B1871039 = Safety and Efficacy of Bosutinib in Ph+ CML Previously Treated with TKI

Study title

Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors [Europe, USA]

Scientific title

A Phase 4 Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors (EudraCT Number 2013-003250-25; Clinicaltrials.gov No. NCT02228382NCT02228382)

Indication and most important inclusion criteria

To be considered for inclusion in this study patients must have confirmed Philadelphia Chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) or confirmed BCR-ABL1 if Philadelphia Chromosome negative Chronic Myelogenous Leukemia (Ph- CML) from initial diagnosis.

They have previously been treated with one or more tyrosine kinase inhibitor (TKI) drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive CML. CML may be in any phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.

Patients must be 18 years or older and have adequate bone marrow, liver and kidney functions.
They should have an ECOG of 0-1 if in Chronic Phase or of 0-3 if they are treated fourth line (and beyond) in Chronic Phase or if they are in Accelerated Phase or Blast Phase.

Short description of intervention

This study evaluates the safety and efficacy of bosutinib in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors. It includes 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (after treatment with at least three other tyrosine kinase inhibitors).

Bosutinib will be administered at 500 mg once a day for up to 4 years.

Type of study

Other trials
In multiple countries

Current status

recruiting

Study sponsor

Pfizer

Scientific lead / contact

Jocelyn Leone

Principal investigator

Prof. Andreas Hochhaus
Universitätsklinikum Jena, Germany

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Austria

Innsbruck
Universitaet Innsbruck

Linz
Hospital "Barmherzige Schwestern"
Internal Medicine I

Belgium

Antwerpen
Ziekenhuis Netwerk Antwerpen


France

Bordeaux
Institut Bergonie
Bordeaux Cedex 09

Le Chesnay Cedex
Centre Hospitalier de Versailles Hopital Andre Mignot

Marseille
Centre Regional De Lutte Contre Le Cancer

Nice
Nice Hopital Archet 1
Service Hematologie clinic
Nice Cedex 3

Toulouse cedex 9
IUCT - ONCOPOLE
Toulouse cedex 9

Vandoeuvre-les-Nancy
CHU Brabois


Germany

Aachen
Uniklinik RWTH Aachen

Berlin
Charité Universitaetsmedizin Berlin

Cologne
Universitätsklinikum Köln

Hamburg
Universitaetsklinikum Hamburg-Eppendorf

Jena
Universitätsklinikum Jena

Mannheim
CML Studienzentrale
III. Medizinische Klinik, Universitätsmedizin Mannheim


Italy

Bari
U.O. Ematologia con Trapianto – A.O.U. Policlinico Consorziale

Bologna
A.O.U. Policlinico S. Orsola-Malpighi, U.O. Ematologia

Firenze
SOD Ematologia

Milano
Ospedale Niguarda Ca Granda - SC Ematologia

NapoliAOU Federico II

Orbassano
AOU San Luigi Gonzaga

Rome
Ospendale S. Eugenio – UOC Ematologia

 

Netherlands

Amsterdam
VU University Medical Center


Norway

Bergen
Haukeland universitetssjukehus

Trondheim
St Olavs Hospital


Spain

Barcelona
Hospital Clinic I Provincial de Barcelona

Barcelona
Hospital Universitari Vall d'Hebron

Madrid
Hospital Ramon y Cajal

Madrid
Hospital Universitario de La Princesa

Madrid
Hospital General Universitario Gregorio Maranon (HGUGM)

Pamplona
Complejo Hospitalario de Navarra Hematologia

Pozuelo De Alacron
Hospital Universitario Quiron Madrid

Salamanca
Clinico Universitario de Salamanca

Valencia
Hospital Universitari i Politecnic La Fe

Zaragoza
Hospital de Dia Quiron Zaragoza

 

Sweden
Lund
Skanes universitetssjukhus

Stockholm
Hematologiskt Centrum

Uppsala
Akademiska sjukhuset


USA

California
University of Southern California/Norris Comprehensive Cancer Center, Los Angeles

Keck Hospital of USC, Los Angeles

LAC&USC Medical Center, Los Angeles


Florida
University of Miami Hospital & Clinics, Miami


Indiana
Indiana Blood and Marrow Transplantation-Clinic
Indianapolis


Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore


Michigan
University of Michigan Health Systems, Ann Arbor


Missouri
Washington University School of Medicine, St. Louis

Siteman Cancer Center-West County, Creve Coeur

Siteman Cancer Center-South County, St. Louis

Barnes-Jewish Hospital, St. Louis


New York
Weill Cornell Medical College – Presbyterian Hospital

Washington
Seattle Cancer Care Alliance
Seattle