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JOURNAL ONKOLOGIE – STUDIE
EPCORE FL-1

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

Rekrutierend

NCT-Nummer:
NCT05409066

Studienbeginn:
September 2022

Letztes Update:
09.04.2024

Wirkstoff:
Epcoritamab, Rituximab, Lenalidomide

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Follicular

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AbbVie

Collaborator:
Genmab

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

Studienlocations
(3 von 234)

Universitaetsklinikum Tuebingen /ID# 229663
72076 Tubingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Giessen /ID# 234245
35392 Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig /ID# 242907
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Jena /ID# 232064
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Sozialstiftung Bamberg /ID# 229184
96049 Bamberg
(Bayern)
GermanyRekrutierend» Google-Maps
Helios Klinikum Berlin-Buch /ID# 229178
13125 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
Universitaetsklinikum Bonn /ID# 249401
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 229754
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen /ID# 229180
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum Kassel /ID# 229185
34125 Kassel
(Hessen)
GermanyRekrutierend» Google-Maps
Otto-von-Guericke-Universitaet /ID# 230144
39120 Magdeburg
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Klinikum Mutterhaus der Borromäerinnen /ID# 232354
54290 Trier
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Wuerzburg /ID# 229278
97080 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps
University of Arizona Cancer Center - North Campus /ID# 228862
85719-1478 Tucson
United StatesRekrutierend» Google-Maps
Long Beach Memorial Medical Ct /ID# 228997
90806-1701 Long Beach
United StatesRekrutierend» Google-Maps
University of Southern California /ID# 227195
90033 Los Angeles
United StatesRekrutierend» Google-Maps
Northwestern University Feinberg School of Medicine /ID# 227248
60611-2927 Chicago
United StatesRekrutierend» Google-Maps
Goshen Center for Cancer Care /ID# 227189
46526 Goshen
United StatesRekrutierend» Google-Maps
UMass Memorial Medical Center /ID# 227323
01605 Worcester
United StatesRekrutierend» Google-Maps
St. Luke's Hospital - Chesterfield /ID# 247817
63017 Chesterfield
United StatesRekrutierend» Google-Maps
Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220
59102 Billings
United StatesRekrutierend» Google-Maps
Morristown Medical Center /ID# 231427
07960-6136 Morristown
United StatesRekrutierend» Google-Maps
Perlmutter Cancer Center at NYU Langone /ID# 253343
11501-4064 Mineola
United StatesRekrutierend» Google-Maps
Laura and Isaac Perlmutter Cancer Center at NYU Langone /ID# 227322
10016-2708 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193
10065-6007 New York
United StatesRekrutierend» Google-Maps
Fundaleu /Id# 229700
1114 Ciudad Autonoma de Buenos Aire
ArgentinaRekrutierend» Google-Maps
Cemic /Id# 229697
1431 Ciudad Autonoma de Buenos Aire
ArgentinaRekrutierend» Google-Maps
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 229701
5016 Cordoba
ArgentinaRekrutierend» Google-Maps
Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124
3000 Santa Fe
ArgentinaRekrutierend» Google-Maps
Royal Prince Alfred Hospital /ID# 239272
2050 Camperdown
AustraliaRekrutierend» Google-Maps
Nepean Hospital /ID# 239093
2747 Kingswood
AustraliaRekrutierend» Google-Maps
Townsville University Hospital /ID# 231124
4814 Douglas
AustraliaRekrutierend» Google-Maps
Peninsula Private Hospital /ID# 238796
3199 Frankston
AustraliaRekrutierend» Google-Maps
Fiona Stanley Hospital /ID# 231122
6150 Murdoch
AustraliaRekrutierend» Google-Maps
Hollywood Medical Centre /ID# 251789
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Royal Perth Hospital /ID# 230456
6000 Perth
AustraliaRekrutierend» Google-Maps
Universitaetsklinikum St. Poelten /ID# 234015
3100 Sankt Poelten
AustriaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen /ID# 247510
4010 Linz
AustriaRekrutierend» Google-Maps
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 228366
5020 Salzburg
AustriaRekrutierend» Google-Maps
Hospital La Louviere Site Jolimont - Helora /ID# 228520
7100 La Louvière
BelgiumRekrutierend» Google-Maps
Universitair Ziekenhuis Leuven /ID# 247780
3000 Leuven
BelgiumRekrutierend» Google-Maps
Groupe Sante CHC - Clinique du MontLegia /ID# 230415
4000 Liege
BelgiumRekrutierend» Google-Maps
AZ Turnhout - Campus Sint-Elisabeth /ID# 231628
2300 Turnhout
BelgiumRekrutierend» Google-Maps
Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
80060-900 Curitiba
BrazilRekrutierend» Google-Maps
Upeclin Fmb - Unesp /Id# 252912
18618-686 Botucatu
BrazilRekrutierend» Google-Maps
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 228129
17210-070 Jaú
BrazilRekrutierend» Google-Maps
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130
01509-900 São Paulo
BrazilRekrutierend» Google-Maps
Instituto Nacional de Cancer (INCA) /ID# 228706
20231-050 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121
01323-001 Sao Paulo
BrazilRekrutierend» Google-Maps
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 252918
01401-002 Sao Paulo
BrazilRekrutierend» Google-Maps
Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182
04039-901 Sao Paulo
BrazilRekrutierend» Google-Maps
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 228127
05403-000 Sao Paulo
BrazilRekrutierend» Google-Maps
Cross Cancer Institute /ID# 249080
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
BC Cancer - Victoria /ID# 228850
V8R 6V5 Victoria
CanadaRekrutierend» Google-Maps
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896
G6V 3Z1 Levis
CanadaRekrutierend» Google-Maps
CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537
G1J 1Z4 Quebec City
CanadaRekrutierend» Google-Maps
CISSSBSL -Hopital regional de Rimouski /ID# 229894
G5L 5T1 Rimouski
CanadaRekrutierend» Google-Maps
Peking University First Hospital /ID# 250517
100034 Beijing
ChinaRekrutierend» Google-Maps
Peking University Third Hospital /ID# 230885
100191 Beijing
ChinaRekrutierend» Google-Maps
Fujian Medical University Union Hospital /ID# 233919
350001 Fuzhou
ChinaRekrutierend» Google-Maps
Sun Yat-Sen University Cancer Center /ID# 231463
510060 Guangzhou
ChinaRekrutierend» Google-Maps
Guangdong Provincial Peoples Hospital(Huifu Campus) /ID# 232512
510120 Guangzhou
ChinaRekrutierend» Google-Maps
Nanfang Hospital of Southern Medical University /ID# 230383
510515 Guangzhou
ChinaRekrutierend» Google-Maps
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234153
430022 Wuhan
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Site Coordinator
Phone: 027-83802833
» Ansprechpartner anzeigen
Hubei Cancer Hospital /ID# 232255
430079 Wuhan
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Soochow University /ID# 232511
215006 Suzhou
ChinaRekrutierend» Google-Maps
The Affiliated Hospital of Xuzhou Medical College /ID# 232513
221006 Xuzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University /ID# 231047
330006 Nanchang
ChinaRekrutierend» Google-Maps
Jiangxi Provincial Cancer Hospital /ID# 232507
330029 Nanchang
ChinaRekrutierend» Google-Maps
The First Hospital of China Medical University /ID# 232509
110001 Shenyang
ChinaRekrutierend» Google-Maps
Fudan University Cancer Hospital /ID# 250475
200032 Shanghai
ChinaRekrutierend» Google-Maps
Tianjin Cancer Hospital /ID# 230876
300000 Tianjin
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390
310003 Hangzhou
ChinaRekrutierend» Google-Maps
The second affiliated hospital of Zhejiang University school of medicine /ID# 231250
310009 Hangzhou
ChinaRekrutierend» Google-Maps
Zhejiang Cancer hospital /ID# 231389
310022 Hangzhou
ChinaRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove /ID# 228269
500 05 Hradec Kralove
CzechiaRekrutierend» Google-Maps
Duplicate_Fakultni Nemocnice v Motole /ID# 228272
150 00 Prague
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady /ID# 228564
100 34 Praha
CzechiaRekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze /ID# 228565
128 08 Praha
CzechiaRekrutierend» Google-Maps
Regionshospitalet Godstrup /ID# 227466
7400 Herning
DenmarkRekrutierend» Google-Maps
Sygehus Lillebalt, Vejle /ID# 227404
7100 Vejle
DenmarkRekrutierend» Google-Maps
CHU Clermont-Ferrand /ID# 238676
63100 Clermont
FranceRekrutierend» Google-Maps
CHU de Rennes - PONTCHAILLOU /ID# 230356
35000 Rennes
FranceRekrutierend» Google-Maps
CHU Limoges - Dupuytren 1 /ID# 231450
87042 Limoges CEDEX 1
FranceRekrutierend» Google-Maps
CHU NIMES - Hopital Caremeau /ID# 230351
30029 Nimes CEDEX 9
FranceRekrutierend» Google-Maps
CHU Bordeaux - Hopital Haut Leveque /ID# 230347
33604 Pessac
FranceRekrutierend» Google-Maps
CHU Reims - Hôpital Robert Debre /ID# 248710
51092 Reims CEDEX
FranceRekrutierend» Google-Maps
CHRU Nancy - Hopitaux de Brabois /ID# 241595
54500 Vandoeuvre-les-Nancy
FranceRekrutierend» Google-Maps
CHRU Lille - Hopital Claude Huriez /ID# 230353
59037 Lille
FranceRekrutierend» Google-Maps
CHU de Nantes, Hotel Dieu -HME /ID# 245928
44000 Nantes
FranceRekrutierend» Google-Maps
Centre Leon Berard /ID# 230348
69373 Lyon CEDEX 08
FranceRekrutierend» Google-Maps
HCL - Hopital Lyon Sud /ID# 231449
69495 Pierre Benite CEDEX
FranceRekrutierend» Google-Maps
CHU Poitiers - La miletrie /ID# 230357
86000 Poitiers
FranceRekrutierend» Google-Maps
CHU de CAEN - Hopital de la Cote de Nacre /ID# 245929
14033 Caen
FranceRekrutierend» Google-Maps
Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 230358
94010 Créteil
FranceRekrutierend» Google-Maps
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095
85000 La Roche Sur Yon
FranceRekrutierend» Google-Maps
AP-HP - Hopital Saint-Louis /ID# 232067
75010 Paris
FranceRekrutierend» Google-Maps
Hopital Pitie Salpetriere /ID# 230360
75013 Paris
FranceRekrutierend» Google-Maps
IUCT Oncopole /ID# 233486
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
General Hospital of Athens Laiko /ID# 226626
11527 Athens
GreeceRekrutierend» Google-Maps
Alexandra General Hospital /ID# 226632
11528 Athens
GreeceRekrutierend» Google-Maps
University General Hospital Attikon /ID# 226629
12462 Athens
GreeceRekrutierend» Google-Maps
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633
10676 Athens
GreeceRekrutierend» Google-Maps
University General Hospital of Ioannina /ID# 226628
45500 Ioannina
GreeceRekrutierend» Google-Maps
General University Hospital of Thessaloniki AXEPA /ID# 226630
54636 Thessaloniki
GreeceRekrutierend» Google-Maps
Theageneio Anticancer Hospital /ID# 226627
54639 Thessaloniki
GreeceRekrutierend» Google-Maps
Debreceni Egyetem-Klinikai Kozpont /ID# 229287
4032 Debrecen
HungaryRekrutierend» Google-Maps
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 246475
7400 Kaposvár
HungaryRekrutierend» Google-Maps
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 232203
4400 Nyiregyhaza
HungaryRekrutierend» Google-Maps
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 229290
9700 Szombathely
HungaryRekrutierend» Google-Maps
Semmelweis Egyetem /ID# 229291
1085 Budapest
HungaryRekrutierend» Google-Maps
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286
1097 Budapest
HungaryRekrutierend» Google-Maps
Orszagos Onkologiai Intezet /ID# 229292
1122 Budapest
HungaryRekrutierend» Google-Maps
Szegedi Tudományegyetem /ID# 229289
6720 Szeged
HungaryRekrutierend» Google-Maps
Rambam Health Care Campus /ID# 227849
3109601 Haifa
IsraelRekrutierend» Google-Maps
Rabin Medical Center /ID# 228043
4941492 Haifa
IsraelRekrutierend» Google-Maps
Assaf Harofeh Medical Center /ID# 228037
70300 Zerifin
IsraelRekrutierend» Google-Maps
The Chaim Sheba Medical Center /ID# 228322
5265601 Ramat Gan
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center /ID# 228529
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458
71013 San Giovanni Rotondo
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402
00168 Rome
ItalyRekrutierend» Google-Maps
Ospedale San Raffaele IRCCS /ID# 228669
20132 Milan
ItalyRekrutierend» Google-Maps
IEO -Istituto Europeo di Oncologia /ID# 227396
20141 Milan
ItalyRekrutierend» Google-Maps
AOU Citta della Salute e della Scienza di Torino /ID# 229820
10126 Torino
ItalyRekrutierend» Google-Maps
Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602
10060 Candiolo
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401
15100 Alessandria
ItalyRekrutierend» Google-Maps
Centro di Riferimento Oncologico /ID# 227395
33081 Aviano
ItalyRekrutierend» Google-Maps
ASST Spedali civili di Brescia /ID# 227397
25123 Brescia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Federico II /ID# 230403
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399
28100 Novara
ItalyRekrutierend» Google-Maps
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402
90146 Palermo
ItalyRekrutierend» Google-Maps
Ospedale Santa Maria delle Croci /ID# 227394
48121 Ravenna
ItalyRekrutierend» Google-Maps
NHO Nagoya Medical Center /ID# 230678
460-0001 Nagoya-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East /ID# 232423
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
Matsuyama Red Cross Hospital /ID# 251866
790-8524 Matsuyama-shi
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center /ID# 252245
811-1395 Fukuoka-shi
JapanRekrutierend» Google-Maps
Kyushu University Hospital /ID# 230136
812-8582 Fukuoka-shi
JapanRekrutierend» Google-Maps
Fukushima Medical University Hospital /ID# 251839
960-1295 Fukushima-shi
JapanRekrutierend» Google-Maps
Hokkaido University Hospital /ID# 231443
060-8648 Sapporo-shi
JapanRekrutierend» Google-Maps
Kobe City Medical Center General Hospital /ID# 251945
650-0047 Kobe-shi
JapanRekrutierend» Google-Maps
Kagoshima University Hospital /ID# 232251
890-8520 Kagoshima-shi
JapanRekrutierend» Google-Maps
Tokai University Hospital /ID# 252135
259-1193 Isehara-shi
JapanRekrutierend» Google-Maps
Kyoto University Hospital /ID# 231156
606-8507 Kyoto-shi
JapanRekrutierend» Google-Maps
Mie University Hospital /ID# 251944
514-8507 Tsu-shi
JapanRekrutierend» Google-Maps
Tohoku University Hospital /ID# 232303
9808574 Sendai-shi
JapanRekrutierend» Google-Maps
Shinshu University Hospital /ID# 252246
390-8621 Matsumoto-shi
JapanRekrutierend» Google-Maps
Okayama University Hospital /ID# 232009
700-8558 Okayama-shi
JapanRekrutierend» Google-Maps
Kindai University Hospital /ID# 232152
589-8511 Osakasayama-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital /ID# 230004
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital Of JFCR /ID# 230271
135-8550 Koto-ku
JapanRekrutierend» Google-Maps
Yamagata University Hospital /ID# 230005
990-9585 Yamagata-shi
JapanRekrutierend» Google-Maps
Seoul National University Bundang Hospital /ID# 228448
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center /ID# 228444
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 228447
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Inje University Busan Paik Hospital /ID# 230293
47392 Busan
Korea, Republic ofRekrutierend» Google-Maps
Dong-A University Hospital /ID# 228638
49201 Busan
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital /ID# 229798
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Keimyung University Dongsan Medical Center /ID# 229800
41931 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Jeonbuk National University Hospital /ID# 228908
54907 Jeonju
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital /ID# 228446
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center /ID# 228445
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Dijklander Ziekenhuis /ID# 248993
1624 NP Hoorn Nh
NetherlandsRekrutierend» Google-Maps
Albert Schweitzer Ziekenhuis /ID# 247740
3318 AT Dordrecht
NetherlandsRekrutierend» Google-Maps
Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 248139
3045 PM Rotterdam
NetherlandsRekrutierend» Google-Maps
Onze Lieve Vrouwe Gasthuis /ID# 247899
1091 AC Amsterdam
NetherlandsRekrutierend» Google-Maps
Amphia Ziekenhuis /ID# 247739
4818 CK Breda
NetherlandsRekrutierend» Google-Maps
Deventer Ziekenhuis /ID# 247853
7416 SE Deventer
NetherlandsAbgeschlossen» Google-Maps
Medisch Spectrum Twente /ID# 247854
7512 KZ Enschede
NetherlandsRekrutierend» Google-Maps
Admiraal de Ruyter Ziekenhuis /ID# 247692
4462 RA Goes
NetherlandsRekrutierend» Google-Maps
Universitair Medisch Centrum Groningen /ID# 247741
9713 GZ Groningen
NetherlandsRekrutierend» Google-Maps
Leids Universitair Medisch Centrum /ID# 247742
2333 ZA Leiden
NetherlandsRekrutierend» Google-Maps
St. Antonius Ziekenhuis /ID# 248644
3435 CM Nieuwegein
NetherlandsRekrutierend» Google-Maps
Canisius-Wilhelmina Ziekenhuis /ID# 248138
6532 SZ Nijmegen
NetherlandsRekrutierend» Google-Maps
Aotearoa Clinical Trials /ID# 228509
2025 Papatoetoe
New ZealandRekrutierend» Google-Maps
North Shore Hospital /ID# 228508
0622 Takapuna
New ZealandRekrutierend» Google-Maps
Palmerston North Hospital /ID# 232352
4442 Palmerston North
New ZealandRekrutierend» Google-Maps
Pratia MCM Krakow /ID# 229121
30-727 Krakow
PolandRekrutierend» Google-Maps
Szpitale Pomorskie Sp. z o.o /ID# 229122
81-519 Gdynia
PolandRekrutierend» Google-Maps
Swietokrzyskie Centrum Onkologii /ID# 229362
25-734 Kielce
PolandRekrutierend» Google-Maps
ARS-MEDICAL Sp. z o.o. /ID# 229601
64-920 Pila
PolandAbgeschlossen» Google-Maps
Centrum Medyczne Promed - Skorzewo /ID# 229299
60-185 Skorzewo
PolandRekrutierend» Google-Maps
Pan American Center for Oncology Trials, LLC /ID# 230055
00935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
Wits Clinical Research Site /ID# 228895
2193 Johannesburg
South AfricaRekrutierend» Google-Maps
Alberts Cellular Therapy /ID# 228896
0044 Pretoria
South AfricaRekrutierend» Google-Maps
University of Cape Town /ID# 228900
7925 Cape Town
South AfricaRekrutierend» Google-Maps
Haemalife Inc. /ID# 243392
7580 Kuilsrivier
South AfricaRekrutierend» Google-Maps
Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108
08916 Badalona
SpainRekrutierend» Google-Maps
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 228107
08908 Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitario Marques de Valdecilla /ID# 228984
39008 Santander
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra - Pamplona /ID# 228116
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Parc de Salut del Mar /ID# 228106
08003 Barcelona
SpainRekrutierend» Google-Maps
Hospital Santa Creu i Sant Pau /ID# 229859
08041 Barcelona
SpainRekrutierend» Google-Maps
Hospital San Pedro de Alcantara /ID# 248845
10003 Caceres
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia /ID# 228122
14004 Cordoba
SpainRekrutierend» Google-Maps
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157
28027 Madrid
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Studien-Informationen

Brief Summary:

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of

cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment

and the disease recurs in almost all patients. This study will assess how safe and effective

epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult

participants with relapsed or refractory (R/R) FL. Adverse events and change in disease

condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors

put the participants in 1 of 3 groups, called treatment arms. Each group receives a different

treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R

FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and

oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with

subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their

standard of care. Participants will attend regular visits during the study at a hospital or

clinic. The effect of the treatment will be checked by medical assessments, blood tests,

checking for side effects and completing questionnaires.

Ein-/Ausschlusskriterien

Inclusion Criteria:

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

- Participant has:

- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating

positive lesion compatible with computed tomography (CT) or magnetic resonance

image (MRI)-defined anatomical tumor sites AND

- >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal

lesion (long axis > 1.0 cm) on CT scan or MRI.

- Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a

FL] stage II, III, or IV with no evidence of histologic transformation to an

aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based

on the pathology report.

- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that

contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy.

(Participant who received only prior anti-CD20 mAb monotherapy and/or radiation

therapy is not eligible.)

- Eligible to receive R2 per investigator determination.

Exclusion Criteria:

- Documented refractoriness to lenalidomide.

- Have lenalidomide exposure within 12 months prior to randomization.

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to approximately 5 years):
PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).



Secondary outcome:

1. Percentage of Participants Achieving Complete Response (CR) (Time Frame - Up to approximately 5 years):
Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.

2. Overall Survival (OS) (Time Frame - Up to approximately 8 years from randomization):
Overall survival is defined as the duration from the date of randomization to the date of the participant's death.

3. Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity (Time Frame - Up to approximately 5 years):
MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.

Studien-Arme

  • Experimental: Epcoritamab Dose A in Combination With R2
    Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
  • Experimental: Epcoritamab Dose B in Combination With R2
    Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
  • Active Comparator: Lenalidomide and Rituximab (R2)
    Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).

Geprüfte Regime

  • Epcoritamab (GEN3013):
    Subcutaneous Injection
  • Rituximab:
    Intravenous Infusion
  • Lenalidomide:
    Oral Capsules

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

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

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