BEST – Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]
Study title
Bosutinib in Elderly Chronic Myeloid Leukemia (BEST)
Scientific title
Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors (ClinicalTrials.gov NCT02810990)
Type of study
Trial after therapy failure or intolerance
Current status
Recruitment completed
What is the purpose of the study
The purpose of this study is to evaluate the tyrosine kinase inhibitor (TKI) bosutinib in elderly patients who did not obtain any benefit with other drugs before.
The median age of newly diagnosed CML patients is about 56 years, and at least 40% of all newly diagnosed patients are over 60 years old. Particularly for these elderly patients, the choice of TKI must take into account the safety and tolerability profile of the drug. This study tests the efficacy, safety and tolerability of bosutinib in second-line treatment, beginning with a low dose (200 mg once daily) and adjusting subsequent doses (up to 400 mg once daily) based on molecular response and on adverse events.
Key inclusion criteria
Male or female patients 60 years of age or older with a molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase and prior first-line treatment with any other tyrosine kinase inhibitor.
Patients can be considered for inclusion in the study if they are intolerant to prior treatment, based on investigator and patient assessment, or have not responded to prior treatment (assessed according to any one of the ELN 2013 criteria).
Key exclusion criteria
Where can I find 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 sponsor
Gruppo Italiano Malattie EMatologiche dell’Adulto
Scientific lead / contact
Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy
Principal investigator
Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy
Study centers / principal investigators
Italy
Ancona
S. Rupoli
Bari
G. Specchia
Bologna
S. Orsola-Malpighi University Hospital
G. Rosti
Cagliari
“A. Businco”
E. Usala
Catania
F. Stagno
Cuneo
D. Rapezzi
Ferrara
F. Cavazzini
Genova
IRCCS San Martino
M. Gobbi
Meldola
IRST
A. Lucchesi
Messina
Policlinico G. Martino
C. Musolino
Milano
Ist. Nazionale Tumori
F. Spina
Milano
Osp. Maggiore Policlinico
A.Iurlo
Milano
Ospedale San Raffaele
F. Ciceri
Napoli
Univ. Studi Napoli “Federico II”
F. Pane
Novara
M. Lunghi
Orbassano
C. Rege Cambrin
Parma
M. Crugnola
Piacenza
D. Vallisa
Ravenna
M. Salvucci
Reggio Emilia
I. Capodanno
Rimini
A. L. Molinari
Roma
Gemelli
F. Sorà
Roma
Ospedale Sant’Eugenio
E. Abruzzese
Roma
San Giovanni Addolorata
M. Cedrone
Roma
S.Camillo Forlanini Hospital
Dr. S.Mancini
San Giovanni Rotondo
N. Cascavilla
Siena
M. Bocchia
Torino
Città della salute e della scienza
D. Ferrero
Verona
M. Bonifacio