A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
3 other identifiers
interventional
536
26 countries
189
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2014
Longer than P75 for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 5, 2014
CompletedStudy Start
First participant enrolled
July 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2016
CompletedResults Posted
Study results publicly available
November 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2020
CompletedMay 18, 2021
April 1, 2021
2.1 years
May 1, 2014
July 13, 2018
April 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Major Molecular Response (MMR) at Month 12
MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (\<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to \[\>=\] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts \[\>=3000 ABL required\]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported.
Month 12
Secondary Outcomes (6)
Percentage of Participants With Major Molecular Response (MMR) Up to Month 18
Up to Month 18
Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48
Month 48
Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12
Up to Month 12
Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48
Month 48
Cumulative Incidence of Event Free Survival (EFS) Events
Up to Month 60
- +1 more secondary outcomes
Other Outcomes (9)
Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib
Pre-dose on Days 28, 56 and 84
Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib
Pre-dose on Days 28, 56 and 84
Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib
Pre-dose on Days 28, 56 and 84
- +6 more other outcomes
Study Arms (2)
Bosutinib
EXPERIMENTALBosutinib, 400 mg, oral administration once a day
Imatinib
ACTIVE COMPARATORImatinib, 400 mg, oral administration once a day
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).
- Adequate hepatic, renal and pancreatic function.
- Age ≥ 18 years.
You may not qualify if:
- 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.
- Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
- Extramedullary disease only.
- Major surgery or radiotherapy within 14 days of randomization.
- History of clinically significant or uncontrolled cardiac disease.
- 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.
- Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (189)
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Regional Medical Center, Cancer Care Center
Boise, Idaho, 83706, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Saint Alphonsus Caldwell Cancer Care Center
Caldwell, Idaho, 83605, United States
Saint Alphonsus Medical Center Nampa
Nampa, Idaho, 83686, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60621, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237, United States
PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D
Indianapolis, Indiana, 46237, United States
Cancer Center of Acadiana at Lafayette General Medical Center
Lafayette, Louisiana, 70503, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70503, United States
LSU Health Sciences Center-Shreveport
Shreveport, Louisiana, 71103, United States
University Health Shreveport
Shreveport, Louisiana, 71103, United States
Rcca Md Llc
Bethesda, Maryland, 20817, United States
University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy
Worcester, Massachusetts, 01655, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
St. Joseph Mercy Hospital - Inpatient Pharmacy
Ann Arbor, Michigan, 48106, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
St. Joseph Mercy-Brighton
Brighton, Michigan, 48114, United States
St. Joseph Mercy-Canton
Canton, Michigan, 48188, United States
Chelsea Community Hospital
Chelsea, Michigan, 48118-1370, United States
St. John Hospital&Medical Center
Detroit, Michigan, 48236, United States
St. John Hospital&Medical Center-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Van Elslander Cancer Center, Pharmacy
Grosse Pointe Woods, Michigan, 48236, United States
Minnesota Oncology Hematology, PA
Edina, Minnesota, 55435, United States
Park Nicollet Frauenshuh Cancer center
Saint Louis Park, Minnesota, 55426, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
North Mississippi Medical Center Hematology and Oncology Clinic
Tupelo, Mississippi, 38801, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
NYU Winthrop Hospital - Oncology / Hematology department
Mineola, New York, 11501, United States
NYU Winthrop Hospital - Pharmacy Department
Mineola, New York, 11501, United States
Beth Israel Medical Center
New York, New York, 10003, United States
University of Rochester Investigational Drug Pharmacy
Rochester, New York, 14642, United States
University of Rochester
Rochester, New York, 14642, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
UC Health Physicians Office South,
West Chester, Ohio, 45069, United States
MUSC University Hospital
Charleston, South Carolina, 29425, United States
MUSC University of South Carolina, Investigational Drug Services
Charleston, South Carolina, 29425, United States
MUSC-Hollings Cancer Center
Charleston, South Carolina, 29425, United States
GHS Cancer Institute
Easley, South Carolina, 29640, United States
GHS Cancer Institute
Greenville, South Carolina, 29605, United States
GHS Cancer Institute
Greenville, South Carolina, 29615, United States
GHS Cancer Institute
Greer, South Carolina, 29650, United States
GHS Cancer Institute
Seneca, South Carolina, 29672, United States
GHS Cancer Institute
Spartanburg, South Carolina, 29307, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
Utah Cancer Specialists
Murray, Utah, 84157, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Hospital
Salt Lake City, Utah, 84112, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
HSHS St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center
Green Bay, Wisconsin, 54303, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
St George Hospital - Hematology Department
Kogarah, New South Wales, 2217, Australia
Eastern Clinical Research Unit, Level 2
Box Hill, Victoria, 3128, Australia
UZ Ghent (University Hospital Ghent)
Ghent, 9000, Belgium
Department of Haematology at UZ Leuven (7 th Floor)
Leuven, 3000, Belgium
Hematology Department of CHU de Liège
Liège, 4000, Belgium
Hematology Department CHR Verviers
Verviers, 4800, Belgium
Horizon Health Network - The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
CHU de Québec - Université Laval
Québec, G1J 1Z4, Canada
Fakultní Nemocnice Brno
Brno, 625 00, Czechia
Fakultní Nemocnice Hradec Králové
Hradec Králové, 500 05, Czechia
Fakultní nemocnice Olomouc
Olomouc, 775 20, Czechia
Všeobecná fakultní Nemocnice v Praze
Prague, 128 08, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Roskilde Hospital
Roskilde, 4000, Denmark
Helsinki University Central Hospital
Helsinki, 00029 HUS, Finland
Oncologie Centre de Radiotherapie
Strasbourg, NC, 67000, France
Institut Bergonié
Bordeaux, 33076, France
private Practice of Pr Philippe Rousselot
Le Chesnay, 78157, France
private Practice of Dr. Viviane Dubruille
Nantes, 44093, France
Hôpital L'Archet 1-CHU Nice
Nice, 06202, France
Institut de Cancérologie du Gard - Hématologie Clinique
Nîmes, 30029, France
Pr Mauricette Michallet Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
INSERM CIC 1402 - CHU Poitiers
Poitiers, 86021, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059, France
Universitätsklinikum Bonn
Bonn, Rhineland-Palatinate, 53105, Germany
Uniklinikum Aachen
Aachen, 52074, Germany
Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie
Berlin, 13353, Germany
Universitätsklinikum Freiburg, Klinik für Innere Medizin I
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum
Hamburg, 20251, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin II
Jena Lobeda-Ost, 07747, Germany
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, 39104, Germany
Semmelweis Egyetem I. Belgyógyászat
Budapest, 1083, Hungary
Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék
Debrecen, 4032, Hungary
Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg
Győr, 9023, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.
Szeged, 6725, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet
Szolnok, 5000, Hungary
Hematology Department, Rambam Medical Centre
Haifa, 31096, Israel
Hematology Div. Davidoff Cancer Center, Rabin Medical Center
Petah Tikva, 49100, Israel
Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico
Catania, CT, 95123, Italy
USC Ematologia, A. O. Papa Giovanni XXIII
Bergamo, 24127, Italy
Policlinico S. Orsola - Malpighi,
Bologna, 40138, Italy
A.O. Brozu - P.O. Armando Businco
Cagliari, 09121, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
IRCCS - AOU San Martino_IST, Ematologia 1
Genova, 16132, Italy
Istituto Scientifico San Raffaele
Milan, 20132, Italy
Unità di Ricerca Clinica, U.O. Ematologia Adulti
Monza, 20900, Italy
A.O.U. Policlinico Università degli Studi di Napoli "Federico II"
Napoli, 80131, Italy
Dipartimento di ematologia
Reggio Calabria, 89124, Italy
ASL Roma 2 - Ospedale Sant'Eugenio
Roma, 00144, Italy
Hospital Angeles del Pedregal (S.A. de C.V.)
Mexico City, Mexico City, 10700, Mexico
Monterrey International Research Center
Monterrey, Nuevo León, 64000, Mexico
Klinische Farrnacologie en Apotheek
Amsterdam, North Holland, 1081 BT, Netherlands
VU University Medical Center
Amsterdam, North Holland, 1081 HV, Netherlands
Haukeland University Hospital Department of Hematology
Bergen, 5021, Norway
St. Olavs Hospital
Trondheim, 7006, Norway
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214, Poland
SPZOZ ZSM w Chorzowie Oddzial Hematologiczny
Chorzów, 41-500, Poland
Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach
Katowice, 40032, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii
Krakow, 31501, Poland
Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego
Lodz, 93510, Poland
SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie
Lublin, 20081, Poland
Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i
Wroclaw, 50-367, Poland
National University Hospital, Main Building
Singapore, 119228, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda
Bratislava, 851 07, Slovakia
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Department of Medical Oncology, University of Pretoria and Steve Biko
Pretoria, Gauteng, 0002, South Africa
Groenkloof Life hospital.
Pretoria, Gauteng, 0181, South Africa
Department of Haematology
Cape Town, Western Cape, 7935, South Africa
Hallym University Sacred Heart Hospital
Anyang-si, 14068, South Korea
Dong A University Hospital
Busan, 49201, South Korea
Keimyung University Dongsan Hospital
Daegu, 41931, South Korea
Chonbuk National University Hospital
Jeonju, 54907, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Seoul St. Mary's Hospital of the Catholic University of Korea
Seoul, 06591, South Korea
Hospital (Universitari(o)) Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario La Princesa
Madrid, Málaga, 28006, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic
Barcelona, 08036, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Virgen de la Salud
Toledo, 45004, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Linköping University Hospital
Linköping, SE-581 85, Sweden
Skåne University Hospital
Lund, SE-221 85, Sweden
Karolinska University Hospital Solna
Stockholm, SE-171 76, Sweden
Norrlands University Hospital
Umeå, SE-901 85, Sweden
Akademiska Hospital
Uppsala, SE-751 85, Sweden
China Medical University Hospital
Taichung, R.o.c., 40447, Taiwan
Chi-Mei Medical Center
Tainan, R.o.c., 710, Taiwan
Mackay Memorial Hospital
Taipei, R.o.c., 10449, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital
Bangkok, 10700, Thailand
MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department
Ivano-Frankivsk, 76008, Ukraine
Khmelnytskyi Regional Hospital, Hematology Department
Khmelnytskyi, 29000, Ukraine
State Institution "National research center for radiation medicine of NAMS of Ukraine",
Kyiv, 03115, Ukraine
State Institution "National research center for radiation medicine of NAMS of Ukraine"
Kyiv, 03115, Ukraine
transplantation department of hemotology and transplantology division within Clinical Radiology
Kyiv, 03115, Ukraine
Chair of internal medicine #2.
Kyiv, 04112, Ukraine
Kyiv City Clinical Hospital #9, Hematology department #1,
Kyiv, 04112, Ukraine
State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"
Lviv, 79044, Ukraine
Catherine Lewis Centre, Hammersmith Hospital
London, Greater London, W12 0HS, United Kingdom
Linda McCartney Centre
Liverpool, Merseyside, L7 8XP, United Kingdom
Department of Clinical Haematology
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Cancer & Haematology Centre, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Department of Haematology The Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Heartlands Hospital
Birmingham, WEST Midlands, B9 5SS, United Kingdom
St James's Institute of Oncology
Leeds, WEST Yorkshire, LS9 7TF, United Kingdom
Department of Haematology
Cardiff, CF14 4XW, United Kingdom
The Hope Clinical Trials Facility
Leicester, LE1 5WW, United Kingdom
Related Publications (5)
Garrett M, Knight B, Cortes JE, Deininger MW. Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia. Cancer Med. 2023 Sep;12(17):17981-17992. doi: 10.1002/cam4.6439. Epub 2023 Aug 8.
PMID: 37553873DERIVEDBrummendorf 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.
PMID: 35643868DERIVEDTakahashi 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.
PMID: 35235189DERIVEDChuah 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.
PMID: 33851349DERIVEDCortes 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.
PMID: 29091516DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- NOTE: Value was Open Label in old format; This study has an open-label design. Although most efficacy studies have a double blind design, this is not feasible in this trial, due to the complexity of the dose reduction and dose escalation schemes with tablets of various sizes, dosage strengths, as well as the number of tablets that would be required daily. However, the opportunity for bias is mitigated by the use of objective outcome measures (MMR, CCyR, CHR). The Investigators will be instructed to ensure that laboratory/pathology personnel are blinded to treatment information. For these reasons, an open-label, randomized study is appropriate.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 5, 2014
Study Start
July 15, 2014
Primary Completion
August 11, 2016
Study Completion
April 17, 2020
Last Updated
May 18, 2021
Results First Posted
November 14, 2018
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.