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

Sponsor

AbbVie (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05409066

Collaborator

Genmab (Industry)

642

Enrollment

268

Locations

Arms

87.7

Anticipated Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (intravenous infusion of rituximab up to 5 cycles and oral capsules of 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.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma (FL)	Drug: Epcoritamab Drug: Rituximab Drug: Lenalidomide	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

642 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)

Anticipated Study Start Date :

Sep 7, 2022

Anticipated Primary Completion Date :

Dec 27, 2029

Anticipated Study Completion Date :

Dec 27, 2029

Arms and Interventions

Arm	Intervention/Treatment
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).	Drug: Epcoritamab Subcutaneous Injection Other Names: GEN3013 Drug: Rituximab Intravenous Infusion Drug: Lenalidomide Oral Capsules
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).	Drug: Epcoritamab Subcutaneous Injection Other Names: GEN3013 Drug: Rituximab Intravenous Infusion Drug: Lenalidomide Oral Capsules
Active Comparator: Lenalidomide and Rituximab (R2) Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).	Drug: Rituximab Intravenous Infusion Drug: Lenalidomide Oral Capsules

Arm

Intervention/Treatment

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).

Drug: Epcoritamab

Subcutaneous Injection

Other Names:

GEN3013

Drug: Rituximab

Intravenous Infusion

Drug: Lenalidomide

Oral Capsules

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).

Drug: Epcoritamab

Subcutaneous Injection

Other Names:

GEN3013

Drug: Rituximab

Intravenous Infusion

Drug: Lenalidomide

Oral Capsules

Active Comparator: Lenalidomide and Rituximab (R2)

Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).

Drug: Rituximab

Intravenous Infusion

Drug: Lenalidomide

Oral Capsules

Outcome Measures

Primary Outcome Measures

Progression-Free Survival (PFS) [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 Measures

Percentage of Participants Achieving Complete Response (CR) [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.
Percentage of Participants Achieving Best Overall Response (BOR) [Up to approximately 5 years]
Percentage of participants who achieve the BOR of complete response (CR) or partial response (PR) determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.
Overall Survival (OS) [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.
Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.
Histologically confirmed Grade 1 to 3a follicular lymphoma (FL) according to the World Health Organization (WHO) 2016 classification with no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy and CD20+ on a 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 (an)other anti-lymphoma agent(s).
Eligible to receive R2 per investigator determination.

Exclusion Criteria:

Documented refractoriness to lenalidomide.
Have lenalidomide exposure within 12 months prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sutter Health Alta Bates Summit Medical Center /ID# 229428	Berkeley	California	United States	94705-2067
2	Providence St. Joseph Medical center /ID# 228835	Burbank	California	United States	91505
3	Orange Coast Medical Center /ID# 229634	Fountain Valley	California	United States	92708-6728
4	Marin Cancer Care /ID# 227207	Greenbrae	California	United States	94904
5	Saddleback Memorial Medical Center /ID# 229633	Laguna Hills	California	United States	92653-3689
6	Long Beach Memorial Medical Ct /ID# 228997	Long Beach	California	United States	90806-1701
7	University of Southern California /ID# 227195	Los Angeles	California	United States	90033
8	Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228619	Aurora	Colorado	United States	80014
9	Christiana Care Health Service /ID# 228268	Newark	Delaware	United States	19713
10	Holy Cross Hospital /ID# 228541	Fort Lauderdale	Florida	United States	33308
11	Baptist MD Anderson Cancer Center - Jacksonville /ID# 227270	Jacksonville	Florida	United States	32207-8432
12	Emory University /ID# 227299	Atlanta	Georgia	United States	30322-1013
13	Augusta University Georgia Cancer Center /ID# 227313	Augusta	Georgia	United States	30912-0003
14	Northwestern University /ID# 227248	Chicago	Illinois	United States	60611-2927
15	Southern IL Univ School of Med /ID# 229000	Springfield	Illinois	United States	62702
16	Goshen Center for Cancer Care /ID# 227189	Goshen	Indiana	United States	46526
17	Univ Maryland School Medicine /ID# 227191	Baltimore	Maryland	United States	21201-1544
18	Massachusetts General Hospital /ID# 245233	Boston	Massachusetts	United States	02114
19	UMass Chan Medical School /ID# 227323	Worcester	Massachusetts	United States	01655
20	Henry Ford Health System /ID# 227250	Detroit	Michigan	United States	48202
21	Mmcorc /Id# 227177	Saint Louis Park	Minnesota	United States	55416
22	Alliance for Multispecialty Research (AMR) - Kansas City /ID# 231075	Kansas City	Missouri	United States	64114-4859
23	Morristown Medical Center /ID# 231427	Morristown	New Jersey	United States	07960-6136
24	Roswell Park Comprehensive Cancer Center /ID# 239128	Buffalo	New York	United States	14263
25	NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 227322	New York	New York	United States	10016-4744
26	Icahn School of Medicine at Mount Sinai /ID# 227181	New York	New York	United States	10029-6504
27	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193	New York	New York	United States	10065-6007
28	Novant Health Presbyterian Medical Center /ID# 228182	Charlotte	North Carolina	United States	28204
29	East Carolina University Brody School of Medicine /ID# 227192	Greenville	North Carolina	United States	27834
30	Novant Health Forsyth Medical Center /ID# 228340	Winston-Salem	North Carolina	United States	27103
31	Gabrail Cancer Center Research /ID# 227204	Canton	Ohio	United States	44718
32	The Christ Hospital /ID# 229335	Cincinnati	Ohio	United States	45219
33	Fox Chase Cancer Center /ID# 231484	Philadelphia	Pennsylvania	United States	19111
34	Lankenau Medical Center /ID# 228921	Wynnewood	Pennsylvania	United States	19096
35	Medical University of South Carolina /ID# 227351	Charleston	South Carolina	United States	29425
36	Gibbs Cancer Center & Research /ID# 229373	Spartanburg	South Carolina	United States	29303-3040
37	Thompson Cancer Survival Ctr /ID# 228295	Knoxville	Tennessee	United States	37916
38	Baylor Scott & White Medical Center- Temple /ID# 227185	Temple	Texas	United States	76508-0001
39	Virginia Commonwealth University Medical Center Main Hospital /ID# 227211	Richmond	Virginia	United States	23219
40	UW, Cancer Ctr ProHealth Care /ID# 228746	Waukesha	Wisconsin	United States	53188
41	Instituto FIDES /ID# 231500	La Plata	Buenos Aires	Argentina	1900
42	Hospital Universitario Austral /ID# 230865	Pilar	Buenos Aires	Argentina	1629
43	Hospital Italiano de Buenos Aires /ID# 229699	Ciudad Autonoma Buenos Aires	Ciuadad Autonoma De Buenos Aires	Argentina	1199
44	Fundaleu /Id# 229700	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires	Argentina	1114
45	Hospital Aleman /ID# 229698	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires	Argentina	1118
46	Cemic /Id# 229697	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires	Argentina	1431
47	Hospital Privado Univesitario /ID# 229701	Cordoba		Argentina	5016
48	Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 232124	Santa Fe		Argentina	3000
49	Royal Prince Alfred Hospital /ID# 239272	Camperdown	New South Wales	Australia	2050
50	Nepean Hospital /ID# 239093	Kingswood	New South Wales	Australia	2747
51	Townsville University Hospital /ID# 231124	Douglas	Queensland	Australia	4814
52	Royal Hobart Hospital /ID# 228496	Hobart	Tasmania	Australia	7000
53	Peninsula Private /ID# 238796	Langwarrin	Victoria	Australia	3910
54	Fiona Stanley Hospital /ID# 231122	Murdoch	Western Australia	Australia	6150
55	Royal Perth Hospital /ID# 230456	Perth	Western Australia	Australia	6000
56	Universitaetsklinikum St. Poelten /ID# 234015	Sankt Poelten	Niederoesterreich	Austria	3100
57	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228366	Salzburg		Austria	5020
58	Uza /Id# 228521	Edegem	Antwerpen	Belgium	2650
59	Pôle Hospitalier Jolimont /ID# 228520	La Louvière		Belgium	7100
60	Groupe Sante CHC - Clinique du MontLegia /ID# 230415	Liege		Belgium	4000
61	AZ Nikolaas /ID# 228525	Sint-Niklaas		Belgium	9100
62	AZ Turnhout - Campus Sint-Elisabeth /ID# 231628	Turnhout		Belgium	2300
63	Hospital de Clinicas da Universidade Federal do Paraná /ID# 228123	Curitiba	Parana	Brazil	80060-900
64	Hospital Amaral Carvalho /ID# 228129	Jaú	Sao Paulo	Brazil	17210-070
65	Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 228130	São Paulo	Sao Paulo	Brazil	01509-900
66	Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 228706	Rio de Janeiro		Brazil	20231-050
67	Real e Benemérita Associação Portuguesa de Beneficência /ID# 228121	Sao Paulo		Brazil	01323-001
68	Instituto de Assistencia Medica ao Servidor Publico Estadual /ID# 230182	Sao Paulo		Brazil	04039-901
69	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 228127	Sao Paulo		Brazil	05403-000
70	BC Cancer - Vancouver /ID# 228850	Vancouver	British Columbia	Canada	V5Z 1L3
71	Saint John Regional Hospital /ID# 233548	Saint John	New Brunswick	Canada	E2L 4L2
72	Princess Margaret Cancer Centre /ID# 238413	Toronto	Ontario	Canada	M5G 2M9
73	CISSS de la Monteregie /ID# 238412	Greenfield Park	Quebec	Canada	J4V 2H1
74	CHUQ- Hôpital de l'Enfant-Jesus /ID# 231537	Quebec City	Quebec	Canada	G1J 1Z4
75	CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229896	Quebec City	Quebec	Canada	G6V 3Z1
76	CISSSBSL -Hopital regional de Rimouski /ID# 229894	Rimouski	Quebec	Canada	G5L 5T1
77	Peking University Third Hospital /ID# 230885	Beijing	Beijing	China	100191
78	Fujian Medical University Union Hospital /ID# 233919	Fuzhou	Fujian	China	350001
79	Sun Yat-Sen University Cancer Center /ID# 231463	Guangzhou	Guangdong	China	510060
80	Guangdong Provincial People's Hospital /ID# 232512	Guangzhou	Guangdong	China	510080
81	Nanfang Hospital of Southern Medical University /ID# 230383	Guangzhou	Guangdong	China	510515
82	The Fourth Hospital of Hebei Medical University /ID# 238657	Shijiazhuang	Hebei	China	050011
83	Henan Cancer Hospital /ID# 230459	Zhengzhou	Henan	China	450008
84	Hubei Cancer Hospital /ID# 232255	Wuhan	Hubei	China	430079
85	Hunan Cancer Hospital /ID# 232153	Changsha	Hunan	China	410006
86	Jiangsu Cancer Hospital /ID# 232470	Nanjing	Jiangsu	China	210009
87	The First Affiliated Hospital of Soochow University /ID# 232511	Suzhou	Jiangsu	China	215006
88	The Affiliated Hospital of Xuzhou Medical University /ID# 232513	Xuzhou	Jiangsu	China	221000
89	The First Affiliated Hospital of Nanchang University /ID# 231047	Nanchang	Jiangxi	China	330006
90	The First Hospital of China Medical University /ID# 232509	Shenyang	Liaoning	China	110001
91	Xijing Hospital /ID# 238650	Xian	Shanxi	China	710032
92	The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 238893	Urumqi	Xinjiang	China	830000
93	Yunnan Cancer Hospital /ID# 232062	Kunming	Yunnan	China	650118
94	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230390	Hangzhou	Zhejiang	China	310006
95	Zhejiang Cancer hospital /ID# 231389	Hangzhou	Zhejiang	China	310022
96	Jiangxi Cancer Hospital /ID# 232507	Nanchang		China	330029
97	Tianjin Medical University Cancer Institute and Hospital /ID# 230876	Tianjin		China	300060
98	Fakultni Nemocnice Brno /ID# 228271	Brno		Czechia	625 00
99	Fakultni nemocnice Hradec Kralove /ID# 228269	Hradec Kralove		Czechia	500 05
100	Fakultni nemocnice Kralovske Vinohrady /ID# 228564	Praha		Czechia	100 34
101	Vseobecna fakultni nemocnice v Praze /ID# 228565	Praha		Czechia	128 08
102	Fakultni Nemocnice v Motole /ID# 228272	Praha		Czechia	150 06
103	Aarhus University Hospital /ID# 229740	Aarhus N	Midtjylland	Denmark	8200
104	Sygehus Lillebælt, Vejle /ID# 227404	Vejle	Syddanmark	Denmark	7100
105	Regionshospitalet Godstrup /ID# 227466	Herning		Denmark	7400
106	CHU Clermont-Ferrand /ID# 238676	Clermont	Auvergne-Rhone-Alpes	France	63100
107	HCL - Hôpital Lyon Sud /ID# 231449	Pierre Benite CEDEX	Auvergne-Rhone-Alpes	France	69495
108	CHU de Rennes - PONTCHAILLOU /ID# 230356	Rennes	Bretagne	France	35000
109	CHU Dijon /ID# 230354	Dijon	Cote-d Or	France	21000
110	CHU Limoges - Dupuytren 1 /ID# 231450	Limoges CEDEX 1	Franche-Comte	France	87042
111	CHU NIMES - Hopital Caremeau /ID# 230351	Nimes CEDEX 9	Gard	France	30029
112	CHU Bordeaux - Hopital Haut Leveque /ID# 230347	Pessac CEDEX	Gironde	France	33604
113	CHRU Lille - Hopital Claude Huriez /ID# 230353	Lille	Hauts-de-France	France	59037
114	CHRU Nancy - Hôpitaux de Brabois /ID# 241595	Vandœuvre-lès-Nancy	Meurthe-et-Moselle	France	54500
115	CHU de Nantes, Hotel Dieu -HME /ID# 245928	Nantes	Pays-de-la-Loire	France	44000
116	CHU Poitiers - La milétrie /ID# 230357	Poitiers	Poitou-Charentes	France	86000
117	Centre Leon Berard /ID# 230348	Lyon CEDEX 08	Rhone	France	69373
118	Hopital Henri Mondor /ID# 230358	Creteil		France	94000
119	CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 234095	La Roche Sur Yon		France	85000
120	AP-HP - Hopital Saint-Louis /ID# 232067	Paris		France	75010
121	Hopital Pitie Salpetriere /ID# 230360	Paris		France	75013
122	IUCT Oncopole /ID# 233486	Toulouse Cedex 9		France	31059
123	Universitaetsklinikum Tuebingen /ID# 229663	Tubingen	Baden-Wuerttemberg	Germany	72076
124	Universitaetsklinikum Giessen /ID# 234245	Gießen	Hessen	Germany	35392
125	Universitaetsklinikum Leipzig /ID# 242907	Leipzig	Sachsen	Germany	04103
126	Universitaetsklinikum Jena /ID# 232064	Jena	Thueringen	Germany	07747
127	Sozialstiftung Bamberg /ID# 229184	Bamberg		Germany	96049
128	Helios Klinikum Berlin-Buch /ID# 229178	Berlin		Germany	13125
129	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 229754	Dresden		Germany	01307
130	Universitaetsklinikum Essen /ID# 229180	Essen		Germany	45147
131	SRH Wald-Klinikum Gera /ID# 232117	Gera		Germany	07548
132	Universitaetsmedizin Goettingen /ID# 230411	Goettingen		Germany	37075
133	Klinikum Kassel /ID# 229185	Kassel		Germany	34125
134	Otto-von-Guericke-Universitaet /ID# 230144	Magdeburg		Germany	39120
135	Klinikum Mutterhaus der Borromäerinnen /ID# 232354	Trier		Germany	54290
136	Universitaetsklinikum Wuerzburg /ID# 229278	Wuerzburg		Germany	97080
137	General Hospital of Athens Laiko /ID# 226626	Athens	Attiki	Greece	11527
138	Alexandra General Hospital /ID# 226632	Athens	Attiki	Greece	11528
139	University General Hospital Attikon /ID# 226629	Athens	Attiki	Greece	12462
140	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 226633	Athens		Greece	10676
141	University General Hospital of Ioannina /ID# 226628	Ioannina		Greece	45500
142	General University Hospital of Thessaloniki AXEPA /ID# 226630	Thessaloniki		Greece	54636
143	Theageneio Anticancer Hospital /ID# 226627	Thessaloniki		Greece	54639
144	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 229289	Szeged	Csongrad	Hungary	6725
145	Debreceni Egyetem Klinikai Kozpont /ID# 229287	Debrecen	Hajdu-Bihar	Hungary	4032
146	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 232203	Nyíregyháza	Nyiregyhaza	Hungary	4400
147	Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 246475	Kaposvár	Somogy	Hungary	7400
148	Markusovszky Egyetemi Oktatokorhaz /ID# 229290	Szombathely	Vas	Hungary	9700
149	Semmelweis Egyetem /ID# 229291	Budapest		Hungary	1085
150	Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 229286	Budapest		Hungary	1097
151	Orszagos Onkologiai Intezet /ID# 229292	Budapest		Hungary	1122
152	The Chaim Sheba Medical Center /ID# 228322	Ramat Gan	Tel-Aviv	Israel	5265601
153	Tel Aviv Sourasky Medical Center /ID# 228529	Tel Aviv-Yafo	Tel-Aviv	Israel	6423906
154	Assaf Harofeh Medical Center /ID# 228037	Be'Er Ya'Akov		Israel	70300
155	Rambam Health Care Campus /ID# 227849	Haifa		Israel	3109601
156	Hadassah /ID# 227846	Jerusalem		Israel	91120
157	Rabin Medical Center /ID# 228043	Petakh Tikva		Israel	4941492
158	Ziv Medical Center /ID# 232257	Safed		Israel	13100
159	Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 228458	San Giovanni Rotondo	Foggia	Italy	71013
160	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 230402	Rome	Lazio	Italy	00168
161	Ospedale San Raffaele IRCCS /ID# 228669	Milan	Lombardia	Italy	20132
162	IEO -Istituto Europeo di Oncologia /ID# 227396	Milan	Milano	Italy	20141
163	Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino /ID# 229820	Torino	Piemonte	Italy	10126
164	Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 229602	Candiolo	Torino	Italy	10060
165	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 227401	Alessandria		Italy	15121
166	Centro di Riferimento Oncologico /ID# 227395	Aviano		Italy	33081
167	I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 227400	Bari		Italy	70124
168	ASST Spedali civili di Brescia /ID# 227397	Brescia		Italy	25123
169	Azienda Ospedaliera Universitaria Federico II /ID# 230403	Napoli		Italy	80131
170	Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 227399	Novara		Italy	28100
171	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 227402	Palermo		Italy	90146
172	Ospedale Santa Maria Croci /ID# 227394	Ravenna		Italy	48121
173	NHO Nagoya Medical Center /ID# 230678	Nagoya-shi	Aichi	Japan	460-0001
174	Aichi Cancer Center Hospital /ID# 230134	Nagoya-shi	Aichi	Japan	464-8681
175	National Cancer Center Hospital East /ID# 232423	Kashiwa-shi	Chiba	Japan	277-8577
176	Kyushu University Hospital /ID# 230136	Fukuoka-shi	Fukuoka	Japan	812-8582
177	Hokkaido University Hospital /ID# 231443	Sapporo-shi	Hokkaido	Japan	060-8648
178	Kagoshima University Hospital /ID# 232251	Kagoshima-shi	Kagoshima	Japan	890-8520
179	Kyoto University Hospital /ID# 231156	Kyoto-shi	Kyoto	Japan	606-8507
180	Tohoku University Hospital /ID# 232303	Sendai-shi	Miyagi	Japan	9808574
181	Okayama University Hospital /ID# 232009	Okayama-shi	Okayama	Japan	700-8558
182	Kindai University Hospital /ID# 232152	Osakasayama-shi	Osaka	Japan	589-8511
183	National Cancer Center Hospital /ID# 230004	Chuo-ku	Tokyo	Japan	104-0045
184	Yamagata University Hospital /ID# 230005	Yamagata-shi	Yamagata	Japan	990-9585
185	Seoul National University Bundang Hospital /ID# 228448	Seongnam	Gyeonggido	Korea, Republic of	13620
186	Inje University Busan Paik Hospital /ID# 230293	Busan		Korea, Republic of	47392
187	Dong-A University Hospital /ID# 228638	Busan		Korea, Republic of	49201
188	Pusan National University Hospital /ID# 229798	Busan		Korea, Republic of	49241
189	Keimyung University Dongsan Medical Center /ID# 229800	Daegu		Korea, Republic of	41931
190	Jeonbuk National University Hospital /ID# 228908	Jeonju		Korea, Republic of	54907
191	Seoul National University Hospital /ID# 228446	Seoul		Korea, Republic of	03080
192	Asan Medical Center /ID# 228444	Seoul		Korea, Republic of	05505
193	Samsung Medical Center /ID# 228445	Seoul		Korea, Republic of	06351
194	The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 228447	Seoul		Korea, Republic of	06591
195	Amphia Ziekenhuis /ID# 247739	Breda		Netherlands	4818 CK
196	Middlemore Clinical Trials /ID# 228509	Papatoetoe	Auckland	New Zealand	2025
197	North Shore Hospital /ID# 228508	Takapuna	Auckland	New Zealand	0622
198	Palmerston North Hospital /ID# 232352	Palmerston North	Manawatu-Wanganui	New Zealand	4442
199	Wellington Regional Hospital /ID# 234104	Newtown	Wellington	New Zealand	6021
200	Pratia MCM Krakow /ID# 229121	Krakow	Malopolskie	Poland	30-510
201	Szpitale Pomorskie Sp. z o.o /ID# 229122	Gdynia	Pomorskie	Poland	81-519
202	Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 229362	Kielce	Swietokrzyskie	Poland	25-734
203	ARS-MEDICAL Sp. z o.o. /ID# 229601	Pila	Wielkopolskie	Poland	64-920
204	Pratia SA /ID# 229299	Skorzewo	Wielkopolskie	Poland	60-185
205	Hematology and Oncology Institute /ID# 230056	Manati		Puerto Rico	00674
206	Pan American Center for Oncology Trials, LLC /ID# 230055	Rio Piedras		Puerto Rico	00935
207	Republican Oncological Clinical Dispensary /ID# 230432	Kazan	Tatarstan, Respublika	Russian Federation	420029
208	Narodny Onkologicky ustav /ID# 239510	Bratislava		Slovakia	831 01
209	Univerzitna nemocnica L. Pasteura Kosice /ID# 240175	Kosice		Slovakia	040 01
210	Univerzitna nemocnica Martin /ID# 240827	Martin		Slovakia	036 01
211	Wits Clinical Research Site /ID# 228895	Johannesburg	Gauteng	South Africa	2193
212	Albert Alberts Stem Cell Transplant Centre /ID# 228896	Pretoria	Gauteng	South Africa	0044
213	University of Cape Town /ID# 228900	Cape Town	Western Cape	South Africa	7925
214	Haemalife Inc. Netcare Kuilsrivier Hospital /ID# 243392	Kuilsrivier	Western Cape	South Africa	7580
215	Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108	Badalona	Barcelona	Spain	08916
216	Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 228107	Hospitalet de Llobregat	Barcelona	Spain	08908
217	Hospital Unversitario Marques de Valdecilla /ID# 228984	Santander	Cantabria	Spain	39008
218	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 228116	Pamplona	Navarra	Spain	31008
219	Hospital Parc de Salut del Mar /ID# 228106	Barcelona		Spain	08003
220	Hospital Santa Creu i Sant Pau /ID# 229859	Barcelona		Spain	08041
221	Hospital Universitario Reina Sofia /ID# 228122	Cordoba		Spain	14004
222	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 229157	Madrid		Spain	28027
223	MD Anderson Madrid /ID# 229860	Madrid		Spain	28033
224	Hospital Universitario Ramon y Cajal /ID# 228113	Madrid		Spain	28034
225	Hospital Universitario Fundacion Jimenez Diaz /ID# 228110	Madrid		Spain	28040
226	Hospital Universitario 12 de Octubre /ID# 228109	Madrid		Spain	28041
227	Hospital Universitario La Paz /ID# 228111	Madrid		Spain	28046
228	Hospital Universitario de Salamanca /ID# 228117	Salamanca		Spain	37711
229	Hospital Universitario Virgen del Rocio /ID# 228118	Sevilla		Spain	41013
230	Hallands Hospital Halmstad /ID# 229868	Halmstad	Hallands Lan	Sweden	302 33
231	Sunderby sjukhus /ID# 228165	Lulea	Norrbottens Lan	Sweden	971 80
232	Sodra Alvsborgs sjukhus /ID# 228886	Boras	Vastra Gotalands Lan	Sweden	501 82
233	Sahlgrenska University Hospital /ID# 229658	Gothenburg	Vastra Gotalands Lan	Sweden	413 45
234	Linkoping University Hospital /ID# 233520	Linkoping		Sweden	581 85
235	Kantonsspital Aarau AG /ID# 229113	Aarau	Aargau	Switzerland	5001
236	Kantonsspital St. Gallen /ID# 229117	St. Gallen	Sankt Gallen	Switzerland	9007
237	EOC Ospedale Regionale di Bellinzona e Valli /ID# 228922	Bellinzona	Ticino	Switzerland	6500
238	Universitätsspital Zürich /ID# 228920	Zürich	Zuerich	Switzerland	8091
239	Kaohsiung Chang Gung Memorial Hospital /ID# 227384	Kaohsiung		Taiwan	833
240	China Medical University Hospital /ID# 227379	Taichung City		Taiwan	40447
241	Taichung Veterans General Hospital /ID# 227383	Taichung		Taiwan	40705
242	National Cheng Kung University Hospital /ID# 227381	Tainan		Taiwan	704
243	Taipei Veterans General Hosp /ID# 227380	Taipei City		Taiwan	11217
244	Ankara Universitesi Fakultesi /ID# 227790	Ankara		Turkey	06620
245	Akdeniz Universitesi Tip Fakul /ID# 227791	Antalya		Turkey	07059
246	Dicle Universitesi Tip /ID# 230087	Diyarbakir		Turkey	21200
247	Istanbul Florence Nightingale Hastanesi /ID# 229546	Istanbul		Turkey	34200
248	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 227855	Istanbul		Turkey	34899
249	Ege University Medical Faculty /ID# 227792	Izmir		Turkey	35040
250	Kocaeli University Med Faculty /ID# 227854	Kocaeli		Turkey	41380
251	Ondokuz mayis University Facul /ID# 227794	Samsun		Turkey	55200
252	Communal non-profit enterprise Regional Center of Oncology /ID# 226976	Kharkiv		Ukraine	61070
253	National Cancer Institute /ID# 230221	Kyiv		Ukraine	03022
254	University Hospital of Derby and Burton NHS Foundation Trust /ID# 234093	Derby	Derbyshire	United Kingdom	DE22 3NE
255	Barts Health NHS Trust /ID# 230028	London	London, City Of	United Kingdom	E1 2ES
256	Oxford University Hospitals NHS Foundation Trust /ID# 230035	Oxford	Oxfordshire	United Kingdom	OX3 9DU
257	NHS Greater Glasgow and Clyde /ID# 230027	Glasgow	Scotland	United Kingdom	G12 0XH
258	University Hospitals of North Midlands NHS Trust /ID# 230042	Stoke-on-Trent	Staffordshire	United Kingdom	ST4 6QG
259	University Hospitals Birmingham NHS Foundation Trust /ID# 230043	Birmingham		United Kingdom	B15 2TH
260	East Kent Hospitals University NHS Foundation Trust /ID# 230152	Canterbury		United Kingdom	CT1 3NG
261	East Suffolk and North Essex NHS Foundation Trust /ID# 230040	Colchester		United Kingdom	CO4 5JL
262	Leeds Teaching Hospitals NHS Trust /ID# 230471	Leeds		United Kingdom	LS9 7TF
263	The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 230036	Liverpool		United Kingdom	L7 8YA
264	The Christie Hospital /ID# 230124	Manchester		United Kingdom	M20 4BX
265	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 230123	Newcastle Upon Tyne		United Kingdom	NE7 7DN
266	University Hospital Plymouth NHS Trust /ID# 230038	Plymouth		United Kingdom	PL6 5FP
267	Portsmouth Hospitals University NHS Trust /ID# 230044	Portsmouth		United Kingdom	PO6 3LY
268	South Tyneside and Sunderland NHS Foundation Trust /ID# 230039	South Shields		United Kingdom	NE34 0PL