VIALE-M: A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04102020

Collaborator

Roche-Genentech (Industry)

482

Enrollment

242

Locations

Arms

90.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be conducted in 2 phases - Dose Finding portion to determine RPTD of venetoclax in combination with CC-486 and Randomization portion to evaluate if venetoclax in combination with CC-486 as maintenance therapy improves relapse-free survival (RFS) compared to CC-486.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Drug: Venetoclax Drug: Azacitidine Drug: Placebo for Venetoclax Drug: CC-486	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

482 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Double-Blind, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)

Actual Study Start Date :

Mar 26, 2020

Anticipated Primary Completion Date :

Nov 12, 2026

Anticipated Study Completion Date :

Oct 19, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Dose Confirmation Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.	Drug: Venetoclax Tablet: Oral Other Names: ABT-199 GDC-0199 Venclexta Drug: Azacitidine Subcutaneous (SC) or intravenous (IV) injection
Experimental: Part 3 (Dose Finding): Dose Escalation Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).	Drug: Venetoclax Tablet: Oral Other Names: ABT-199 GDC-0199 Venclexta Drug: CC-486 Tablet; Oral Other Names: Azacitidine
Experimental: Part 3 (Dose Finding): Safety Expansion Participants will receive venetoclax QD for up to 24 cycles, CC-486 QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.	Drug: Venetoclax Tablet: Oral Other Names: ABT-199 GDC-0199 Venclexta Drug: CC-486 Tablet; Oral Other Names: Azacitidine
Experimental: Part 3 (Randomization): Venetoclax + CC-486 Participants will receive venetoclax QD, CC-486 QD on Days 1-14 of each 28-day cycle for 24 cycles.	Drug: Venetoclax Tablet: Oral Other Names: ABT-199 GDC-0199 Venclexta Drug: CC-486 Tablet; Oral Other Names: Azacitidine
Experimental: Part 3 (Randomization): Placebo + CC-486 Participants will receive Placebo for venetoclax QD, CC-486 QD on Days 1-14 of each 28-day cycle for 24 cycles.	Drug: Placebo for Venetoclax Tablet; Oral Drug: CC-486 Tablet; Oral Other Names: Azacitidine

Outcome Measures

Primary Outcome Measures

Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1) [Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months]
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion) [Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months]
DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with CC-486 as described in the protocol and evaluated by the Investigator and the sponsor.
Relapse-Free Survival (RFS) (Part 3 Randomization Portion) [Time from treatment to relapse or death from any cause, up to approximately 3 years]
RFS is defined as the number of days from randomization to the date of relapse or the date of death from any cause, whichever comes first.

Secondary Outcome Measures

Overall Survival (OS) (Part 3 Randomization Portion) [Time from treatment to death from any cause, up to approximately 3 years]
OS is defined as the number of days from the date of randomization to the date of death.
Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) (Part 3 Randomization Portion) [Measured From Baseline to approximately 3.5 years after the first participant is randomized]
The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.
Time to Deterioration in Global Health Status (GHS)/Quality-of Life (QoL) Score Based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30-Item (EORTC QLQ-C30) Scoring Manual (Part 3 Randomization Portion) [Measured From Baseline to approximately 3.5 years after the first participant is randomized]
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Change From Baseline in Patient Reported Outcomes (PRO) Fatigue Score Based on Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a (Part 3 Randomization Portion) [Measured From Baseline to approximately 3.5 years after the first participant is randomized]
Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".
Change From Baseline in Patient Reported Outcomes (PRO) in Items from EORTC QLQ-C30 between Arms A and B (Part 3 Randomization Portion) [Measured From Baseline to approximately 3.5 years after the first participant is randomized]
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social) , symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Change From Baseline in Patient Reported Outcomes (PRO) in Items from European Quality-of-Life-5 Dimesional-5-Level (EQ5D5L) Between Arms A and B (Part 3 Randomization Portion) [Measured From Baseline to approximately 3.5 years after the first participant is randomized]
The EQ5D5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of newly diagnosed acute myeloid leukemia (AML).
Participant meets the following disease activity criteria:
Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
Achieved first CR + CRi within 120days of first dose of study drug or be no more than 75 days since last dose of intensive conventional chemotherapies.
AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

History of acute promyelocytic leukemia (APL).
History of active central nervous system involvement with acute myeloid leukemia (AML).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mitchell Cancer Institute /ID# 216443	Mobile	Alabama	United States	36604
2	Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156	Fountain Valley	California	United States	92708-7501
3	University of California, Los Angeles /ID# 219149	Los Angeles	California	United States	90095
4	Colorado Blood Cancer Institute /ID# 214280	Denver	Colorado	United States	80218
5	Baptist MD Anderson Cancer Center - Jacksonville /ID# 239360	Jacksonville	Florida	United States	32207-8432
6	St. Alphonsus Regional Medical /ID# 216424	Boise	Idaho	United States	83706
7	Rush University Medical Center /ID# 218815	Chicago	Illinois	United States	60612
8	NorthShore University HealthSystem Research Institute /ID# 240029	Evanston	Illinois	United States	60201-3137
9	Indiana Univ School Medicine /ID# 216447	Indianapolis	Indiana	United States	46202
10	University of Kentucky Markey Cancer Center /ID# 215048	Lexington	Kentucky	United States	40536-7001
11	Norton Cancer Institute /ID# 216401	Louisville	Kentucky	United States	40202-3700
12	Tulane Medical Center - New Orleans /ID# 218166	New Orleans	Louisiana	United States	70112-2600
13	Ochsner Clinic Foundation-New Orleans /ID# 214583	New Orleans	Louisiana	United States	70121
14	Tufts Medical Center /ID# 216110	Boston	Massachusetts	United States	02111-1552
15	Massachusetts General Hospital /ID# 217307	Boston	Massachusetts	United States	02114
16	UMass Chan Medical School /ID# 218163	Worcester	Massachusetts	United States	01655
17	University of Mississippi Medical Center /ID# 216475	Jackson	Mississippi	United States	39216-4500
18	Saint Louis University Cancer Center /ID# 218164	Saint Louis	Missouri	United States	63110-2539
19	Oncology Hematology Associates (OHA) - Springfield /ID# 216351	Springfield	Missouri	United States	65807-5287
20	The John Theurer Cancer /ID# 215191	Hackensack	New Jersey	United States	07601
21	Atlantic Health System /ID# 239323	Morristown	New Jersey	United States	07960-6136
22	Rutgers Cancer Institute of New Jersey /ID# 239708	New Brunswick	New Jersey	United States	08901
23	Weill Cornell Medical College /ID# 214847	New York	New York	United States	10065
24	Cleveland Clinic Main Campus /ID# 239339	Cleveland	Ohio	United States	44195
25	The Ohio State University - The James /ID# 215612	Columbus	Ohio	United States	43210-1240
26	Providence Portland Medical Ct /ID# 216231	Portland	Oregon	United States	97213-2933
27	Fox Chase Cancer Center /ID# 239372	Philadelphia	Pennsylvania	United States	19111
28	UPMC Hillman Cancer Ctr /ID# 214051	Pittsburgh	Pennsylvania	United States	15232
29	Prisma Health Cancer Institute-Faris Road /ID# 216066	Greenville	South Carolina	United States	29605-4255
30	St Francis Cancer Center /ID# 216115	Greenville	South Carolina	United States	29607-5253
31	Gibbs Cancer Center & Research /ID# 216192	Spartanburg	South Carolina	United States	29303-3040
32	Tennessee Oncology-Nashville Centennial /ID# 218757	Nashville	Tennessee	United States	37203-1632
33	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584	Dallas	Texas	United States	75246-2003
34	University of Texas MD Anderson Cancer Center /ID# 225201	Houston	Texas	United States	77030
35	Intermountain Healthcare /ID# 217956	Salt Lake City	Utah	United States	84103
36	St George Hospital /ID# 215416	Kogarah	New South Wales	Australia	2217
37	Liverpool Hospital /ID# 215415	Liverpool	New South Wales	Australia	2170
38	Shoalhaven District Memorial Hospital /ID# 221973	Nowra	New South Wales	Australia	2541
39	Wollongong Hospital /ID# 216071	Wollongong	New South Wales	Australia	2500
40	Gold coast University Hospital /ID# 214650	SouthPort	Queensland	Australia	4215
41	Toowoomba Hospital /ID# 217922	Toowoomba	Queensland	Australia	4350
42	Princess Alexandra Hospital /ID# 238753	Woolloongabba	Queensland	Australia	4102
43	Royal Adelaide Hospital /ID# 238754	Adelaide	South Australia	Australia	5000
44	Box Hill Hospital /ID# 217622	Box Hill	Victoria	Australia	3128
45	Barwon Health /ID# 217921	Geelong	Victoria	Australia	3220
46	Perth Blood Institute Ltd /ID# 217531	Nedlands	Western Australia	Australia	6009
47	Universitaetsklinikum St. Poelten /ID# 239225	Sankt Poelten	Niederoesterreich	Austria	3100
48	Ordensklinikum Linz GmbH Elisabethinen /ID# 239434	Linz	Oberoesterreich	Austria	4010
49	Klinikum Wels-Grieskirchen GmbH /ID# 239195	Wels	Oberoesterreich	Austria	4600
50	Medizinische Universitaet Innsbruck /ID# 245505	Innsbruck	Tirol	Austria	6020
51	Medizinische Universitaet Wien /ID# 240499	Vienna	Wien	Austria	1090
52	Hanusch Krankenhaus /ID# 239445	Wien		Austria	1140
53	Hospital São Rafael /ID# 215233	Salvador	Bahia	Brazil	41253-190
54	Hospital de Clinicas de Porto Alegre /ID# 215044	Porto Alegre	Rio Grande Do Sul	Brazil	90035-903
55	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215234	Sao Jose Do Rio Preto	Sao Paulo	Brazil	15090-000
56	Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 215171	Rio de Janeiro		Brazil	20231-050
57	Tom Baker Cancer Centre /ID# 214625	Calgary	Alberta	Canada	T2N 4N2
58	University of Alberta Hospital - Division of Hematology /ID# 215656	Edmonton	Alberta	Canada	T6G 2B7
59	QEII - Health Sciences Centre /ID# 239456	Halifax	Nova Scotia	Canada	B3H 2Y9
60	Juravinski Cancer Centre /ID# 214623	Hamilton	Ontario	Canada	L8V 1C3
61	London Health Sciences Center /ID# 216055	London	Ontario	Canada	N6A 5W9
62	Ottawa Hospital Research Institute /ID# 214627	Ottawa	Ontario	Canada	K1H 8L6
63	Princess Margaret Cancer Centre /ID# 214624	Toronto	Ontario	Canada	M5G 2M9
64	McGill University Health Center Research Institute /ID# 215984	Montreal	Quebec	Canada	H4A 3J1
65	Peking University People's Hospital /ID# 216331	Beijing	Beijing	China	100044
66	Peking Union Medical College Hospital /ID# 216454	Beijing	Beijing	China	100730
67	Chinese PLA General Hospital /ID# 216286	Beijing	Beijing	China	100853
68	Fujian Medical University Union Hospital /ID# 215561	Fuzhou	Fujian	China	350001
69	Guangdong Provincial People's Hospital /ID# 216284	Guangzhou	Guangdong	China	510080
70	Nanfang Hospital of Southern Medical University /ID# 215565	Guangzhou	Guangdong	China	510515
71	Henan Cancer Hospital /ID# 215566	Zhengzhou	Henan	China	450008
72	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046	Wuhan	Hubei	China	430022
73	The First Hospital of Jilin University /ID# 215560	Changchun	Jilin	China	130021
74	The First Hospital of China Medical University /ID# 216285	Shenyang	Liaoning	China	110001
75	Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283	Xi'an	Shaanxi	China	710038
76	Shanghai Tongji Hospital /ID# 218800	Shanghai	Shanghai	China	200065
77	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558	Tianjin	Tianjin	China	300020
78	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564	Hangzhou	Zhejiang	China	310006
79	Beijing Friendship Hospital /ID# 216455	Beijing		China	100032
80	Peking University International Hospital /ID# 217439	Beijing		China	102206
81	West China Hospital, Sichuan University /ID# 216606	Chengdu		China	610041
82	Tongji Hospital Tongji Medical College of HUST /ID# 216456	Wuhan		China	430030
83	Fakultni Nemocnice Brno /ID# 214807	Brno		Czechia	625 00
84	Fakultni nemocnice Hradec Kralove /ID# 246168	Hradec Kralove		Czechia	500 05
85	Fakultni nemocnice Ostrava /ID# 214809	Ostrava		Czechia	708 52
86	Ustav hematologie a krevni transfuze /ID# 215137	Praha		Czechia	128 00
87	CHU de Nice - Hôpital Archet 1 /ID# 217368	Nice	Alpes-Maritimes	France	06200
88	HCL - Hôpital Lyon Sud /ID# 239904	Pierre Benite CEDEX	Auvergne-Rhone-Alpes	France	69495
89	CHU de Rennes - PONTCHAILLOU /ID# 239906	Rennes	Bretagne	France	35000
90	CHU Bordeaux - Hopital Haut Leveque /ID# 215150	Pessac	Gironde	France	33604
91	CHRU Lille - Hopital Claude Huriez /ID# 217474	Lille	Hauts-de-France	France	59037
92	CHU Montpellier - Hôpital Saint Eloi /ID# 239907	Montpellier Cedex 5	Herault	France	34295
93	Hopital Avicenne - APHP /ID# 215152	Bobigny	Ile-de-France	France	93000
94	CHRU Tours - Hopital Bretonneau /ID# 216186	Tours CEDEX 9	Indre-et-Loire	France	37044
95	CHRU Nancy - Hôpitaux de Brabois /ID# 239903	Vandœuvre-lès-Nancy	Meurthe-et-Moselle	France	54500
96	CHU de Nantes, Hotel Dieu -HME /ID# 217367	Nantes	Pays-de-la-Loire	France	44000
97	Centre Hospitalier de la Cote Basque /ID# 216185	Bayonne	Pyrenees-Atlantiques	France	64100
98	Centre Hospitalier du Mans /ID# 215148	Le Mans CEDEX 9	Sarthe	France	72037
99	Institut Gustave Roussy /ID# 215158	Villejuif Cedex	Val-de-Marne	France	94805
100	Chu Angers /Id# 215151	Angers		France	49933
101	Hopital Henri Mondor /ID# 215159	Creteil		France	94000
102	Centre Hospitalier de Versailles André Mignot /ID# 215157	Le Chesnay		France	78150
103	IUCT Oncopole /ID# 239905	Toulouse Cedex 9		France	31059
104	Universitatsklinikum Mannheim /ID# 239762	Mannheim	Baden-Wuerttemberg	Germany	68167
105	Universitaetsklinikum Koeln /ID# 239763	Köln	Nordrhein-Westfalen	Germany	50937
106	Universitaetsklinikum Leipzig /ID# 214440	Leipzig	Sachsen	Germany	04103
107	Universitaetsklinikum Jena /ID# 239766	Jena	Thueringen	Germany	07747
108	Klinikum Chemnitz gGmbH /ID# 216073	Chemnitz		Germany	09116
109	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 240983	Dresden		Germany	01307
110	Universitaetsklinikum Essen /ID# 239764	Essen		Germany	45147
111	Universitaetsklinikum Halle (Saale) /ID# 221109	Halle (Saale)		Germany	06120
112	Staedtisches Krankenhaus Kiel /ID# 239761	Kiel		Germany	24116
113	Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173	Luebeck		Germany	23538
114	Universitaetsklinikum Giessen und Marburg /ID# 214734	Marburg		Germany	35043
115	Rotkreuzkliniken Munchen /ID# 239767	Munich		Germany	80634
116	Krankenhaus Barmherzige Brueder Regensburg /ID# 215170	Regensburg		Germany	93049
117	Universitaetsmedizin Rostock /ID# 239765	Rostock		Germany	18057
118	General Hospital of Athens Laiko /ID# 213869	Athens	Attiki	Greece	11527
119	University General Hospital Attikon /ID# 214298	Athens	Attiki	Greece	12462
120	University General Hospital of Heraklion PA.G.N.I /ID# 214075	Heraklion	Kriti	Greece	71500
121	General University Hospital of Alexandroupolis /ID# 213870	Alexandroupolis		Greece	68100
122	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872	Athens		Greece	10676
123	University General Hospital of Patras /ID# 213871	RION Patras Achaia		Greece	26504
124	Debreceni Egyetem Klinikai Kozpont /ID# 214422	Debrecen	Hajdu-Bihar	Hungary	4032
125	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 214425	Nyíregyháza	Nyiregyhaza	Hungary	4400
126	Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 214426	Kaposvár	Somogy	Hungary	7400
127	Markusovszky Egyetemi Oktatokorhaz /ID# 215644	Szombathely	Vas	Hungary	9700
128	Semmelweis Egyetem /ID# 214423	Budapest		Hungary	1085
129	Soroka University Medical Center /ID# 240856	Be'er Sheva	HaDarom	Israel	8443901
130	Tel Aviv Sourasky Medical Center /ID# 239698	Tel Aviv-Yafo	Tel-Aviv	Israel	6423906
131	The Lady Davis Carmel Medical Center /ID# 239706	Haifa		Israel	34362
132	Shaare Zedek Medical Center /ID# 239699	Jerusalem		Israel	91031
133	Hadassah Medical Center-Hebrew University /ID# 239700	Jerusalem		Israel	91120
134	Rabin Medical Center /ID# 239696	Petakh Tikva		Israel	4941492
135	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944	Ancona		Italy	60126
136	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948	Bologna		Italy	40138
137	ASST Spedali civili di Brescia /ID# 214580	Brescia		Italy	25123
138	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802	Catania		Italy	95123
139	Ospedale Policlinico San Martino /ID# 240017	Genova		Italy	16132
140	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 240018	Meldola		Italy	47014
141	ASST Grande Ospedale Metropolitano Niguarda /ID# 213946	Milano		Italy	20162
142	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826	Milan		Italy	20122
143	Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947	Napoli		Italy	80131
144	Azienda Ospedaliera Universitaria Federico II /ID# 214278	Napoli		Italy	80131
145	Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 240016	Reggio Calabria		Italy	89124
146	Ospedale S.Eugenio /ID# 214277	Rome		Italy	00144
147	Azienda Sanitaria Universitaria Giuliano Isontina /ID# 240010	Trieste		Italy	34128
148	A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505	Turin		Italy	10126
149	ASST Sette Laghi /ID# 240019	Varese		Italy	21100
150	Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680	Nagoya-shi	Aichi	Japan	453-8511
151	Aichi Cancer Center Hospital /ID# 215284	Nagoya-shi	Aichi	Japan	464-8681
152	University of Fukui Hospital /ID# 215283	Yoshida-gun	Fukui	Japan	910-1193
153	National Hospital Organization Kyushu Cancer Center /ID# 214841	Fukuoka-shi	Fukuoka	Japan	811-1395
154	Kyushu University Hospital /ID# 215286	Fukuoka-shi	Fukuoka	Japan	812-8582
155	Hokkaido University Hospital /ID# 215938	Sapporo-shi	Hokkaido	Japan	060-8648
156	National Hospital Organization Mito Medical Center /ID# 214699	Higashi Ibaraki-gun	Ibaraki	Japan	311-3193
157	Tohoku University Hospital /ID# 214669	Sendai-shi	Miyagi	Japan	9808574
158	Nagasaki University Hospital /ID# 214916	Nagasaki-shi	Nagasaki	Japan	852-8501
159	Okayama University Hospital /ID# 214840	Okayama-shi	Okayama	Japan	700-8558
160	Osaka Metropolitan University Hospital /ID# 215225	Osaka-shi	Osaka	Japan	545-8586
161	Kindai University Hospital /ID# 214915	Osakasayama-shi	Osaka	Japan	589-8511
162	Saitama Medical University International Medical Center /ID# 214823	Hidaka-shi	Saitama	Japan	350-1298
163	NTT Medical Center Tokyo /ID# 214959	Shinagawa-ku	Tokyo	Japan	141-8625
164	Yamagata University Hospital /ID# 214698	Yamagata-shi	Yamagata	Japan	990-9585
165	Seoul National University Bundang Hospital /ID# 215549	Seongnam	Gyeonggido	Korea, Republic of	13620
166	Pusan National University Hospital /ID# 213941	Busan		Korea, Republic of	49241
167	Seoul National University Hospital /ID# 213943	Seoul		Korea, Republic of	03080
168	Samsung Medical Center /ID# 213940	Seoul		Korea, Republic of	06351
169	Wojewodzki Szpital Specjalistyczny w Legnicy /ID# 245891	Legnica	Dolnoslaskie	Poland	59-220
170	Szpital Wojewodzki w Opolu sp. z o.o. /ID# 241924	Opole	Dolnoslaskie	Poland	45-372
171	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 239481	Bydgoszcz	Kujawsko-pomorskie	Poland	85-168
172	MICS Centrum Medyczne Torun /ID# 241269	Torun	Kujawsko-pomorskie	Poland	87-100
173	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 239484	Lodz	Lodzkie	Poland	93-513
174	SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 244246	Krakow	Malopolskie	Poland	31-501
175	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 239555	Slupsk	Pomorskie	Poland	76-200
176	Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 239483	Poznań		Poland	60-355
177	IPO Lisboa FG, EPE /ID# 240972	Lisboa		Portugal	1099-023
178	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 241131	Lisboa		Portugal	1649-035
179	IPO Porto FG, EPE /ID# 240970	Porto		Portugal	4200-072
180	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241025	Porto		Portugal	4200-319
181	Pan American Center for Oncology Trials, LLC /ID# 214953	Rio Piedras		Puerto Rico	00935
182	Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309	Nizhniy Novgorod	Nizhegorodskaya Oblast	Russian Federation	603126
183	Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393	St. Petersburg	Sankt-Peterburg	Russian Federation	197101
184	Moscow Cancer Research Institute n.a. P. A. Herzen /ID# 214312	Moscow		Russian Federation	125284
185	City Clinical Hospital #40 of the Moscow City Health Department /ID# 215223	Moscow		Russian Federation	129301
186	Clinic of Immunopathology, SRIFCI /ID# 217937	Novosibirsk		Russian Federation	630047
187	Almazov National Medical Research Centre /ID# 214306	Sankt-Peterburg		Russian Federation	197341
188	Regional Clinical Hospital of Yaroslavl /ID# 214318	Yaroslavl		Russian Federation	150062
189	Instituto Catalan de Oncologia (ICO) Badalona /ID# 240152	Badalona	Barcelona	Spain	08916
190	Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715	Hospitalet de Llobregat	Barcelona	Spain	08908
191	Hospital Universitario Dr. Negrin /ID# 239887	Las Palmas de Gran Canaria	Las Palmas	Spain	35019
192	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 238889	Pamplona	Navarra	Spain	31008
193	Hospital Universitario de Navarra /ID# 214788	Pamplona	Navarra	Spain	31008
194	Complejo Hospitalario Universitario Ourense /ID# 214787	Orense	Ourense	Spain	32005
195	Hospital Universitario A Coruna - CHUAC /ID# 238883	A Coruna		Spain	15006
196	Hospital Clinic de Barcelona /ID# 238884	Barcelona		Spain	08036
197	Hospital Santa Creu i Sant Pau /ID# 214714	Barcelona		Spain	08041
198	Hospital Universitario Reina Sofia /ID# 214786	Cordoba		Spain	14004
199	CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 242388	Madrid		Spain	28027
200	Hospital Universitario Infanta Leonor /ID# 214843	Madrid		Spain	28031
201	MD Anderson Madrid /ID# 214477	Madrid		Spain	28033
202	Hospital Universitario Ramon y Cajal /ID# 214684	Madrid		Spain	28034
203	Hospital Universitario Fundacion Jimenez Diaz /ID# 214933	Madrid		Spain	28040
204	Hospital Universitario 12 de Octubre /ID# 214789	Madrid		Spain	28041
205	Hospital Universitario Virgen de la Victoria /ID# 214713	Malaga		Spain	29010
206	Hospital Universitario Virgen del Rocio /ID# 238887	Sevilla		Spain	41013
207	Hospital Universitario y Politecnico La Fe /ID# 245893	Valencia		Spain	46026
208	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953	Kaohsiung		Taiwan	807
209	China Medical University Hospital /ID# 213952	Taichung City		Taiwan	40447
210	National Taiwan University Hospital /ID# 213939	Taipei City		Taiwan	100
211	Linkou Chang Gung Memorial Hospital /ID# 213951	Taoyuan City		Taiwan	333
212	Cukurova Universitesi Tip Fakultesi /ID# 239920	Saricam Adana	Adana	Turkey	01330
213	Erciyes University Medical Fac /ID# 214240	Melikgazi	Kayseri	Turkey	38030
214	Gulhane Askeri Tip Academy /ID# 214242	Ankara		Turkey	06010
215	Hacettepe University Medical Faculty /ID# 239857	Ankara		Turkey	06230
216	Ankara Univ Medical Faculty /ID# 214239	Ankara		Turkey	06590
217	Ankara City Hospital /ID# 239859	Ankara		Turkey	06800
218	Adnan Menderes University /ID# 239856	Aydin		Turkey	09100
219	Osmangazi Universitesi Tip Fak /ID# 239281	Eskisehir		Turkey	26480
220	Gaziantep Universitesi Med /ID# 239855	Gaziantep		Turkey	27310
221	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525	Istanbul		Turkey	34098
222	Bagcilar Medipol Mega Universite Hastanesi /ID# 239280	Istanbul		Turkey	34214
223	Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 239282	Istanbul		Turkey	34722
224	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 244901	Istanbul		Turkey	34899
225	Dokuz Eylul University Medical Faculty /ID# 239276	Izmir		Turkey	35340
226	Ondokuz mayis University Facul /ID# 239858	Samsun		Turkey	55200
227	Karadeniz University /ID# 214241	Trabzon		Turkey	61000
228	University Hospitals Bristol /ID# 215911	Bristol	Bristol, City Of	United Kingdom	BS2 8ED
229	Leicester Royal Infirmary /ID# 215924	Leicester	England	United Kingdom	LE1 5WW
230	Barts Health NHS Trust /ID# 215909	London	London, City Of	United Kingdom	E1 2ES
231	Guys and St Thomas NHS Foundation Trust /ID# 215908	London	London, City Of	United Kingdom	SE1 9RT
232	Cardiff & Vale University Health Board /ID# 215906	Cardiff	Wales	United Kingdom	CF14 4XN
233	Belfast Health and Social Care Trust /ID# 215923	Belfast		United Kingdom	BT9 7AB
234	University Hospitals Birmingham NHS Foundation Trust /ID# 215910	Birmingham		United Kingdom	B15 2TH
235	Leeds Teaching Hospitals NHS Trust /ID# 215922	Leeds		United Kingdom	LS9 7TF
236	The Clatterbridge Cancer Centre NHS Foundation Trust /ID# 239332	Liverpool		United Kingdom	L7 8YA
237	University College London Hospitals NHS Foundation Trust /ID# 215921	London		United Kingdom	NW1 2PG
238	King's College Hospital NHS Foundation Trust /ID# 239326	London		United Kingdom	SE5 9RS
239	Portsmouth Hospitals University NHS Trust /ID# 239324	Portsmouth		United Kingdom	PO6 3LY
240	Duplicate_Royal Marsden Hospital /ID# 215920	Sutton		United Kingdom	SM2 5PT
241	St George's University Hospitals NHS Foundation Trust /ID# 239328	Tooting		United Kingdom	SW17 0QT
242	Torbay and South Devon Nhs Foundation Trust /Id# 239331	Torquay		United Kingdom	TQ2 7AA