Clinical trial NCT02130557: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official title: A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Keywords: Leukemia
Myelogenous
Chronic
BCR-ABL Positive
Bosutinib
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Pathologic Processes
Imatinib
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 536
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: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Detailed description: The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.

Eligibility criteria: Inclusion Criteria:

1. Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).
2. Adequate hepatic, renal and pancreatic function.
3. Age ≥ 18 years.

Exclusion Criteria:

1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.
2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
3. Extramedullary disease only.
4. Major surgery or radiotherapy within 14 days of randomization.
5. History of clinically significant or uncontrolled cardiac disease.
6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included.
7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
9. Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.

Primary outcomes:
measure: Percentage of Participants With Major Molecular Response (MMR) at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants With Major Molecular Response (MMR) Up to Month 18
timeFrame: Up to Month 18
measure: Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48
timeFrame: Month 48
measure: Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12
timeFrame: Up to Month 12
measure: Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48
timeFrame: Month 48
measure: Cumulative Incidence of Event Free Survival (EFS) Events
timeFrame: Up to Month 60
measure: Overall Survival (OS) Rate
timeFrame: Up to Month 60
Other outcomes:
measure: Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib
timeFrame: Pre-dose on Days 28, 56 and 84
measure: Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib
timeFrame: Pre-dose on Days 28, 56 and 84
measure: Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib
timeFrame: Pre-dose on Days 28, 56 and 84
measure: Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) of Bosutinib
timeFrame: Pre-dose on Days 28, 56 and 84
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Baseline up to end of treatment (up to Month 60)
measure: Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03
timeFrame: Baseline up to end of treatment (up to Month 60)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to end of treatment (up to Month 60)
measure: Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
timeFrame: Baseline up to end of treatment (up to Month 60)
measure: Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0)
timeFrame: Baseline up to end of treatment (up to Month 60)
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center, Cancer Care Center
state: Idaho
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center
state: Idaho
city: Caldwell
country: United States
facility: Saint Alphonsus Caldwell Cancer Care Center
state: Idaho
city: Nampa
country: United States
facility: Saint Alphonsus Medical Center Nampa
state: Idaho
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation
state: Indiana
city: Indianapolis
country: United States
facility: PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D
state: Indiana
city: Lafayette
country: United States
facility: Cancer Center of Acadiana at Lafayette General Medical Center
state: Louisiana
city: Lafayette
country: United States
facility: Lafayette General Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center-Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: University Health Shreveport
state: Louisiana
city: Bethesda
country: United States
facility: Rcca Md Llc
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital - Inpatient Pharmacy
state: Michigan
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Brighton
country: United States
facility: St. Joseph Mercy-Brighton
state: Michigan
city: Canton
country: United States
facility: St. Joseph Mercy-Canton
state: Michigan
city: Chelsea
country: United States
facility: Chelsea Community Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital&Medical Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: St. John Hospital&Medical Center-Van Elslander Cancer Center
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Van Elslander Cancer Center, Pharmacy
state: Michigan
city: Edina
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center Hematology and Oncology Clinic
state: Mississippi
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Mineola
country: United States
facility: NYU Winthrop Hospital - Oncology / Hematology department
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital - Pharmacy Department
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Investigational Drug Pharmacy
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: West Chester
country: United States
facility: UC Health Physicians Office South,
state: Ohio
city: Charleston
country: United States
facility: MUSC University Hospital
state: South Carolina
city: Charleston
country: United States
facility: MUSC University of South Carolina, Investigational Drug Services
state: South Carolina
city: Charleston
country: United States
facility: MUSC-Hollings Cancer Center
state: South Carolina
city: Easley
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Greenville
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Greenville
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Greer
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Seneca
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Spartanburg
country: United States
facility: GHS Cancer Institute
state: South Carolina
city: Houston
country: United States
facility: The University of Texas, MD Anderson Cancer Center
state: Texas
city: Murray
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Kogarah
country: Australia
facility: St George Hospital - Hematology Department
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit, Level 2
state: Victoria
city: Ghent
country: Belgium
facility: UZ Ghent (University Hospital Ghent)
city: Leuven
country: Belgium
facility: Department of Haematology at UZ Leuven (7 th Floor)
city: Liège
country: Belgium
facility: Hematology Department of CHU de Liège
city: Verviers
country: Belgium
facility: Hematology Department CHR Verviers
city: Moncton
country: Canada
facility: Horizon Health Network - The Moncton Hospital
state: New Brunswick
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: CHU de Québec - Université Laval
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno
city: Hradec Králové
country: Czechia
facility: Fakultní Nemocnice Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Prague
country: Czechia
facility: Všeobecná fakultní Nemocnice v Praze
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Roskilde
country: Denmark
facility: Roskilde Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Strasbourg
country: France
facility: Oncologie Centre de Radiotherapie
state: NC
city: Bordeaux
country: France
facility: Institut Bergonié
city: Le Chesnay
country: France
facility: private Practice of Pr Philippe Rousselot
city: Nantes cedex 1
country: France
facility: private Practice of Dr. Viviane Dubruille
city: Nice
country: France
facility: Hôpital L'Archet 1-CHU Nice
city: Nimes
country: France
facility: Institut de Cancérologie du Gard - Hématologie Clinique
city: Pierre Bénite
country: France
facility: Pr Mauricette Michallet Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: INSERM CIC 1402 - CHU Poitiers
city: Toulouse cedex 9
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: RP
city: Aachen
country: Germany
facility: Uniklinikum Aachen
city: Berlin
country: Germany
facility: Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Innere Medizin I
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum
city: Jena Lobeda-Ost
country: Germany
facility: Universitätsklinikum Jena, Klinik für Innere Medizin II
city: Magdeburg
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Onkologie
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I. Belgyógyászat
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék
city: Györ
country: Hungary
facility: Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet
city: Haifa
country: Israel
facility: Hematology Department, Rambam Medical Centre
city: Petah-Tikva
country: Israel
facility: Hematology Div. Davidoff Cancer Center, Rabin Medical Center
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico
state: CT
city: Bergamo
country: Italy
facility: USC Ematologia, A. O. Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi,
city: Cagliari
country: Italy
facility: A.O. Brozu - P.O. Armando Businco
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: IRCCS - AOU San Martino_IST, Ematologia 1
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele
city: Monza
country: Italy
facility: Unità di Ricerca Clinica, U.O. Ematologia Adulti
city: Napoli
country: Italy
facility: A.O.U. Policlinico Università degli Studi di Napoli "Federico II"
city: Reggio Calabria
country: Italy
facility: Dipartimento di ematologia
city: Roma
country: Italy
facility: ASL Roma 2 - Ospedale Sant'Eugenio
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: Dong A University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital of the Catholic University of Korea
city: Mexico City
country: Mexico
facility: Hospital Angeles del Pedregal (S.A. de C.V.)
state: DF
city: Monterrey
country: Mexico
facility: Monterrey International Research Center
state: Nuevo LEON
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Klinische Farrnacologie en Apotheek
state: Noord-holland
city: Bergen
country: Norway
facility: Haukeland University Hospital Department of Hematology
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Gdansk
country: Poland
facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Chorzow
country: Poland
facility: SPZOZ ZSM w Chorzowie Oddzial Hematologiczny
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii
city: Lublin
country: Poland
facility: SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie
city: Wrocław
country: Poland
facility: Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i
city: Łódź
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego
city: Singapore
country: Singapore
facility: National University Hospital, Main Building
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Bratislava
country: Slovakia
facility: Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Pretoria
country: South Africa
facility: Department of Medical Oncology, University of Pretoria and Steve Biko
state: Gauteng
city: Pretoria
country: South Africa
facility: Groenkloof Life hospital.
state: Gauteng
city: Cape Town
country: South Africa
facility: Department of Haematology
state: Western CAPE
city: Badalona
country: Spain
facility: Hospital (Universitari(o)) Germans Trias i Pujol
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
state: Málaga
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Umeå
country: Sweden
facility: Norrlands University Hospital
city: Uppsala
country: Sweden
facility: Akademiska Hospital
city: Taichung city
country: Taiwan
facility: China Medical University Hospital
state: R.o.c.
city: Tainan City
country: Taiwan
facility: Chi-Mei Medical Center
state: R.o.c.
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
state: R.o.c.
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Muang
country: Thailand
facility: Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital
state: Chiang MAI
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital
city: Cherkasy
country: Ukraine
facility: MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Hospital, Hematology Department
city: Kyiv
country: Ukraine
facility: State Institution "National research center for radiation medicine of NAMS of Ukraine",
city: Kyiv
country: Ukraine
facility: State Institution "National research center for radiation medicine of NAMS of Ukraine"
city: Kyiv
country: Ukraine
facility: transplantation department of hemotology and transplantology division within Clinical Radiology
city: Kyiv
country: Ukraine
facility: Chair of internal medicine #2.
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #9, Hematology department #1,
city: Lviv
country: Ukraine
facility: State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"
city: London
country: United Kingdom
facility: Catherine Lewis Centre, Hammersmith Hospital
state: Greater London
city: Liverpool
country: United Kingdom
facility: Linda McCartney Centre
state: Merseyside
city: Nottingham
country: United Kingdom
facility: Department of Clinical Haematology
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Cancer & Haematology Centre, Churchill Hospital
state: Oxfordshire
city: Sheffield
country: United Kingdom
facility: Department of Haematology The Royal Hallamshire Hospital
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
state: WEST Midlands
city: Leeds
country: United Kingdom
facility: St James's Institute of Oncology
state: WEST Yorkshire
city: Cardiff
country: United Kingdom
facility: Department of Haematology
city: Leicester
country: United Kingdom
facility: The Hope Clinical Trials Facility
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Brummendorf TH, Cortes JE, Milojkovic D, Gambacorti-Passerini C, Clark RE, le Coutre P, Garcia-Gutierrez V, Chuah C, Kota V, Lipton JH, Rousselot P, Mauro MJ, Hochhaus A, Hurtado Monroy R, Leip E, Purcell S, Yver A, Viqueira A, Deininger MW; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022 Jul;36(7):1825-1833. doi: 10.1038/s41375-022-01589-y. Epub 2022 May 28.
citation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.
citation: Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, Brummendorf TH. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol. 2021 Jul;114(1):65-78. doi: 10.1007/s12185-021-03144-4. Epub 2021 Apr 13.
citation: Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, Dyagil I, Glushko N, Milojkovic D, le Coutre P, Garcia-Gutierrez V, Reilly L, Jeynes-Ellis A, Leip E, Bardy-Bouxin N, Hochhaus A, Brummendorf TH. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018 Jan 20;36(3):231-237. doi: 10.1200/JCO.2017.74.7162. Epub 2017 Nov 1.