Clinical trial NCT04472598: Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelofibrosis (MF)
Keywords: Myelofibrosis
Navitoclax
Ruxolitinib
Cancer
ABT-263
TRANSFORM-1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 252
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: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.

Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide.

Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.

There may be a 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 tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera \[PPV\] - MF or Post Essential Thrombocytopenia \[PET\] - MF) .
* Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of randomization.

  -- Must have at least 2 symptoms with a score \>=3 or a total score of \>=12, as measured by the MFSAF v4.0.
* Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
* Has splenomegaly defined as spleen palpation measurement \>= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
* Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

* Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
* Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
* Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH).

Primary outcomes:
measure: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
timeFrame: At Week 24
Secondary outcomes:
measure: Change in Total Symptom Score (TSS)
timeFrame: Baseline (Week 0) Up to Week 24
measure: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% (SVR35)
timeFrame: Baseline (Week 0) Up to Week 96
measure: Duration of 35% Spleen Volume Reduction (SVR35)
timeFrame: Baseline (Week 0) Up to Week 96
measure: Change In Fatigue
timeFrame: Baseline (Week 0) Up to Week 24
measure: Change in Physical Functioning
timeFrame: Baseline (Week 0) Up to Week 24
measure: Percentage of Participants who achieve Anemia Response
timeFrame: Baseline (Week 0) Up to Week 96
measure: Overall Survival (OS)
timeFrame: Up To approximately 8 Years
measure: Leukemia-Free Survival
timeFrame: Up To approximately 8 Years
measure: Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis
timeFrame: Baseline (Week 0) Up to Week 96
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 221824
state: Arkansas
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 241646
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 218012
state: California
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton /ID# 222562
state: Colorado
city: Boca Raton
country: United States
facility: Lynn Cancer Institute, Boca /ID# 230687
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialist - South /ID# 221726
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North /ID# 221727
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East /ID# 221728
state: Florida
city: Atlanta
country: United States
facility: Emory University /ID# 221562
state: Georgia
city: Augusta
country: United States
facility: Augusta University Georgia Cancer Center /ID# 221551
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute /ID# 227272
state: Georgia
city: Chicago
country: United States
facility: Duplicate_Rush University Medical Center /ID# 221581
state: Illinois
city: Normal
country: United States
facility: Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Blood & Marrow Transpl /ID# 221586
state: Indiana
city: Fairway
country: United States
facility: University of Kansas Cancer Center /ID# 218144
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 221559
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 224261
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 218010
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan /ID# 221658
state: Michigan
city: Edina
country: United States
facility: Minnesota Oncology Hematology /ID# 227357
state: Minnesota
city: Kansas City
country: United States
facility: MidAmerica Division, Inc. /ID# 221743
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 221654
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health - Monter Cancer Center /ID# 222996
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College /ID# 220933
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 230488
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. /ID# 222556
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University /ID# 221584
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Ctr /ID# 218134
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Ctr /ID# 231689
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 217994
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 241813
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Salt Lake Clinic /ID# 221961
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah /ID# 221009
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 242682
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System /ID# 231691
state: Washington
city: Darlinghurst
country: Australia
facility: The Kinghorn Cancer Centre /ID# 221503
state: New South Wales
city: East Albury
country: Australia
facility: Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 231311
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital /ID# 221499
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 221803
state: New South Wales
city: Douglas
country: Australia
facility: Townsville University Hospital /ID# 229794
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Ctr /ID# 229795
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 221501
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 223203
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220813
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH /ID# 220901
state: Oberoesterreich
city: Graz
country: Austria
facility: Duplicate_Medizinische Universitaet Graz /ID# 220910
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 220906
state: Wien
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 220909
city: Antwerp
country: Belgium
facility: ZAS Cadix /ID# 221465
state: Antwerpen
city: Liège
country: Belgium
facility: CHU de Liège /ID# 218874
state: Liege
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 221127
state: Namur
city: Gent
country: Belgium
facility: UZ Gent /ID# 221125
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 229861
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 218806
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 221466
state: West-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 218805
city: Sofiya
country: Bulgaria
facility: UMHAT Alexandrovska EAD /ID# 231056
state: Sofia
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 231161
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi /ID# 231053
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 231028
city: Barrie
country: Canada
facility: Royal Victoria Hospital /ID# 222636
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 221752
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health - Oshawa /ID# 222080
state: Ontario
city: St Catharines
country: Canada
facility: Niagara Health System /ID# 230994
state: Ontario
city: Quebec City
country: Canada
facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754
state: Quebec
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava /ID# 230795
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur /ID# 231155
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 230793
state: Grad Zagreb
city: Split
country: Croatia
facility: Duplicate_Klinicki bolnicki centar Split /ID# 230796
state: Splitsko-dalmatinska Zupanija
city: Nimes CEDEX 9
country: France
facility: CHU NIMES - Hopital Caremeau /ID# 219114
state: Gard
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 222518
state: Gironde
city: Roubaix Cedex 1
country: France
facility: CH Roubaix - Hopital Victor Provo /ID# 219116
state: Hauts-de-France
city: Bobigny
country: France
facility: Hopital Avicenne - APHP /ID# 221286
state: Ile-de-France
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 219113
state: Pays-de-la-Loire
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 222913
state: Rhone
city: Chambery CEDEX
country: France
facility: Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 224506
state: Savoie
city: Angers
country: France
facility: Chu Angers /Id# 219115
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 221288
city: Paris
country: France
facility: AP-HP - Hopital Necker /ID# 231318
city: Strasbourg Cedex
country: France
facility: ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 221523
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: Haemato-Onkologie /ID# 221061
state: Bayern
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen /ID# 221519
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347
state: Sachsen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 221522
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH /ID# 230867
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 221520
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 230785
state: Attiki
city: Athens
country: Greece
facility: Duplicate_University General Hospital Attikon /ID# 230784
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 219120
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 221374
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center /ID# 222957
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 219137
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 219134
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 219110
state: Yerushalayim
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 220867
state: Emilia-Romagna
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 219086
state: Firenze
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083
state: Roma
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII /ID# 221907
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 241273
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico - San Marco /ID# 219085
city: Varese
country: Italy
facility: Duplicate_ASST Sette Laghi /ID# 219084
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 221537
state: Aichi
city: Chiba-shi
country: Japan
facility: Duplicate_Chiba University Hospital /ID# 239345
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 226093
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 221443
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 221783
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 222752
state: Fukushima
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital /ID# 240173
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital /ID# 242806
state: Gunma
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 221480
state: Gunma
city: Sapporo-shi
country: Japan
facility: Duplicate_Hokkaido University Hospital /ID# 242667
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital /ID# 246236
state: Hyogo
city: Hitachi-shi
country: Japan
facility: Hitachi General Hospital /ID# 240048
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 238424
state: Ishikawa
city: Kanoya-shi
country: Japan
facility: Medical Corporation Seijinkai Ikeda Hospital /ID# 242172
state: Kagoshima
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 238423
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 221664
state: Mie
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital /ID# 221483
state: Miyazaki
city: Kurashiki-shi
country: Japan
facility: Duplicate_Kawasaki Medical School Hospital /ID# 221481
state: Okayama
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital /ID# 221692
state: Okayama
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 221482
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 221479
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 221478
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center /ID# 222333
state: Saitama
city: Izunokuni-shi
country: Japan
facility: Juntendo University Shizuoka Hospital /ID# 221782
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 221405
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital /ID# 221674
state: Tokyo
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 221701
state: Yamanashi
city: Busan
country: Korea, Republic of
facility: Duplicate_Inje University Busan Paik Hospital /ID# 231667
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 222087
state: Busan Gwang Yeogsi
city: Daegu
country: Korea, Republic of
facility: Duplicate_Kyungpook National University Hospital /ID# 231666
state: Daegu Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 222089
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Duplicate_Seoul National University Bundang Hospital /ID# 219053
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 219055
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 219054
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 221068
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219056
state: Seoul Teugbyeolsi
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 218948
state: Gelderland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis /ID# 224015
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 218947
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 218949
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 230770
state: Auckland
city: Moscow
country: Russian Federation
facility: Moscow State budget healthcare /ID# 221025
state: Moskva
city: Petrozavodsk
country: Russian Federation
facility: Republican hospital named after V.A. Baranov /ID# 221412
state: Murmanskaya Oblast
city: Pyatigorsk
country: Russian Federation
facility: Clinic UZI 4D /ID# 221024
state: Stavropol Skiy Kray
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital /ID# 221028
city: Sankt-Peterburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029
city: Sankt-Peterburg
country: Russian Federation
facility: Almazov National Medical Research Centre /ID# 221033
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital /ID# 221027
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 230854
state: Beograd
city: Belgrade
country: Serbia
facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230946
state: Beograd
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac /ID# 230855
state: Pomoravski Okrug
city: Novi Sad
country: Serbia
facility: Duplicate_Clinical Center Vojvodina /ID# 230853
state: Vojvodina
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 232072
state: Gauteng
city: Johannesburg
country: South Africa
facility: Duplicate_Wits Clinical Research Site /ID# 232071
state: Gauteng
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 232073
state: Gauteng
city: Santiago de Compostela
country: Spain
facility: Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 222264
state: A Coruna
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 229936
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Dr. Negrin /ID# 220897
state: Las Palmas
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 230720
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 220913
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 229690
city: Madrid
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 220877
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 229691
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 220878
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 220875
city: Orebro
country: Sweden
facility: Orebro Universitetssjukhuset /ID# 220829
state: Orebro Lan
city: Lund
country: Sweden
facility: Duplicate_Skane University Hospital Lund /ID# 220835
state: Skane Lan
city: Gothenburg
country: Sweden
facility: Duplicate_Sahlgrenska University Hospital /ID# 218776
state: Vastra Gotalands Lan
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218984
state: Kaohsiung
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying /ID# 221145
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 218976
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 218978
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 221146
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 218983
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty /ID# 230759
city: Edirne, Istanbul
country: Turkey
facility: Trakya University Medical Facu /ID# 230754
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 230757
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 230753
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty /ID# 230758
city: Kharkiv
country: Ukraine
facility: Communal non-profit enterprise Regional Center of Oncology /ID# 230832
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 230834
city: Kyiv
country: Ukraine
facility: Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370
city: Lviv
country: Ukraine
facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 219185
state: Greater London
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust /ID# 231471
state: Lincolnshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 219192
state: Oxfordshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221333
city: Manchester
country: United Kingdom
facility: The Christie Hospital /ID# 219191
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: