle, Region Syddanmark, Denmark, 7100
    - Recruiting
    - Vejle Sygehus /ID# 260781
France
- - Libourne, France, 33500
    - Recruiting
    - CH Libourne - Hopital Robert Boulin /ID# 261478
  - Paris, France, 75010
    - Recruiting
    - Hopital Saint-Louis /ID# 260509
  - Strasbourg, France, 67085
    - Recruiting
    - Clinique Sainte-Anne /ID# 261528
- Calvados
  - Caen, Calvados, France, 14033
    - Recruiting
    - CHU de CAEN - Hopital de la Cote de Nacre /ID# 260875
- Finistere
  - Brest, Finistere, France, 29200
    - Recruiting
    - CHU Brest - Hôpital de la Cavale Blanche /ID# 260601
- Loire-Atlantique
  - Nantes, Loire-Atlantique, France, 44277
    - Recruiting
    - Hopital Prive du Confluent /ID# 260596
- Provence-Alpes-Côte d'Azur Region
  - Avignon, Provence-Alpes-Côte d'Azur Region, France, 84000
    - Recruiting
    - Centre Hospitalier D'Avignon /ID# 260511
- Rhone
  - Pierre-Bénite, Rhone, France, 69495
    - Recruiting
    - HCL - Hopital Lyon Sud /ID# 260508
- Sarthe
  - Le Mans, Sarthe, France, 72037
    - Recruiting
    - Centre Hospitalier du Mans /ID# 260510
- Île-de-France Region
  - Antony, Île-de-France Region, France, 92160
    - Recruiting
    - Hopital Prive d'Antony /ID# 260598
Germany
- Baden-Wurttemberg
  - Karlsruhe, Baden-Wurttemberg, Germany, 76133
    - Recruiting
    - Staedtisches Klinikum Karlsruhe /ID# 260348
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60590
    - Recruiting
    - Universitaetsklinikum Frankfurt /ID# 260388
  - Kassel, Hesse, Germany, 34125
    - Recruiting
    - Klinikum Kassel /ID# 260432
- North Rhine-Westphalia
  - Eschweiler, North Rhine-Westphalia, Germany, 52249
    - Completed
    - St.-Antonius-Hospital /ID# 260520
- Rhineland-Palatinate
  - Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
    - Recruiting
    - Klinikum Ludwigshafen /ID# 260688
- Saxony-Anhalt
  - Magdeburg, Saxony-Anhalt, Germany, 39120
    - Recruiting
    - Otto-von-Guericke-Universitaet /ID# 260425
Greece
- - Alexandroupoli, Greece, 68100
    - Recruiting
    - General University Hospital of Alexandroupolis /ID# 260858
  - Athens, Greece, 10676
    - Recruiting
    - General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259709
- Achaia
  - Pátrai, Achaia, Greece, 26443
    - Recruiting
    - Olympion General Clinic /ID# 262395
- Attica
  - Athens, Attica, Greece, 11527
    - Recruiting
    - General Hospital of Athens Laiko /ID# 259708
  - Athens, Attica, Greece, 12462
    - Recruiting
    - University General Hospital Attikon /ID# 260855
Hungary
- - Budapest, Hungary, 1122
    - Recruiting
    - Orszagos Onkologiai Intezet /ID# 260052
  - Budapest, Hungary, 1097
    - Completed
    - Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 260049
- Győr-Moson-Sopron
  - Győr, Győr-Moson-Sopron, Hungary, 9024
    - Completed
    - Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 260051
- Tolna County
  - Szekszárd, Tolna County, Hungary, 7100
    - Recruiting
    - Tolna Varmegyei Balassa Janos Korhaz /ID# 260048
- Vas County
  - Szombathely, Vas County, Hungary, 9700
    - Recruiting
    - Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 260050
Israel
- Central District
  - Kfar Saba, Central District, Israel, 4428164
    - Recruiting
    - Meir Medical Center /ID# 259938
  - Petah Tikva, Central District, Israel, 4941492
    - Recruiting
    - Rabin Medical Center. /ID# 268328
- Haifa District
  - Afula, Haifa District, Israel, 1834111
    - Recruiting
    - HaEmek Medical Center /ID# 259936
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 91120
    - Recruiting
    - Hadassah /ID# 259935
- Southern District
  - Beersheba, Southern District, Israel, 8443901
    - Recruiting
    - Soroka University Medical Center /ID# 259937
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 5265601
    - Recruiting
    - The Chaim Sheba Medical Center /ID# 259934
  - Tel Aviv, Tel Aviv, Israel, 6423906
    - Recruiting
    - Tel Aviv Sourasky Medical Center /ID# 259933
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 260886
  - Catania, Italy, 95123
    - Recruiting
    - AOU Policlinico G. Rodolico - San Marco /ID# 260890
  - Palermo, Italy, 90146
    - Recruiting
    - Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 260888
  - Reggio Emilia, Italy, 42122
    - Recruiting
    - AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 260744
  - Roma, Italy, 00128
    - Recruiting
    - Fondazione Policlinico Universitario Campus Bio-Medico /ID# 260891
- Lombardy
  - Rozzano, Lombardy, Italy, 20089
    - Recruiting
    - IRCCS Istituto Clinico Humanitas /ID# 260887
- Torino
  - Candiolo, Torino, Italy, 10060
    - Recruiting
    - Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 260889
Japan
- - Aomori, Japan, 030-0913
    - Recruiting
    - Aomori Prefectural Central Hospital /ID# 265692
  - Chiba, Japan, 260-0801
    - Completed
    - Chiba Cancer Center /ID# 267316
- Aichi-ken
  - Toyoake, Aichi-ken, Japan, 470-1192
    - Recruiting
    - Fujita Health University Hospital /ID# 264679
- Ehime
  - Matsuyama, Ehime, Japan, 790-8524
    - Recruiting
    - Matsuyama Red Cross Hospital /ID# 266426
- Fukui
  - Yoshida-gun, Fukui, Japan, 910-1104
    - Recruiting
    - University of Fukui Hospital /ID# 265680
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center /ID# 265960
  - Fukuoka, Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital /ID# 267861
- Fukushima
  - Fukushima, Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital /ID# 264994
- Hiroshima
  - Fukuyama, Hiroshima, Japan, 720-0001
    - Recruiting
    - Chugoku Central Hospital /ID# 266520
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8543
    - Recruiting
    - Sapporo Medical University Hospital /ID# 265031
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0047
    - Completed
    - Kobe City Medical Center General Hospital /ID# 266379
- Ibaraki
  - Hitachi-shi, Ibaraki, Japan, 317-0077
    - Recruiting
    - Hitachi General Hospital /ID# 265676
- Kanagawa
  - Sagamihara-shi, Kanagawa, Japan, 252-0375
    - Recruiting
    - Kitasato University Hospital /ID# 264675
  - Yokohama, Kanagawa, Japan, 241-8515
    - Recruiting
    - Kanagawa Cancer Center /ID# 265497
- Okayama-ken
  - Okayama, Okayama-ken, Japan, 700-8558
    - Completed
    - Okayama University Hospital /ID# 267135
- Osaka
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital /ID# 266019
  - Sakai-shi, Osaka, Japan, 590-0197
    - Recruiting
    - Kindai University Hospital /ID# 265038
- Tokyo
  - Bunkyo Ku, Tokyo, Japan, 113-8677
    - Recruiting
    - Tokyo Metropolitan Komagome Hospital /ID# 267692
  - Bunkyo-ku, Tokyo, Japan, 113-8654
    - Recruiting
    - The University of Tokyo Hospital /ID# 266422
- Yamaguchi
  - Ube, Yamaguchi, Japan, 755-8505
    - Recruiting
    - Yamaguchi University Hospital /ID# 265619
- Yamanashi
  - Chuo-shi, Yamanashi, Japan, 409-3898
    - Recruiting
    - University of Yamanashi Hospital /ID# 264677
Netherlands
- - Arnhem, Netherlands, 6815 AD
    - Completed
    - Rijnstate /ID# 261219
  - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Universitair Medisch Centrum Groningen /ID# 259051
- North Brabant
  - Roosendaal, North Brabant, Netherlands, 4708 AE
    - Completed
    - Bravis Ziekenhuis /ID# 259055
  - Tilburg, North Brabant, Netherlands, 5022 GC
    - Recruiting
    - Elisabeth Tweesteden Ziekenhuis /ID# 261239
- North Holland
  - Amsterdam, North Holland, Netherlands, 1091 AC
    - Completed
    - Olvg /Id# 259543
- South Holland
  - Leiden, South Holland, Netherlands, 2333 ZA
    - Recruiting
    - Leids Universitair Medisch Centrum /ID# 259049
  - Rotterdam, South Holland, Netherlands, 3045 PM
    - Recruiting
    - Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 259052
  - The Hague, South Holland, Netherlands, 2545 AA
    - Recruiting
    - HagaZiekenhuis /ID# 261220
- Utrecht
  - Nieuwegein, Utrecht, Netherlands, 3435 CM
    - Recruiting
    - St. Antonius Ziekenhuis /ID# 259053
    - Contact:
      
      Site Coordinator
      
      Phone Number: +31-883-206-002
New Zealand
- Auckland
  - Grafton, Auckland, New Zealand, 1023
    - Recruiting
    - Auckland City Hospital /ID# 259330
  - Takapuna, Auckland, New Zealand, 0622
    - Recruiting
    - North Shore Hospital /ID# 260824
Poland
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-175
    - Recruiting
    - Aidport sp z o.o. /ID# 267717
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-727
    - Recruiting
    - Pratia MCM Krakow /ID# 260075
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Recruiting
    - Narodowy Instytut Onkologii im. M. Sklodowskiej /ID# 260861
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 93-513
    - Recruiting
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 260633
- Świętokrzyskie Voivodeship
  - Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
    - Recruiting
    - Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 260170
Portugal
- - Lisbon, Portugal, 1649-035
    - Recruiting
    - Unidade Local de Saude de Santa Maria, EPE /ID# 259650
  - Porto, Portugal, 4200-072
    - Recruiting
    - Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 259649
- Lisbon District
  - Lisbon, Lisbon District, Portugal, 1400-038
    - Recruiting
    - Fundacao Champalimaud /ID# 259652
- Porto District
  - Vila Nova de Gaia, Porto District, Portugal, 4434-502
    - Recruiting
    - Unidade Local de Saude de Gaia/Espinho, EPE /ID# 259655
Puerto Rico
- - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - Pan American Center for Oncology Trials, LLC /ID# 260265
  - San Juan, Puerto Rico, 00918
    - Recruiting
    - Auxilio Mutuo Cancer Center /ID# 260262
    - Contact:
      
      Site Coordinator
      
      Phone Number: 787-758-2000 x 3569
Romania
- - Bucharest, Romania, 030171
    - Recruiting
    - Spitalul Clinic Coltea /ID# 259699
- Bucharest
  - Bucharest, Bucharest, Romania, 022328
    - Recruiting
    - Fundeni Clinical Institute /ID# 260296
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400015
    - Recruiting
    - Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 259704
- Iaşi
  - Iași, Iaşi, Romania, 700483
    - Recruiting
    - Institutul Regional de Oncologie /ID# 259697
Serbia
- - Novi Sad, Serbia, 21000
    - Recruiting
    - University Clinical Center Vojvodina /ID# 259272
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - University Clinical Center Serbia /ID# 259271
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Clinical Hospital Center Zvezdara /ID# 260900
- Sumadijski Okrug
  - Kragujevac, Sumadijski Okrug, Serbia, 34000
    - Recruiting
    - University Clinical Center Kragujevac /ID# 259274
- Vojvodina
  - Kamenitz, Vojvodina, Serbia, 21208
    - Recruiting
    - Institute for Oncology of Vojvodina /ID# 260223
Slovakia
- Bratislava Region
  - Bratislava, Bratislava Region, Slovakia, 833 10
    - Recruiting
    - Narodny onkologicky ustav /ID# 260638
- Žilina Region
  - Martin, Žilina Region, Slovakia, 036 01
    - Completed
    - Univerzitna nemocnica Martin /ID# 260631
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 1864
    - Recruiting
    - Wits Clinical Research /ID# 260958
  - Pretoria, Gauteng, South Africa, 0044
    - Recruiting
    - Alberts Cellular Therapy /ID# 260514
- Western Cape
  - Kuils River, Western Cape, South Africa, 7580
    - Recruiting
    - Haemalife Inc. /ID# 260513
South Korea
- Gyeonggido
  - Seongnam-si, Gyeonggido, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital /ID# 260009
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital /ID# 260007
  - Seoul, Seoul Teugbyeolsi, South Korea, 05505
    - Recruiting
    - Asan Medical Center /ID# 260010
  - Seoul, Seoul Teugbyeolsi, South Korea, 06351
    - Recruiting
    - Samsung Medical Center /ID# 260008
Spain
- - Barcelona, Spain, 08041
    - Recruiting
    - Hospital Santa Creu i Sant Pau /ID# 260498
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona /ID# 260492
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitario Vall de Hebron /ID# 260490
  - Cáceres, Spain, 10003
    - Recruiting
    - Hospital San Pedro de Alcantara /ID# 260502
  - Madrid, Spain, 28027
    - Recruiting
    - CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 261512
  - Madrid, Spain, 28033
    - Recruiting
    - MD Anderson Madrid /ID# 260500
  - Salamanca, Spain, 37711
    - Recruiting
    - Hospital Universitario de Salamanca /ID# 260491
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Recruiting
    - Instituto Catalan de Oncologia (ICO) Badalona /ID# 260495
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Recruiting
    - Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 261439
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Recruiting
    - Hospital Universitario Marques de Valdecilla /ID# 260497
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Recruiting
    - Clinica Universidad de Navarra - Pamplona /ID# 260496
Sweden
- Västra Götaland County
  - Borås, Västra Götaland County, Sweden, 501 82
    - Completed
    - Sodra Alvsborgs sjukhus /ID# 261168
  - Gothenburg, Västra Götaland County, Sweden, 413 46
    - Completed
    - Sahlgrenska Universitetssjukhuset /ID# 266600
Taiwan
- - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital /ID# 260357
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital /ID# 260361
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital /ID# 260363
- Taipei
  - Taipei City, Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital /ID# 260341
Turkey (Türkiye)
- - Istanbul, Turkey (Türkiye), 34899
    - Recruiting
    - Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 259804
  - Izmir, Turkey (Türkiye), 35100
    - Recruiting
    - Ege Universitesi Tip Fakultesi /ID# 259803
  - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Kocaeli University Med Faculty /ID# 259717
  - Samsun, Turkey (Türkiye), 55139
    - Recruiting
    - Ondokuz Mayis Universitesi /ID# 259713
- Istanbul
  - Şişli, Istanbul, Turkey (Türkiye), 34381
    - Recruiting
    - Istanbul Florence Nightingale Hospital /ID# 271291
United Kingdom
- - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie Hospital /ID# 260463
  - Newcastle upon Tyne, United Kingdom, NE3 3HD
    - Recruiting
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792
- Devon
  - Plymouth, Devon, United Kingdom, PL6 8DH
    - Recruiting
    - Derriford Hospital and the Royal Eye Infirmary /ID# 262671
- England
  - London, England, United Kingdom, W12 0HS
    - Recruiting
    - Hammersmith Hospital /ID# 261124
- Hampshire
  - Portsmouth, Hampshire, United Kingdom, PO6 3LY
    - Recruiting
    - Queen Alexandra Hospital /ID# 269708
- West Yorkshire
  - Leeds, West Yorkshire, United Kingdom, LS9 7TF
    - Recruiting
    - Leeds Teaching Hospitals NHS Trust /ID# 260466
United States
- California
  - Fresno, California, United States, 93701-2302
    - Recruiting
    - UCSF Fresno /ID# 264712
  - San Diego, California, United States, 92103
    - Recruiting
    - Scripps Mercy Hospital /ID# 265393
  - Santa Barbara, California, United States, 93105
    - Recruiting
    - Sansum Clinic Research /ID# 261596
- Colorado
  - Boulder, Colorado, United States, 80303
    - Recruiting
    - Rocky Mountain Cancer Centers - Boulder /ID# 261203
- Delaware
  - Newark, Delaware, United States, 19713
    - Recruiting
    - Christiana Care Health Service /ID# 261207
- Florida
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
    - Contact:
      
      Site Coordinator
      
      Phone Number: 904-538-4488
  - Orlando, Florida, United States, 32803
    - Recruiting
    - Advent Health /ID# 261578
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Orlando Health Cancer Institute /ID# 260983
  - Tampa, Florida, United States, 33612-9416
    - Recruiting
    - Moffitt Cancer Center /ID# 259487
- Idaho
  - Coeur d'Alene, Idaho, United States, 83814
    - Recruiting
    - Beacon Cancer Care /ID# 260670
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Cancer Care Specialists Of Central Illinois /ID# 272464
  - Maywood, Illinois, United States, 60153
    - Recruiting
    - Loyola University /ID# 259462
  - Peoria, Illinois, United States, 61615
    - Recruiting
    - Illinois Cancer Care, PC /ID# 261526
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Recruiting
    - Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583
- Iowa
  - Des Moines, Iowa, United States, 50314-3017
    - Recruiting
    - University of Iowa Health Care /ID# 262132
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Norton Cancer Institute - St. Matthews /ID# 261076
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville Hospital /ID# 260544
- Maine
  - Westbrook, Maine, United States, 04092
    - Recruiting
    - New England Cancer Specialists - Westbrook /ID# 260672
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - University of Maryland, Baltimore /ID# 259538
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Recruiting
    - St. Luke's Hospital - Chesterfield /ID# 260489
- Montana
  - Billings, Montana, United States, 59102
    - Recruiting
    - Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Recruiting
    - Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506
  - Lincoln, Nebraska, United States, 68506
    - Recruiting
    - NHO - Nebraska Hematology-Oncology /ID# 269692
  - Omaha, Nebraska, United States, 68130
    - Recruiting
    - Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505
  - Omaha, Nebraska, United States, 68198
    - Recruiting
    - University of Nebraska Medical Center /ID# 261996
- New Mexico
  - Albuquerque, New Mexico, United States, 87102-4517
    - Recruiting
    - University of New Mexico /ID# 261083
  - Albuquerque, New Mexico, United States, 87110
    - Recruiting
    - Presbyterian Kaseman Hospital /ID# 262451
  - Rio Rancho, New Mexico, United States, 87124
    - Recruiting
    - Presbyterian Rust Medical Center /ID# 262447
- New York
  - Albany, New York, United States, 12206-5013
    - Completed
    - New York Oncology Hematology - Albany Cancer Center /ID# 261814
  - Mineola, New York, United States, 11501
    - Recruiting
    - NYU Langone Hospital - Long Island /ID# 265531
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mount Sinai /ID# 259595
  - New York, New York, United States, 10016-6402
    - Recruiting
    - NYU Langone Medical Center /ID# 264518
  - Troy, New York, United States, 12180
    - Recruiting
    - New York Oncology Hematology /ID# 270208
  - Westbury, New York, United States, 11590
    - Recruiting
    - Clinical Research Alliance - Westbury /ID# 261078
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Novant Health Presbyterian Medical Center /ID# 259740
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Novant Health Forsyth Medical Center /ID# 259741
- Ohio
  - Cincinnati, Ohio, United States, 45252
    - Recruiting
    - Oncology Hematology Care, Inc - Blue Ash /ID# 261204
  - Maumee, Ohio, United States, 43537-1921
    - Completed
    - Taylor Cancer Research Center /ID# 260488
- Oregon
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Oncology Associates of Oregon, P.C. /ID# 261816
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - MUSC Hollings Cancer Center /ID# 259604
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Prisma Health /ID# 259602
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Sarah Cannon Research Institute - Tristar Centennial Medical Center /ID# 274985
- Texas
  - Austin, Texas, United States, 78705
    - Recruiting
    - Texas Oncology - Austin Midtown /ID# 261208
  - Dallas, Texas, United States, 75246-2003
    - Recruiting
    - Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206
  - Houston, Texas, United States, 77030-4000
    - Recruiting
    - MD Anderson Cancer Center /ID# 260984
  - Houston, Texas, United States, 77030
    - Recruiting
    - Oncology Consultants /ID# 268390
  - Lubbock, Texas, United States, 79410
    - Recruiting
    - Joe Arrington Cancer Research /ID# 260382
- Utah
  - Salt Lake City, Utah, United States, 84143
    - Recruiting
    - Intermountain Healthcare LDS Hospital /ID# 259759
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Virginia Cancer Specialists - Fairfax /ID# 261205
  - Roanoke, Virginia, United States, 98684
    - Recruiting
    - Oncology and Hematology Associates of Southwest Virginia /ID# 261592
- Washington
  - Edmonds, Washington, United States, 98026
    - Recruiting
    - Swedish Cancer Institute - Edmonds /ID# 266356
  - Issaquah, Washington, United States, 98029
    - Recruiting
    - Swedish Cancer Institute - Issaquah /ID# 266358
  - Olympia, Washington, United States, 98506-5028
    - Recruiting
    - Vista Oncology - East Olympia /ID# 261360
  - Seattle, Washington, United States, 98101
    - Recruiting
    - Virginia Mason Hospital & Medical Center /ID# 260549
  - Seattle, Washington, United States, 98104
    - Recruiting
    - Swedish Medical Center - Seattle /ID# 260370
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Northwest Medical Specialties - Tacoma /ID# 262133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Obinutuzumab IV Infusion Drug: Prednisone Oral Tablet Drug: Cyclophosphamide IV Injection Drug: Rituximab Intravenous (IV) Infusion Drug: Doxorubicin IV Injection Drug: Vincristine IV Injection
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.	Drug: Obinutuzumab IV Infusion Drug: Prednisone Oral Tablet Drug: Rituximab Intravenous (IV) Infusion Drug: Bendamustine IV Infusion
Experimental: Arm C: Lenalidomide and Rituximab (R2) Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.	Drug: Rituximab Intravenous (IV) Infusion Drug: Lenalidomide Oral Capsule
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.	Drug: Rituximab Intravenous (IV) Infusion Drug: Lenalidomide Oral Capsule Drug: Epcoritamab Subcutaneous (SC) Injection Other Names: GEN3013 ABBV-GMAB-3013 Epkinly
Experimental: Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2) Participants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.	Drug: Rituximab Intravenous (IV) Infusion Drug: Lenalidomide Oral Capsule Drug: Epcoritamab Subcutaneous (SC) Injection Other Names: GEN3013 ABBV-GMAB-3013 Epkinly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30) Time Frame: Up to 30 Months	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).	Up to 30 Months
Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS) Time Frame: Up to 10 Years	PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.	Up to 10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm A1 vs Arm B: Overall Survival (OS) Time Frame: Up to 10 Years	OS is defined as the time from the date of randomization to the date of death of any cause.	Up to 10 Years
Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate Time Frame: Up to 10 Years	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.	Up to 10 Years
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) Time Frame: 21 Weeks	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.	21 Weeks
Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30 Time Frame: Up to 30 Months	CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.	Up to 30 Months
Arm A1 vs Arm C: Percentage of Participants who Achieve CR30 Time Frame: Up to 30 Months	CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.	Up to 30 Months
Arm A1 vs Arm A2: Number of Participants with PFS Time Frame: Up to 10 Years	PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with PFS Time Frame: Up to 10 Years	PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm A2: Rate of MRD Negativity Time Frame: Up to 10 Years	MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.	Up to 10 Years
Arm A1 vs Arm C: Rate of MRD Negativity Time Frame: Up to 10 Years	MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.	Up to 10 Years
Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: OS Time Frame: Up to 10 Years	OS is defined as the time from the date of randomization to the date of death of any cause.	Up to 10 Years
Arm A1 vs Arm C: OS Time Frame: Up to 10 Years	OS is defined as the time from the date of randomization to the date of death of any cause.	Up to 10 Years
Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30 Time Frame: Up to 30 Months	CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.	Up to 30 Months
Arm A1 vs Arm B: Percentage of Participants who Achieve CR30 Time Frame: Up to 30 Months	CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.	Up to 30 Months
Arm A1 vs Arm C: Percentage of Participants who Achieve CR30 Time Frame: Up to 30 Months	CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.	Up to 30 Months
Arm A1 vs Arm A2: Number of Participants with PFS Time Frame: Up to 10 Years	PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm B: Number of Participants with PFS Time Frame: Up to 10 Years	PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with PFS Time Frame: Up to 10 Years	PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC Time Frame: Up to 10 Years	CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator Time Frame: Up to 10 Years	CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC Time Frame: Up to 10 Years	CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator Time Frame: Up to 10 Years	CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC Time Frame: Up to 10 Years	CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator Time Frame: Up to 10 Years	CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with Best Overall Response (BOR) per per Investigator Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with BOR per IRC Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Number of Participants with BOR per Investigator Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Number of Participants with BOR per IRC Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with BOR per Investigator Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with BOR per IRC Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with Event-free Survival (EFS) per IRC Time Frame: Up to 10 Years	EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with EFS per Investigator Time Frame: Up to 10 Years	EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm B: Number of Participants with EFS per IRC Time Frame: Up to 10 Years	EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm B: Number of Participants with EFS per Investigator Time Frame: Up to 10 Years	EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with EFS per IRC Time Frame: Up to 10 Years	EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with EFS per Investigator Time Frame: Up to 10 Years	EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.	Up to 10 Years
Arm A1 vs Arm A2: Duration of Response (DOR) per IRC Time Frame: Up to 10 Years	DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm A2: DOR per Investigator Time Frame: Up to 10 Years	DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm B: DOR per IRC Time Frame: Up to 10 Years	DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm B: DOR per Investigator Time Frame: Up to 10 Years	DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm C: DOR per IRC Time Frame: Up to 10 Years	DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm C: DOR per Investigator Time Frame: Up to 10 Years	DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRC Time Frame: Up to 10 Years	DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm A2: DOCR per Investigator Time Frame: Up to 10 Years	DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm B: DOCR per IRC Time Frame: Up to 10 Years	DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm B: DOCR per Investigator Time Frame: Up to 10 Years	DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm C: DOCR per IRC Time Frame: Up to 10 Years	DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm C: DOCR per Investigator Time Frame: Up to 10 Years	DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per Investigator Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm A2: TTNT per IRC Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm A2: TTNT per Investigator Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm B: TTNT per IRC Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm B: TTNT per Investigator Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm C: TTNT per IRC Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm C: TTNT per Investigator Time Frame: Up to 10 Years	TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.	Up to 10 Years
Arm A1 vs Arm A2: Time to Progression per IRC Time Frame: Up to 10 Years	Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm A2: Time to Progression per Investigator Time Frame: Up to 10 Years	Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm B: Time to Progression per IRC Time Frame: Up to 10 Years	Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm B: Time to Progression per Investigator Time Frame: Up to 10 Years	Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm C: Time to Progression per IRC Time Frame: Up to 10 Years	Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.	Up to 10 Years
Arm A1 vs Arm C: Time to Progression per Investigator Time Frame: Up to 10 Years	Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.	Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2) Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Number of Participants with PFS2 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Number of Participants with PFS2 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change in Tolerability as Measured by PRO-CTCAE Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change in Tolerability as Measured by PRO-CTCAE Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5 Time Frame: Up to 10 Years	The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.	Up to 10 Years
Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5 Time Frame: Up to 10 Years	The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.	Up to 10 Years
Arm A1 vs Arm A2: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change in Symptoms as Measured by FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change in Symptoms as Measured by FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change in Quality of Life (QoL) as Measured by FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change in QoL as Measured by FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change in QoL as Measured by FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Time-to-first PRO deterioration (TTD) in well-being using the lymphoma subscale (LymS) of FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: TTD in well-being using LymS of FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: TTD in well-being using LymS of FACT-Lym Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L] Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change in QoL as Measured by EQ-5D-5L Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change in QoL as Measured by EQ-5D-5L Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: TTD in PF using the QLQ-C30 Physical Functioning Scale Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: TTD in PF using the QLQ-C30 Physical Functioning Scale Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: TTD in PF using the QLQ-C30 Physical Functioning Scale Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30 Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change in Patient Global Impression of Change (PGIC) for General Lymphoma Symptoms Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change in PGIC for General Lymphoma Symptoms Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm A2: Change in Patient Global Impression of Severity (PGIS) for General Lymphoma Symptoms Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm B: Change in PGIS for General Lymphoma Symptoms Time Frame: Up to 10 Years	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.	Up to 10 Years
Arm A1 vs Arm C: Change in PGIS for General Lymphoma Symptoms Time Frame: Up to 10 Years	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.	Up to 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

November 1, 2037

Study Completion (Estimated)

November 1, 2037

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M22-003
2023-506906-38-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

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Enrollment (Estimated)

Phase

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Study Contact

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Ages Eligible for Study

Accepts Healthy Volunteers

Description

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Design Details

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Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

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Outcome Measure

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Publications and helpful links

Helpful Links

Study record dates

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More Information

Terms related to this study

Keywords

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Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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