Spots Global Cancer Trial Database for A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
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Trial Identification
Brief Title: 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 ID: NCT02130557
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Emory University Hospital, Atlanta, Georgia, United States
The Emory Clinic, Atlanta, Georgia, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Kaiser Permanente Hawaii, Honolulu, Hawaii, United States
Saint Alphonsus Regional Medical Center, Cancer Care Center, Boise, Idaho, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Saint Alphonsus Caldwell Cancer Care Center, Caldwell, Idaho, United States
Saint Alphonsus Medical Center Nampa, Nampa, Idaho, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, Indianapolis, Indiana, United States
PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D, Indianapolis, Indiana, United States
Cancer Center of Acadiana at Lafayette General Medical Center, Lafayette, Louisiana, United States
Lafayette General Medical Center, Lafayette, Louisiana, United States
LSU Health Sciences Center-Shreveport, Shreveport, Louisiana, United States
University Health Shreveport, Shreveport, Louisiana, United States
Rcca Md Llc, Bethesda, Maryland, United States
University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy, Worcester, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
St. Joseph Mercy Hospital - Inpatient Pharmacy, Ann Arbor, Michigan, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
St. Joseph Mercy-Brighton, Brighton, Michigan, United States
St. Joseph Mercy-Canton, Canton, Michigan, United States
Chelsea Community Hospital, Chelsea, Michigan, United States
St. John Hospital&Medical Center, Detroit, Michigan, United States
St. John Hospital&Medical Center-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States
Van Elslander Cancer Center, Pharmacy, Grosse Pointe Woods, Michigan, United States
Minnesota Oncology Hematology, PA, Edina, Minnesota, United States
Park Nicollet Frauenshuh Cancer center, Saint Louis Park, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
North Mississippi Medical Center Hematology and Oncology Clinic, Tupelo, Mississippi, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
NYU Winthrop Hospital - Oncology / Hematology department, Mineola, New York, United States
NYU Winthrop Hospital - Pharmacy Department, Mineola, New York, United States
Beth Israel Medical Center, New York, New York, United States
University of Rochester Investigational Drug Pharmacy, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States
FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
UC Health Physicians Office South,, West Chester, Ohio, United States
MUSC University Hospital, Charleston, South Carolina, United States
MUSC University of South Carolina, Investigational Drug Services, Charleston, South Carolina, United States
MUSC-Hollings Cancer Center, Charleston, South Carolina, United States
GHS Cancer Institute, Easley, South Carolina, United States
GHS Cancer Institute, Greenville, South Carolina, United States
GHS Cancer Institute, Greenville, South Carolina, United States
GHS Cancer Institute, Greer, South Carolina, United States
GHS Cancer Institute, Seneca, South Carolina, United States
GHS Cancer Institute, Spartanburg, South Carolina, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Utah Cancer Specialists, Murray, Utah, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital, Green Bay, Wisconsin, United States
HSHS St. Vincent Hospital, Green Bay, Wisconsin, United States
HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center, Green Bay, Wisconsin, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
St George Hospital - Hematology Department, Kogarah, New South Wales, Australia
Eastern Clinical Research Unit, Level 2, Box Hill, Victoria, Australia
UZ Ghent (University Hospital Ghent), Ghent, , Belgium
Department of Haematology at UZ Leuven (7 th Floor), Leuven, , Belgium
Hematology Department of CHU de Liège, Liège, , Belgium
Hematology Department CHR Verviers, Verviers, , Belgium
Horizon Health Network - The Moncton Hospital, Moncton, New Brunswick, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Lakeridge Health, Oshawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
CHU de Québec - Université Laval, Quebec, , Canada
Fakultní Nemocnice Brno, Brno, , Czechia
Fakultní Nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Všeobecná fakultní Nemocnice v Praze, Prague, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus, , Denmark
Roskilde Hospital, Roskilde, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Oncologie Centre de Radiotherapie, Strasbourg, NC, France
Institut Bergonié, Bordeaux, , France
private Practice of Pr Philippe Rousselot, Le Chesnay, , France
private Practice of Dr. Viviane Dubruille, Nantes cedex 1, , France
Hôpital L'Archet 1-CHU Nice, Nice, , France
Institut de Cancérologie du Gard - Hématologie Clinique, Nimes, , France
Pr Mauricette Michallet Centre Hospitalier Lyon Sud, Pierre Bénite, , France
INSERM CIC 1402 - CHU Poitiers, Poitiers, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse cedex 9, , France
Universitätsklinikum Bonn, Bonn, RP, Germany
Uniklinikum Aachen, Aachen, , Germany
Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie, Berlin, , Germany
Universitätsklinikum Freiburg, Klinik für Innere Medizin I, Freiburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Hamburg, , Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II, Jena Lobeda-Ost, , Germany
Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg, , Germany
Semmelweis Egyetem I. Belgyógyászat, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék, Debrecen, , Hungary
Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg, Györ, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz., Szeged, , Hungary
Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet, Szolnok, , Hungary
Hematology Department, Rambam Medical Centre, Haifa, , Israel
Hematology Div. Davidoff Cancer Center, Rabin Medical Center, Petah-Tikva, , Israel
Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico, Catania, CT, Italy
USC Ematologia, A. O. Papa Giovanni XXIII, Bergamo, , Italy
Policlinico S. Orsola - Malpighi,, Bologna, , Italy
A.O. Brozu - P.O. Armando Businco, Cagliari, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
IRCCS - AOU San Martino_IST, Ematologia 1, Genova, , Italy
Istituto Scientifico San Raffaele, Milano, , Italy
Unità di Ricerca Clinica, U.O. Ematologia Adulti, Monza, , Italy
A.O.U. Policlinico Università degli Studi di Napoli "Federico II", Napoli, , Italy
Dipartimento di ematologia, Reggio Calabria, , Italy
ASL Roma 2 - Ospedale Sant'Eugenio, Roma, , Italy
Hallym University Sacred Heart Hospital, Anyang-si, , Korea, Republic of
Dong A University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital of the Catholic University of Korea, Seoul, , Korea, Republic of
Hospital Angeles del Pedregal (S.A. de C.V.), Mexico City, DF, Mexico
Monterrey International Research Center, Monterrey, Nuevo LEON, Mexico
VU University Medical Center, Amsterdam, Noord Holland, Netherlands
Klinische Farrnacologie en Apotheek, Amsterdam, Noord-holland, Netherlands
Haukeland University Hospital Department of Hematology, Bergen, , Norway
St. Olavs Hospital, Trondheim, , Norway
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
SPZOZ ZSM w Chorzowie Oddzial Hematologiczny, Chorzow, , Poland
Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach, Katowice, , Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii, Kraków, , Poland
SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie, Lublin, , Poland
Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i, Wrocław, , Poland
Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego, Łódź, , Poland
National University Hospital, Main Building, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Tan Tock Seng Hospital, Singapore, , Singapore
Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda, Bratislava, , Slovakia
The Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Department of Medical Oncology, University of Pretoria and Steve Biko, Pretoria, Gauteng, South Africa
Groenkloof Life hospital., Pretoria, Gauteng, South Africa
Department of Haematology, Cape Town, Western CAPE, South Africa
Hospital (Universitari(o)) Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario La Princesa, Madrid, Málaga, Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic, Barcelona, , Spain
Hospital Universitario Gregorio Marañón, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Virgen de la Salud, Toledo, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Linköping University Hospital, Linköping, , Sweden
Skåne University Hospital, Lund, , Sweden
Karolinska University Hospital Solna, Stockholm, , Sweden
Norrlands University Hospital, Umeå, , Sweden
Akademiska Hospital, Uppsala, , Sweden
China Medical University Hospital, Taichung city, R.o.c., Taiwan
Chi-Mei Medical Center, Tainan City, R.o.c., Taiwan
Mackay Memorial Hospital, Taipei City, R.o.c., Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, , Taiwan
Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital, Muang, Chiang MAI, Thailand
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Phramongkutklao Hospital, Bangkok, , Thailand
Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, , Thailand
MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council, Cherkasy, , Ukraine
Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department, Ivano-Frankivsk, , Ukraine
Khmelnytskyi Regional Hospital, Hematology Department, Khmelnytskyi, , Ukraine
State Institution "National research center for radiation medicine of NAMS of Ukraine",, Kyiv, , Ukraine
State Institution "National research center for radiation medicine of NAMS of Ukraine", Kyiv, , Ukraine
transplantation department of hemotology and transplantology division within Clinical Radiology, Kyiv, , Ukraine
Chair of internal medicine #2., Kyiv, , Ukraine
Kyiv City Clinical Hospital #9, Hematology department #1,, Kyiv, , Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine", Lviv, , Ukraine
Catherine Lewis Centre, Hammersmith Hospital, London, Greater London, United Kingdom
Linda McCartney Centre, Liverpool, Merseyside, United Kingdom
Department of Clinical Haematology, Nottingham, Nottinghamshire, United Kingdom
Cancer & Haematology Centre, Churchill Hospital, Oxford, Oxfordshire, United Kingdom
Department of Haematology The Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom
Heartlands Hospital, Birmingham, WEST Midlands, United Kingdom
St James's Institute of Oncology, Leeds, WEST Yorkshire, United Kingdom
Department of Haematology, Cardiff, , United Kingdom
The Hope Clinical Trials Facility, Leicester, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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