Clinical trial NCT04401748: Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
Official title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Myelodysplastic Syndrome (MDS)
Keywords: MDS
Myelodysplastic Syndrome
Venetoclax
Azacitidine
AZA
Venclexta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2020-05-26
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of \< 20% bone marrow blasts per marrow biopsy/aspirate at screening.
* Participants must meet the following disease activity criteria:

  * Overall Revised International Prognostic Scoring System (IPSS-R) score \> 3 (intermediate, high or very high).
  * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2.
  * Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.

Exclusion Criteria:

* Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.
* Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up To 5 Years
Secondary outcomes:
measure: Modified Overall Response (mOR)
timeFrame: Up To 5 Years
measure: Percentage of Participants Achieving Overall Hematological Improvement (HI)
timeFrame: Up to 5 Years
measure: Complete Remission (CR)
timeFrame: Up To 36 Months
measure: Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
timeFrame: Up To 5 Years
measure: Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale
timeFrame: Up To 5 Years
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
timeFrame: Up To 5 Years
measure: Overall Response (OR)
timeFrame: Up To 5 Years
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Duplicate_Providence Medical Foundation /ID# 222633
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 221760
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network Cancer Care /ID# 222702
state: California
city: Whittier
country: United States
facility: PIH Health Whittier Hospital /ID# 222647
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers - Boulder /ID# 223723
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine /ID# 222764
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center & Research Institute /ID# 223731
state: Delaware
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers /ID# 221319
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System /ID# 222703
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North /ID# 221318
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists - Panhandle /ID# 221315
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East /ID# 221317
state: Florida
city: Boise
country: United States
facility: St. Luke's Mountain State Tumor Institute /ID# 220838
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 220843
state: Illinois
city: Chicago
country: United States
facility: Duplicate_Rush University Medical Center /ID# 221007
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hosp /ID# 220844
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care, PC /ID# 220840
state: Illinois
city: Fort Wayne
country: United States
facility: Duplicate_Parkview Cancer Institute /ID# 223620
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas /ID# 222648
state: Kansas
city: Baton Rouge
country: United States
facility: Hematology/Oncology Clinic /ID# 224257
state: Louisiana
city: Covington
country: United States
facility: Pontchartrain Cancer Center - Covington /ID# 221005
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology /ID# 223776
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 225068
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 225069
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 219162
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System /ID# 221365
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers /ID# 220848
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321
state: Minnesota
city: Kansas City
country: United States
facility: MidAmerica Division, Inc. /ID# 221895
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635
state: Nevada
city: East Brunswick
country: United States
facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital /ID# 232337
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology - Albany Cancer Center /ID# 223778
state: New York
city: Buffalo
country: United States
facility: University at Buffalo /ID# 221206
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College /ID# 222898
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital /ID# 224450
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center /ID# 222561
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center /ID# 221004
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. /ID# 223724
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic /ID# 220999
state: Oregon
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center /ID# 223733
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Ctr /ID# 223201
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute /ID# 243461
state: South Dakota
city: Chattanooga
country: United States
facility: Tennessee Oncology - Chattanooga / McCallie /ID# 221311
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 220854
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown /ID# 223729
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas /ID# 223725
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Forth Worth /ID# 223777
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center at Texas Medical Center /ID# 219163
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center /ID# 223728
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center- Temple /ID# 221332
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 223734
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Salt Lake Clinic /ID# 219160
state: Utah
city: Gainesville
country: United States
facility: Virginia Cancer Specialists - Gainesville /ID# 223726
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 221590
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute at Reynolds Crossing /ID# 221002
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System /ID# 221358
state: Washington
city: Blacktown
country: Australia
facility: Duplicate_Blacktown Hospital /ID# 234079
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital /ID# 221810
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital /ID# 234078
state: New South Wales
city: SouthPort
country: Australia
facility: Gold coast University Hospital /ID# 222606
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 221805
state: South Australia
city: Fitzroy Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 221809
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health /ID# 221807
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 221387
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH /ID# 221386
state: Oberoesterreich
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 221446
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 221093
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 219066
state: Bruxelles-Capitale
city: La Louvière
country: Belgium
facility: Hospital La Louviere Site Jolimont - Helora /ID# 218921
state: Hainaut
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064
state: Namur
city: Gent
country: Belgium
facility: UZ Gent /ID# 218767
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 218905
state: Vlaams-Brabant
city: Antwerp
country: Belgium
facility: ZNA Middelheim /ID# 218907
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 218212
city: Fortaleza
country: Brazil
facility: Hospital Universitario Walter Cantidio /ID# 223434
state: Ceara
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto /ID# 223080
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339
city: Surrey
country: Canada
facility: BC Cancer - Surrey /ID# 219098
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 219105
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Ctr /ID# 219103
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center Research Institute /ID# 222519
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200
state: Quebec
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital /ID# 225980
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 221442
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University /ID# 222071
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 224566
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University /ID# 222919
state: Hebei
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province /ID# 225790
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 221447
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 221474
state: Hubei
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 221849
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital /ID# 221342
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 221640
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 225983
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University /ID# 222945
state: Liaoning
city: Xi'an
country: China
facility: Shaanxi Provincial people's Hospital /ID# 225728
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital /ID# 221546
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 221601
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918
state: Zhejiang
city: Beijing
country: China
facility: Peking University International Hospital /ID# 222987
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 226810
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno /ID# 221351
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove /ID# 221163
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 219143
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen /ID# 221162
city: Praha
country: Czechia
facility: Ustav hematologie a krevni transfuze /ID# 221350
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 221229
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet 1 /ID# 220992
state: Alpes-Maritimes
city: Marseille
country: France
facility: Hopital de la Conception /ID# 224882
state: Bouches-du-Rhone
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 220989
state: Gironde
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 220988
state: Isere
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 220991
state: Nord
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 222074
state: Pays-de-la-Loire
city: Avignon CEDEX 9
country: France
facility: CH Henri Duffaut /ID# 225185
state: Vaucluse
city: Paris
country: France
facility: AP-HP - Hopital Saint-Louis /ID# 222075
city: Rouen
country: France
facility: Centre Henri Becquerel /ID# 220986
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 221172
state: Baden-Wuerttemberg
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend /ID# 224917
state: Baden-Wuerttemberg
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf /ID# 221169
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln /ID# 234219
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 221168
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 221173
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 221170
city: Szekesfehervar
country: Hungary
facility: Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953
state: Fejer
city: Debrecen
country: Hungary
facility: Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703
state: Somogy
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704
state: Szabolcs-Szatmar-Bereg
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 221705
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 221083
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 221110
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 221896
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 233181
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 222006
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 221184
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 220815
state: Milano
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 221566
state: Aichi
city: 吉田郡
country: Japan
facility: University of Fukui University Hospital /ID# 221568
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 223473
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 222015
state: Fukushima
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital /ID# 222955
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Sapporo Hokuyu Hospital /ID# 222133
state: Hokkaido
city: Sapporo
country: Japan
facility: Aiiku Hospital /ID# 222351
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 221977
state: Hyogo
city: Higashi Ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center /ID# 222278
state: Ibaraki
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 221976
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital /ID# 222241
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Okayama Medical Center /ID# 222310
state: Okayama
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 222284
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center /ID# 222016
state: Saitama
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 222365
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 221574
state: Yamagata
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 221695
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 233171
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 221227
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 232353
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 221226
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 221224
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum /ID# 223010
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente /ID# 223012
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 221630
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 218937
city: Zwolle
country: Netherlands
facility: Isala /ID# 223011
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. M.Kopernika w Łodzi /ID# 221784
state: Lodzkie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667
state: Lubelskie
city: Warszawa
country: Poland
facility: Lux Med Onkologia - Szpital Szamocka /Id# 222203
state: Mazowieckie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia /ID# 221354
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne /ID# 222069
state: Pomorskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice /ID# 224728
city: Curitiba
country: Puerto Rico
facility: Hospital Erasto Gaertner /ID# 221341
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC /ID# 221010
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System /ID# 221012
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Hospital /ID# 221211
state: Kaluzhskaya Oblast
city: Pyatigorsk
country: Russian Federation
facility: Clinic UZI 4D /ID# 221215
state: Stavropol Skiy Kray
city: Moscow
country: Russian Federation
facility: Hospital n.a. V.V. Veresaev /ID# 225435
city: Moscow
country: Russian Federation
facility: MMCC Kommunarka /ID# 221213
city: Petrozavodsk
country: Russian Federation
facility: Republican hospital named after V.A. Baranov /ID# 221214
city: Sankt-Peterburg
country: Russian Federation
facility: Almazov National Medical Research Centre /ID# 221449
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 221274
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 221273
state: Cordoba
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quirón Salud Madrid /ID# 221275
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 221323
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 221271
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 221272
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 221297
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 221276
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 221270
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 223573
state: Kaohsiung
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 218987
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 218989
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center /ID# 218991
city: Melikgazi
country: Turkey
facility: Duplicate_Erciyes University Medical Fac /ID# 222090
state: Kayseri
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine /ID# 222094
city: Ankara
country: Turkey
facility: Ankara City Hospital /ID# 222093
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakul /ID# 222095
city: Samsun
country: Turkey
facility: Ondokuz mayis University Facul /ID# 222091
city: Tuzla
country: Turkey
facility: Acibadem Maslak Hastanesi /ID# 222072
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol /ID# 222510
state: Bristol, City Of
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 222514
state: Devon
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust /ID# 221237
state: Dorset
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 221231
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board /ID# 221236
state: Wales
city: Aberdeen
country: United Kingdom
facility: NHS Grampian /ID# 222509
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221233
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust /ID# 221240
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust /ID# 221232
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: