Clinical trial NCT04468984: Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
Official title: Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C - Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Myelofibrosis (MF)
Keywords: ABT-263
Navitoclax
Ruxolitinib
MF
Myelofibrosis
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 330
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 (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF.

Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world.

In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. In Arm C, participants will receive navitoclax tablet by mouth once daily. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years.

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 treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.

  -- Has at least 2 symptoms each with an average score \>= 3 or an average total score of \>= 12, as measured by the MFSAF v4.0.
* Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.
* Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
* Must currently be on treatment or have received prior treatment with a single Janus Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in addition to the minimum splenomegaly and symptom burden also required for eligibility):

  * Treatment with ruxolitinib for \>= 24 weeks that was stopped due to lack of spleen response (refractory), or loss of spleen response or symptom control after a previous response (relapsed), or was continued despite relapsed/refractory status.
  * Treatment with ruxolitinib for \< 24 weeks with documented disease progression while on therapy as defined by any of the following:

    * Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
    * A \>= 100% increase in the palpable distance below the LCM in participants with measurable spleen distance 5 to 10 centimeters (cm) prior to the initiation of ruxolitinib.
    * A \>= 50% increase in the palpable distance below the LCM in participants with measurable spleen distance \> 10 cm prior to the initiation of ruxolitinib.
    * A spleen volume increase of \>= 25% (as assessed by Magnetic Resonance Imaging \[MRI\] or Computed Tomography \[CT\] scan) in participants with a spleen volume assessment prior to the initiation of ruxolitinib.
  * Prior treatment with ruxolitinib of at least 10 mg twice daily (BID) for \>= 28 days with intolerance defined as new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of \>= 30 mg but unable to reduce dose further due to lack of efficacy.

Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated ≥ Grade 3 toxicity.

* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Splenomegaly defined as palpable spleen measurement \>= 5 cm below left costal margin or spleen volume \>= 450 cm3 as assessed centrally by MRI or CT scan.
* Baseline platelet count \>= 100 × 10\^9/L.

Exclusion Criteria:

* Received prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, phosphoinositide 3- kinase and telomerase inhibitors (e.g., parsaclisib), prior use of \> 1 JAK2 inhibitor or stem cell transplant.
* Eligible for stem cell transplantation at the time of study entry.
* 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 mg daily) and low molecular weight heparin (LMWH).
* Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).

Primary outcomes:
measure: Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
timeFrame: At Week 24
Secondary outcomes:
measure: Arms A and B: Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)
timeFrame: Baseline (Week 0) Up to Week 24
measure: Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time
timeFrame: Baseline (Week 0) Up to Week 97
measure: Arms A and B: Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis
timeFrame: Baseline (Week 0) Up to Week 97
measure: Arms A and B: Percentage of Participants with Anemia Response
timeFrame: Baseline (Week 0) Up to Week 97
measure: Arms A and B: Percentage of Participants with Overall Survival
timeFrame: Last Visit Up to 5 Years
measure: Arms A and B: Percentage of Participants with Leukemia-free Survival
timeFrame: Last Visit Up to 5 Years
measure: Arms A and B: Percentage of Participants with Change in Fatigue
timeFrame: Baseline (Week 0) Up to Week 24
measure: Arms A and B: Time to Deterioration of Physical Functioning
timeFrame: Baseline (Week 0) Up to Week 97
measure: Arms A and B: Percentage of Participants with at Least 50% Reduction in TSS
timeFrame: Baseline (Week 0) Up to Week 97
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Res Ctr /ID# 222162
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 221826
state: Arkansas
city: Duarte
country: United States
facility: City of Hope /ID# 218996
state: California
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 271382
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center /ID# 271596
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 219009
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Ct /ID# 224542
state: California
city: Whittier
country: United States
facility: Icri /Id# 221967
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center /ID# 224229
state: Colorado
city: Augusta
country: United States
facility: Augusta University Georgia Cancer Center /ID# 219051
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute /ID# 224410
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center /ID# 271373
state: Illinois
city: Elk Grove Village
country: United States
facility: Northwest Oncology & Hematology - Elk Grove Village /ID# 222818
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Ctr /ID# 219048
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Blood & Marrow Transpl /ID# 221587
state: Indiana
city: New Orleans
country: United States
facility: Tulane Medical Center - New Orleans /ID# 222940
state: Louisiana
city: New Orleans
country: United States
facility: Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777
state: Louisiana
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland /ID# 222836
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 218998
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan /ID# 218463
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital /ID# 221190
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital /ID# 222705
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center /ID# 222287
state: Missouri
city: Florham Park
country: United States
facility: Summit Medical Group-Florham Park /ID# 222620
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 219047
state: New Jersey
city: Greenvale
country: United States
facility: The Cancer Institute at St. Francis Hospital /ID# 231782
state: New York
city: New York
country: United States
facility: Manhattan Hematology Oncology MHO Associates /ID# 223193
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center /ID# 222899
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center /ID# 222650
state: Ohio
city: Gettysburg
country: United States
facility: Pennsylvania Cancer Specialists & Research Institute /ID# 271376
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania /ID# 219001
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center /ID# 223955
state: Pennsylvania
city: Abilene
country: United States
facility: Texas Oncology - Abilene - Antilley Road /ID# 271379
state: Texas
city: Houston
country: United States
facility: Duplicate_Houston Methodist Hospital /ID# 223103
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Salt Lake Clinic /ID# 221962
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 223016
state: Virginia
city: Everett
country: United States
facility: Providence Everett /ID# 223130
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hosp /ID# 224368
state: Washington
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital /ID# 224468
state: Wisconsin
city: Darlinghurst
country: Australia
facility: The Kinghorn Cancer Centre /ID# 221097
state: New South Wales
city: East Albury
country: Australia
facility: Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 223848
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle /ID# 224324
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 221096
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 221099
state: Western Australia
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 221709
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220914
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH /ID# 220915
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 220919
state: Steiermark
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 220911
state: Wien
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 220912
city: Antwerp
country: Belgium
facility: ZAS Cadix /ID# 221468
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 224221
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Grand Hôpital De Charleroi - Notre Dame /ID# 224827
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent /ID# 220841
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 228150
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 221469
state: West-Vlaanderen
city: Sofiya
country: Bulgaria
facility: UMHAT Alexandrovska EAD /ID# 231652
state: Sofia
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 231650
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 231651
city: Varna
country: Bulgaria
facility: UMHAT Sveta Marina /ID# 234119
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 220887
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 238858
state: Ontario
city: Toronto
country: Canada
facility: University Health Network_Princess Margaret Cancer Centre /ID# 253942
state: Ontario
city: Levis
country: Canada
facility: CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center Research Institute /ID# 222614
state: Quebec
city: Quebec City
country: Canada
facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 220888
state: Quebec
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava /ID# 230801
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur /ID# 230799
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 230798
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek /ID# 231503
state: Osjecko-baranjska Zupanija
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 230800
state: Splitsko-dalmatinska Zupanija
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno - Jihlavská /ID# 220959
state: Brno-mesto
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 220969
city: Aalborg
country: Denmark
facility: Aalborg University Hospital /ID# 224391
state: Nordjylland
city: Roskilde
country: Denmark
facility: Roskilde Sygehus /ID# 224456
state: Sjælland
city: Nice
country: France
facility: Duplicate_CHU DE NICE-HOPITAL LARCHET II /ID# 256291
state: Alpes-Maritimes
city: Nimes CEDEX 9
country: France
facility: CHU NIMES - Hopital Caremeau /ID# 219128
state: Gard
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 222696
state: Gironde
city: Bobigny
country: France
facility: Hopital Avicenne - APHP /ID# 221287
state: Ile-de-France
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 219127
state: Pays-de-la-Loire
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 222695
state: Rhone
city: Chambery CEDEX
country: France
facility: Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 223771
state: Savoie
city: Angers
country: France
facility: Chu Angers /Id# 219129
city: Paris
country: France
facility: Hôpital Saint-Louis /ID# 221390
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 221529
state: Baden-Wuerttemberg
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend /ID# 223948
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 225025
state: Bayern
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock /ID# 224157
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695
state: Nordrhein-Westfalen
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH /ID# 224575
state: Sachsen
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346
state: Sachsen
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH /ID# 225034
city: Munich
country: Germany
facility: Klinikum rechts der Isar /ID# 221526
city: Patras
country: Greece
facility: Olympion General Clinic /ID# 261423
state: Achaia
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 221175
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179
city: RION Patras Achaia
country: Greece
facility: University General Hospital of Patras /ID# 221178
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 221463
city: Szekesfehervar
country: Hungary
facility: Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 220949
state: Fejer
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 220947
state: Hajdu-Bihar
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948
state: Somogy
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946
state: Szabolcs-Szatmar-Bereg
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 220955
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 220839
state: H_efa
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 219121
state: H_efa
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center /ID# 222973
state: H_efa
city: Ashdod
country: Israel
facility: Duplicate_Assuta Ashdod Medical Center /ID# 225281
state: HaDarom
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center /ID# 222972
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 225280
state: HaTsafon
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 219136
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 219135
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 219111
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Mt. Scopus /ID# 253394
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 219139
city: Bologna
country: Italy
facility: Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 221077
state: Emilia-Romagna
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 219090
state: Firenze
city: Rome
country: Italy
facility: Duplicate_Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita /ID# 219087
state: Lazio
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 225113
state: Monza E Brianza
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 224673
state: Napoli
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 221223
state: Piemonte
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 238438
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII /ID# 221222
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico - San Marco /ID# 219089
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 221078
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 221220
city: Udine
country: Italy
facility: Duplicate_University Hospital Santa Maria della Misericordia /ID# 221241
city: Varese
country: Italy
facility: ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 234183
city: Vicenza
country: Italy
facility: Azienda ULSS 8 Berica /ID# 221079
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 221598
state: Aichi
city: Aomori-shi
country: Japan
facility: Aomori Prefectural Central Hospital /ID# 221778
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 224546
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 226653
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 221158
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 221606
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 221877
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 224371
state: Gifu
city: Sapporo-shi
country: Japan
facility: Sapporo Hokuyu Hospital /ID# 221149
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 221156
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 223028
state: Ishikawa
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital /ID# 222044
state: Iwate
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital /ID# 223030
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto Shinto General Hospital /ID# 255645
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 223008
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 221665
state: Mie
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital /ID# 221821
state: Miyazaki
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital /ID# 223034
state: Niigata
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital /ID# 221690
state: Okayama
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 257289
state: Osaka
city: Suita-shi
country: Japan
facility: The University of Osaka Hospital /ID# 221159
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center /ID# 222334
state: Saitama
city: Izunokuni-shi
country: Japan
facility: Juntendo University Shizuoka Hospital /ID# 221780
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 221154
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital /ID# 221676
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 221540
state: Tokyo
city: Sumida-ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital /ID# 254774
state: Tokyo
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 221706
state: Yamanashi
city: Tokyo
country: Japan
facility: IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 257944
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 220980
state: Busan Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 220972
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 219060
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 221091
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219061
state: Seoul Teugbyeolsi
city: Papatoetoe
country: New Zealand
facility: Aotearoa Clinical Trials /ID# 232201
state: Auckland
city: Lodz
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161
state: Lodzkie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221124
state: Lubelskie
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160
state: Malopolskie
city: Warszawa
country: Poland
facility: Lux Med Onkologia - Szpital Szamocka /Id# 221265
state: Mazowieckie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia /ID# 221759
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne /ID# 221298
state: Pomorskie
city: Pila
country: Poland
facility: ARS-MEDICAL Sp. z o.o. /ID# 238336
state: Wielkopolskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031
state: Wielkopolskie
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice /ID# 224526
city: San Juan
country: Puerto Rico
facility: Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281
city: Moscow
country: Russian Federation
facility: Moscow State budget healthcare /ID# 221116
state: Moskva
city: Pyatigorsk
country: Russian Federation
facility: Clinic UZI 4D /ID# 221303
state: Stavropol Skiy Kray
city: Moscow
country: Russian Federation
facility: Hospital n.a. V.V. Veresaev /ID# 225221
city: Sankt-Peterburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115
city: Sankt-Peterburg
country: Russian Federation
facility: Almazov National Medical Research Centre /ID# 221114
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital /ID# 221302
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 231058
state: Beograd
city: Belgrade
country: Serbia
facility: Clin Hosp Ctr Bezanijska Kosa /ID# 231059
state: Beograd
city: Novi Sad
country: Serbia
facility: University Clinical Center Vojvodina /ID# 231057
city: Johannesburg
country: South Africa
facility: Duplicate_Wits Clinical Research Site /ID# 231554
state: Gauteng
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 231556
state: Gauteng
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 224617
state: A Coruna
city: Santiago de Compostela
country: Spain
facility: Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 221616
state: A Coruna
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias /ID# 224815
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 233727
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Dr. Negrin /ID# 220923
state: Las Palmas
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 220922
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 240979
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 253936
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 233726
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 224813
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga /ID# 221906
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 221904
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 221932
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 220920
city: Lund
country: Sweden
facility: Skane University Hospital Lund /ID# 220834
state: Skane Lan
city: Basel
country: Switzerland
facility: Duplicate_Universitätsspital Basel /ID# 221261
state: Basel-Stadt
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 223439
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218985
state: Kaohsiung
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying /ID# 221144
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 271207
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 271389
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 218979
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 271206
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 221147
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 218982
city: Tuzla
country: Turkey
facility: Medipol Mega Üniversite Hastanesi /ID# 271374
state: Istanbul
city: Ankara
country: Turkey
facility: Gulhane Askeri Tip Academy /ID# 224568
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Hastaneleri /ID# 271084
city: Edirne, Istanbul
country: Turkey
facility: Trakya University Medical Facu /ID# 224572
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 224570
city: Mersin
country: Turkey
facility: Mersin University Medical /ID# 224571
city: Samsun
country: Turkey
facility: Ondokuz mayis University Facul /ID# 224567
city: Kyiv
country: Ukraine
facility: Feofaniya Clinical Hospital of State Management of Affairs /ID# 271397
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 221041
state: Greater London
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust /ID# 224613
state: Lincolnshire
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust /ID# 221219
state: Norfolk
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221334
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 224378
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: