AzTrials
AzTrials

Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) PositivePhase 3NCT02130557

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

A Phase 3 study testing Bosutinib and Imatinib in people with Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive, run by Pfizer at 189 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bosutinib and Imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
536 participants
Where
189 sitesin 26 countries
Study dates
15 Jul 2014to 17 Apr 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

189 sites in 26 countries.

189 sites in 26 countries

United States65 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • St. Joseph Mercy Hospital - Inpatient Pharmacy

    Ann Arbor, Michigan, 48106

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Rcca Md Llc

    Bethesda, Maryland, 20817

  • Saint Alphonsus Regional Medical Center, Cancer Care Center

    Boise, Idaho, 83706

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • St. Joseph Mercy-Brighton

    Brighton, Michigan, 48114

  • Saint Alphonsus Caldwell Cancer Care Center

    Caldwell, Idaho, 83605

  • St. Joseph Mercy-Canton

    Canton, Michigan, 48188

  • MUSC University Hospital

    Charleston, South Carolina, 29425

  • MUSC University of South Carolina, Investigational Drug Services

    Charleston, South Carolina, 29425

  • MUSC-Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Chelsea Community Hospital

    Chelsea, Michigan, 48118-1370

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60621

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • St. John Hospital&Medical Center

    Detroit, Michigan, 48236

  • GHS Cancer Institute

    Easley, South Carolina, 29640

  • Minnesota Oncology Hematology, PA

    Edina, Minnesota, 55435

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • HSHS St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center

    Green Bay, Wisconsin, 54303

  • GHS Cancer Institute

    Greenville, South Carolina, 29605

  • GHS Cancer Institute

    Greenville, South Carolina, 29615

  • GHS Cancer Institute

    Greer, South Carolina, 29650

  • St. John Hospital&Medical Center-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Van Elslander Cancer Center, Pharmacy

    Grosse Pointe Woods, Michigan, 48236

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Kaiser Permanente Hawaii

    Honolulu, Hawaii, 96819

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D

    Indianapolis, Indiana, 46237

  • Cancer Center of Acadiana at Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Winthrop Hospital - Oncology / Hematology department

    Mineola, New York, 11501

  • NYU Winthrop Hospital - Pharmacy Department

    Mineola, New York, 11501

  • Utah Cancer Specialists

    Murray, Utah, 84157

  • Saint Alphonsus Medical Center Nampa

    Nampa, Idaho, 83686

  • Beth Israel Medical Center

    New York, New York, 10003

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • University of Rochester Investigational Drug Pharmacy

    Rochester, New York, 14642

  • University of Rochester

    Rochester, New York, 14642

  • Park Nicollet Frauenshuh Cancer center

    Saint Louis Park, Minnesota, 55426

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • GHS Cancer Institute

    Seneca, South Carolina, 29672

  • LSU Health Sciences Center-Shreveport

    Shreveport, Louisiana, 71103

  • University Health Shreveport

    Shreveport, Louisiana, 71103

  • GHS Cancer Institute

    Spartanburg, South Carolina, 29307

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • North Mississippi Medical Center Hematology and Oncology Clinic

    Tupelo, Mississippi, 38801

  • UC Health Physicians Office South,

    West Chester, Ohio, 45069

  • University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy

    Worcester, Massachusetts, 01655

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Italy11 sites

  • USC Ematologia, A. O. Papa Giovanni XXIII

    Bergamo, 24127

  • Policlinico S. Orsola - Malpighi,

    Bologna, 40138

  • A.O. Brozu - P.O. Armando Businco

    Cagliari, 09121

  • Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico

    Catania, CT, 95123

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • IRCCS - AOU San Martino_IST, Ematologia 1

    Genova, 16132

  • Istituto Scientifico San Raffaele

    Milan, 20132

  • Unità di Ricerca Clinica, U.O. Ematologia Adulti

    Monza, 20900

  • A.O.U. Policlinico Università degli Studi di Napoli "Federico II"

    Naples, 80131

  • Dipartimento di ematologia

    Reggio Calabria, 89124

  • ASL Roma 2 - Ospedale Sant'Eugenio

    Roma, 00144

Other trials in Italy

Spain10 sites

  • Hospital (Universitari(o)) Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic

    Barcelona, 08036

  • Hospital Universitario La Princesa

    Madrid, Málaga, 28006

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France9 sites

  • Institut Bergonié

    Bordeaux, 33076

  • private Practice of Pr Philippe Rousselot

    Le Chesnay, 78157

  • private Practice of Dr. Viviane Dubruille

    Nantes, 44093

  • Hôpital L'Archet 1-CHU Nice

    Nice, 06202

  • Institut de Cancérologie du Gard - Hématologie Clinique

    Nîmes, 30029

  • Pr Mauricette Michallet Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • INSERM CIC 1402 - CHU Poitiers

    Poitiers, 86021

  • Oncologie Centre de Radiotherapie

    Strasbourg, NC, 67000

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31059

Other trials in France

Ukraine9 sites

  • MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council

    Cherkasy, 18009

  • Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department

    Ivano-Frankivsk, 76008

  • Khmelnytskyi Regional Hospital, Hematology Department

    Khmelnytskyi, 29000

  • State Institution "National research center for radiation medicine of NAMS of Ukraine",

    Kyiv, 03115

  • State Institution "National research center for radiation medicine of NAMS of Ukraine"

    Kyiv, 03115

  • transplantation department of hemotology and transplantology division within Clinical Radiology

    Kyiv, 03115

  • Chair of internal medicine #2.

    Kyiv, 04112

  • Kyiv City Clinical Hospital #9, Hematology department #1,

    Kyiv, 04112

  • State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"

    Lviv, 79044

Other trials in Ukraine

United Kingdom9 sites

  • Heartlands Hospital

    Birmingham, WEST Midlands, B9 5SS

  • Department of Haematology

    Cardiff, CF14 4XW

  • St James's Institute of Oncology

    Leeds, WEST Yorkshire, LS9 7TF

  • The Hope Clinical Trials Facility

    Leicester, LE1 5WW

  • Linda McCartney Centre

    Liverpool, Merseyside, L7 8XP

  • Catherine Lewis Centre, Hammersmith Hospital

    London, Greater London, W12 0HS

  • Department of Clinical Haematology

    Nottingham, Nottinghamshire, NG5 1PB

  • Cancer & Haematology Centre, Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

  • Department of Haematology The Royal Hallamshire Hospital

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Canada7 sites

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Horizon Health Network - The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • CHU de Québec - Université Laval

    Québec, G1J 1Z4

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany7 sites

  • Uniklinikum Aachen

    Aachen, 52074

  • Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, Rhineland-Palatinate, 53105

  • Universitätsklinikum Freiburg, Klinik für Innere Medizin I

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

    Hamburg, 20251

  • Universitätsklinikum Jena, Klinik für Innere Medizin II

    Jena Lobeda-Ost, 07747

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Magdeburg, 39104

Other trials in Germany

Poland7 sites

  • SPZOZ ZSM w Chorzowie Oddzial Hematologiczny

    Chorzów, 41-500

  • Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

  • Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach

    Katowice, 40032

  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii

    Krakow, 31501

  • Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego

    Lodz, 93510

  • SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie

    Lublin, 20081

  • Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i

    Wroclaw, 50-367

Other trials in Poland

Hungary6 sites

  • Semmelweis Egyetem I. Belgyógyászat

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék

    Debrecen, 4032

  • Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg

    Győr, 9023

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.

    Szeged, 6725

  • Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet

    Szolnok, 5000

Other trials in Hungary

South Korea6 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068

  • Dong A University Hospital

    Busan, 49201

  • Keimyung University Dongsan Hospital

    Daegu, 41931

  • Chonbuk National University Hospital

    Jeonju, 54907

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Seoul St. Mary's Hospital of the Catholic University of Korea

    Seoul, 06591

Other trials in South Korea

Sweden5 sites

  • Linköping University Hospital

    Linköping, SE-581 85

  • Skåne University Hospital

    Lund, SE-221 85

  • Karolinska University Hospital Solna

    Stockholm, SE-171 76

  • Norrlands University Hospital

    Umeå, SE-901 85

  • Akademiska Hospital

    Uppsala, SE-751 85

Other trials in Sweden

Belgium4 sites

  • UZ Ghent (University Hospital Ghent)

    Ghent, 9000

  • Department of Haematology at UZ Leuven (7 th Floor)

    Leuven, 3000

  • Hematology Department of CHU de Liège

    Liège, 4000

  • Hematology Department CHR Verviers

    Verviers, 4800

Other trials in Belgium

Czechia4 sites

  • Fakultní Nemocnice Brno

    Brno, 625 00

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní nemocnice Olomouc

    Olomouc, 775 20

  • Všeobecná fakultní Nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

South Africa4 sites

  • Department of Haematology

    Cape Town, Western Cape, 7935

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Department of Medical Oncology, University of Pretoria and Steve Biko

    Pretoria, Gauteng, 0002

  • Groenkloof Life hospital.

    Pretoria, Gauteng, 0181

Other trials in South Africa

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, R.o.c., 40447

  • Chi-Mei Medical Center

    Tainan, R.o.c., 710

  • Mackay Memorial Hospital

    Taipei, R.o.c., 10449

Other trials in Taiwan

Thailand4 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital

    Bangkok, 10700

  • Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital

    Muang, Chiang Mai, 50200

Other trials in Thailand

Denmark3 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Roskilde Hospital

    Roskilde, 4000

Other trials in Denmark

Singapore3 sites

  • National University Hospital, Main Building

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Australia2 sites

  • Eastern Clinical Research Unit, Level 2

    Box Hill, Victoria, 3128

  • St George Hospital - Hematology Department

    Kogarah, New South Wales, 2217

Other trials in Australia

Israel2 sites

  • Hematology Department, Rambam Medical Centre

    Haifa, 31096

  • Hematology Div. Davidoff Cancer Center, Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Mexico2 sites

  • Hospital Angeles del Pedregal (S.A. de C.V.)

    Mexico City, Mexico City, 10700

  • Monterrey International Research Center

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Netherlands2 sites

  • Klinische Farrnacologie en Apotheek

    Amsterdam, North Holland, 1081 BT

  • VU University Medical Center

    Amsterdam, North Holland, 1081 HV

Other trials in Netherlands

Norway2 sites

  • Haukeland University Hospital Department of Hematology

    Bergen, 5021

  • St. Olavs Hospital

    Trondheim, 7006

Other trials in Norway

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00029 HUS

Other trials in Finland

Slovakia1 site

  • Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda

    Bratislava, 851 07

Other trials in Slovakia

About this study

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

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Read the 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.

Being tested
Bosutinib, Imatinib
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
Medical subject headings
Leukemia, Bronchiolitis Obliterans Syndrome, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Neoplasms by Histologic Type, Bone Marrow Diseases, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BosutinibDrug

    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.

  • ImatinibDrug

    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.

Study groups in NCT02130557
Study groupRoleWhat they receive
BosutinibExperimentalBosutinib, 400 mg, oral administration once a day
Receives: Drug: Bosutinib
ImatinibActive comparatorImatinib, 400 mg, oral administration once a day
Receives: Drug: Imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 12

Secondary outcomes (6)

  1. Percentage of Participants With Major Molecular Response (MMR) Up to Month 18

    MMR was defined as a ratio of BCR-ABL/ABL <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative RT-qPCR. The percentage of participants with MMR for up to Month 18 are reported.

    Measured: Up to Month 18

  2. Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48

    The Kaplan-Meier curve was generated based on the first date of MMR until the date of the confirmed loss of MMR or censoring, objectively documented, for responders only. Confirmed loss of MMR was BCR-ABL/ABL IS ratio >0.1% in association with a >=5-fold increase in BCR-ABL/ABL IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase (AP) or blast phase (BP) CML.

    Measured: Month 48

  3. Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12

    Complete Cytogenetic Response (CCyR) was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. The percentage of participants with CCyR for up to Month 12 are reported.

    Measured: Up to Month 12

  4. Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48

    The Kaplan-Meier curve was generated based on the first date of CCyR until the date of the confirmed loss of CCyR or censoring, objectively documented, for responders only. Confirmed loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, PD or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to AP or BP CML.

    Measured: Month 48

  5. Cumulative Incidence of Event Free Survival (EFS) Events

    EFS was defined as time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR (chronic phase, AP, or BP) confirmed by 2 assessments at least 4 weeks apart. Loss of CHR was defined as appearance of any of the following: WBC count that rises to >20.0*10^9/L, platelet count rises to >=600*10^9/L, appearance of palpable spleen or other extramedullary involvement proven by biopsy, appearance of 5% myelocytes in peripheral blood, appearance of blasts or promyelocytes in peripheral blood. Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of <100 metaphases confirmed by follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS was defined as percentage of participants with EFS event at Month 60 and was adjusted for competing risk of treatment discontinuation without event.

    Measured: Up to Month 60

  6. Overall Survival (OS) Rate

    OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure.

    Measured: Up to Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2014 (estimated)
  2. Study start15 Jul 2014
  3. Primary completion11 Aug 2016
  4. Study completion17 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
536 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02130557
Sponsor's protocol ID
AV001
Other IDs
2013-005101-31, B1871053
Status last verified
Apr 2021
First submitted
1 May 2014
Last updated
18 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37553873

  • 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.

    PubMed 35643868

  • 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.

    PubMed 35235189

  • 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.

    PubMed 33851349

  • 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.

    PubMed 29091516

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bosutinib and Imatinib in people with Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive, run by Pfizer at 189 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Italy, Spain, France, Ukraine and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Major Molecular Response (MMR) at Month 12 (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130557, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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