536
Participants
Start Date
July 15, 2014
Primary Completion Date
August 11, 2016
Study Completion Date
April 17, 2020
Bosutinib
Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.\[1\] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML.
Imatinib
"Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial.~Imatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator."
Chi-Mei Medical Center, Tainan City
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Semmelweis Egyetem I. Belgyógyászat, Budapest
The Medical Oncology Centre of Rosebank, Johannesburg
St George Hospital - Hematology Department, Kogarah
Department of Haematology at UZ Leuven (7 th Floor), Leuven
Eastern Clinical Research Unit, Level 2, Box Hill
Hematology Department of CHU de Liège, Liège
Roskilde Hospital, Roskilde
Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék, Debrecen
Hematology Department CHR Verviers, Verviers
Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet, Szolnok
Haukeland University Hospital Department of Hematology, Bergen
Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz., Szeged
St. Olavs Hospital, Trondheim
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár
Department of Haematology, Cape Town
Aarhus University Hospital, Aarhus
UZ Ghent (University Hospital Ghent), Ghent
Aalborg University Hospital, Aalborg
Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg, Győr
Beth Israel Medical Center, New York
King Chulalongkorn Memorial Hospital, Bangkok
Phramongkutklao Hospital, Bangkok
Mackay Memorial Hospital, Taipei
Hospital Angeles del Pedregal (S.A. de C.V.), Mexico City
Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok
NYU Winthrop Hospital - Oncology / Hematology department, Mineola
NYU Winthrop Hospital - Pharmacy Department, Mineola
Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie, Berlin
Hallym University Sacred Heart Hospital, Anyang-si
University of Rochester Investigational Drug Pharmacy, Rochester
University of Rochester, Rochester
IRCCS - AOU San Martino_IST, Ematologia 1, Genova
"MI Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council", Cherkasy
SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie, Lublin
Istituto Scientifico San Raffaele, Milan
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Hamburg
Rcca Md Llc, Bethesda
Unità di Ricerca Clinica, U.O. Ematologia Adulti, Monza
USC Ematologia, A. O. Papa Giovanni XXIII, Bergamo
Hospital Universitario La Princesa, Madrid
Hospital Universitario Gregorio Marañón, Madrid
Hospital Ramón y Cajal, Madrid
Hospital Clinico San Carlos, Madrid
FirstHealth Moore Regional Hospital, Pinehurst
FirstHealth Outpatient Cancer Center, Pinehurst
Khmelnytskyi Regional Hospital, Hematology Department, Khmelnytskyi
GHS Cancer Institute, Spartanburg
MUSC University Hospital, Charleston
MUSC University of South Carolina, Investigational Drug Services, Charleston
MUSC-Hollings Cancer Center, Charleston
GHS Cancer Institute, Greenville
GHS Cancer Institute, Greenville
GHS Cancer Institute, Easley
GHS Cancer Institute, Greer
GHS Cancer Institute, Seneca
Institut de Cancérologie du Gard - Hématologie Clinique, Nîmes
Emory University Hospital, Atlanta
The Emory Clinic, Atlanta
Winship Cancer Institute, Emory University, Atlanta
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse
Hematology Department, Rambam Medical Centre, Haifa
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii, Krakow
Institut Bergonié, Bordeaux
Hospital Universitario de Salamanca, Salamanca
North Mississippi Medical Center Hematology and Oncology Clinic, Tupelo
Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg
Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach, Katowice
Policlinico S. Orsola - Malpighi,, Bologna
China Medical University Hospital, Taichung
Keimyung University Dongsan Hospital, Daegu
private Practice of Dr. Viviane Dubruille, Nantes
Hospital Virgen de la Salud, Toledo
UC Health Physicians Office South,, West Chester
University of Cincinnati Medical Center, Cincinnati
Hospital Clínico Universitario de Valencia, Valencia
Indiana Blood and Marrow Transplantation, Indianapolis
PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D, Indianapolis
St. Joseph Mercy Hospital - Inpatient Pharmacy, Ann Arbor
St. Joseph Mercy Hospital, Ann Arbor
St. Joseph Mercy-Brighton, Brighton
St. Joseph Mercy-Canton, Canton
St. John Hospital&Medical Center, Detroit
St. John Hospital&Medical Center-Van Elslander Cancer Center, Grosse Pointe Woods
Van Elslander Cancer Center, Pharmacy, Grosse Pointe Woods
Hematology Div. Davidoff Cancer Center, Rabin Medical Center, Petah Tikva
Dong A University Hospital, Busan
Azienda Ospedaliero Universitaria Careggi, Florence
Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Muang
Uniklinikum Aachen, Aachen
Universitätsklinikum Bonn, Bonn
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee
HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital, Green Bay
HSHS St. Vincent Hospital, Green Bay
HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center, Green Bay
Chonbuk National University Hospital, Jeonju
Lakeview Hospital, Stillwater
Park Nicollet Frauenshuh Cancer center, Saint Louis Park
Minnesota Oncology Hematology, PA, Edina
University of Illinois Cancer Center, Chicago
John H. Stroger, Jr. Hospital of Cook County, Chicago
Monterrey International Research Center, Monterrey
Oncologie Centre de Radiotherapie, Strasbourg
Nebraska Methodist Hospital, Omaha
Pr Mauricette Michallet Centre Hospitalier Lyon Sud, Pierre-Bénite
Cancer Center of Acadiana at Lafayette General Medical Center, Lafayette
Lafayette General Medical Center, Lafayette
LSU Health Sciences Center-Shreveport, Shreveport
University Health Shreveport, Shreveport
Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department, Ivano-Frankivsk
The University of Texas, MD Anderson Cancer Center, Houston
private Practice of Pr Philippe Rousselot, Le Chesnay
"State Institution Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine", Lviv
Universitätsklinikum Freiburg, Klinik für Innere Medizin I, Freiburg im Breisgau
"A.O.U. Policlinico Università degli Studi di Napoli Federico II", Napoli
Saint Alphonsus Caldwell Cancer Care Center, Caldwell
Saint Alphonsus Medical Center Nampa, Nampa
Saint Alphonsus Regional Medical Center, Cancer Care Center, Boise
Saint Alphonsus Regional Medical Center, Boise
Utah Cancer Specialists, Salt Lake City
Huntsman Cancer Hospital, Salt Lake City
Huntsman Cancer Institute, Salt Lake City
Utah Cancer Specialists, Murray
INSERM CIC 1402 - CHU Poitiers, Poitiers
San Juan Oncology Associates, Farmington
Dipartimento di ematologia, Reggio Calabria
Pacific Cancer Medical Center, Inc., Anaheim
Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego, Lodz
"Azienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele - P.O. G. Rodolico", Catania
Kaiser Permanente Hawaii, Honolulu
Virginia Mason Medical Center, Seattle
Seattle Cancer Care Alliance, Seattle
National University Hospital, Main Building, Singapore
Singapore General Hospital, Singapore
Tan Tock Seng Hospital, Singapore
University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy, Worcester
University of Massachusetts Memorial Medical Center, Worcester
Chelsea Community Hospital, Chelsea
Hackensack University Medical Center, Hackensack
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack
Horizon Health Network - The Moncton Hospital, Moncton
Juravinski Cancer Centre, Hamilton
Lakeridge Health, Oshawa
Princess Margaret Cancer Centre, Toronto
Hopital Maisonneuve-Rosemont, Montreal
Saskatoon Cancer Centre, Saskatoon
CHU de Québec - Université Laval, Québec
Fakultní Nemocnice Brno, Brno
Fakultní Nemocnice Hradec Králové, Hradec Králové
Fakultní nemocnice Olomouc, Olomouc
Všeobecná fakultní Nemocnice v Praze, Prague
Helsinki University Central Hospital, Helsinki
Hôpital L'Archet 1-CHU Nice, Nice
Universitätsklinikum Jena, Klinik für Innere Medizin II, Jena Lobeda-Ost
A.O. Brozu - P.O. Armando Businco, Cagliari
ASL Roma 2 - Ospedale Sant'Eugenio, Roma
Klinische Farrnacologie en Apotheek, Amsterdam
VU University Medical Center, Amsterdam
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne, Gdansk
SPZOZ ZSM w Chorzowie Oddzial Hematologiczny, Chorzów
Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i, Wroclaw
Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda, Bratislava
Department of Medical Oncology, University of Pretoria and Steve Biko, Pretoria
Groenkloof Life hospital., Pretoria
Kangbuk Samsung Hospital, Seoul
Seoul St. Mary's Hospital of the Catholic University of Korea, Seoul
Hospital (Universitari(o)) Germans Trias i Pujol, Badalona
Hospital Vall d'Hebron, Barcelona
Hospital Clínic, Barcelona
Linköping University Hospital, Linköping
Skåne University Hospital, Lund
Karolinska University Hospital Solna, Stockholm
Norrlands University Hospital, Umeå
Akademiska Hospital, Uppsala
"State Institution National research center for radiation medicine of NAMS of Ukraine,", Kyiv
"State Institution National research center for radiation medicine of NAMS of Ukraine", Kyiv
transplantation department of hemotology and transplantology division within Clinical Radiology, Kyiv
Chair of internal medicine #2., Kyiv
Kyiv City Clinical Hospital #9, Hematology department #1,, Kyiv
Catherine Lewis Centre, Hammersmith Hospital, London
Linda McCartney Centre, Liverpool
Department of Clinical Haematology, Nottingham
Cancer & Haematology Centre, Churchill Hospital, Oxford
Department of Haematology The Royal Hallamshire Hospital, Sheffield
Heartlands Hospital, Birmingham
St James's Institute of Oncology, Leeds
Department of Haematology, Cardiff
The Hope Clinical Trials Facility, Leicester
Lead Sponsor
Pfizer
INDUSTRY